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OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure (ATALANTE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02654587
Recruitment Status : Terminated (due to COVID-19)
First Posted : January 13, 2016
Results First Posted : February 2, 2024
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
OSE Immunotherapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Small Cell Lung Cancer
Interventions Biological: OSE2101
Drug: Docetaxel
Drug: Pemetrexed
Enrollment 219
Recruitment Details From Feb 2016 to Apr 2020, patients with advanced NSCLC were recruited in clinics or hospitals specialized in oncology in Europe, US and Israel to prescreen potential patients for HLA-A2 typing (by central lab). Only HLA-A2 positive patients who fulfilled all eligibility criteria were randomized. A total of 219 patients with ICI resistance were randomized, including 118 patients with ICI secondary resistance (disease progression after ICI >= 12 weeks - primary population for efficacy analysis)
Pre-assignment Details Only patient with HLA-A2 positive phenotype were eligible
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and therafter every 12 weeks Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Period Title: Overall Study
Started [1] 139 80
Completed [2] 116 65
Not Completed 23 15
Reason Not Completed
patient alive at end of study             22             8
Withdrawal by Subject             1             7
[1]
Patients with ICI secondary resistance
[2]
primary endpoint is overall survival patient completed has been defined as patient deceased at the end of study
Arm/Group Title OSE2101 Docetaxel or Pemetrexed Total
Hide Arm/Group Description Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines Total of all reporting groups
Overall Number of Baseline Participants 139 80 219
Hide Baseline Analysis Population Description
219 HLA-A2 positive patients with advanced NSCLC who progressed after sequential or concurrent chemotherapy and Immune Checkpoint Inhibitor (either primary or secondary resistance) were randomized. Safety analysis was done in overall population. Primary efficacy analysis was carried out from stratification factor in subgroup of patients with ICI secondary resistance (who had a disease progression after ICI second line > or equal to 12 weeks)
Age, Categorical   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
All randomized patients with ICI primary and secondary resistance Number Analyzed 139 participants 80 participants 219 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
69
  49.6%
45
  56.3%
114
  52.1%
>=65 years
70
  50.4%
35
  43.8%
105
  47.9%
[1]
Measure Description: Age at study entry
[2]
Measure Analysis Population Description: Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line > or equal to 12 weeks identified from the stratification factor (previous line of ICI). Safety analysis was done in all patients.
Age, Continuous   [1] [2] 
Mean (Full Range)
Unit of measure:  Years
All randomized patients with ICI primary and secondary resistance Number Analyzed 139 participants 80 participants 219 participants
65.3
(41 to 86)
63.6
(43 to 81)
64.7
(41 to 86)
[1]
Measure Description: Age at study entry
[2]
Measure Analysis Population Description: Final analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line > or equal to 12 weeks identified from the stratification factor (previous line of ICI)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
All patients with ICI primary and secondary resistance Number Analyzed 139 participants 80 participants 219 participants
Female
40
  28.8%
24
  30.0%
64
  29.2%
Male
99
  71.2%
56
  70.0%
155
  70.8%
[1]
Measure Analysis Population Description: Primary efficacy analysis was carried out in the subgroup of patients with ICI secondary resistance defined as as disease progression after ICI second line > or equal to 12 weeks identified from the stratification factor (previous line of ICI)/ Safety analysis was done in all patients
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
All patients with ICI primary and secondary resistance Number Analyzed 130 participants 78 participants 208 participants
white
124
  95.4%
76
  97.4%
200
  96.2%
Black or African American
4
   3.1%
2
   2.6%
6
   2.9%
Asian
2
   1.5%
0
   0.0%
2
   1.0%
[1]
Measure Analysis Population Description: Missing data in 11 patients (n=9 in OSE2101 arm, n=2 in docetaxel or pemetrexed arm)
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 139 participants 80 participants 219 participants
14 5 7
Czechia Number Analyzed 139 participants 80 participants 219 participants
0 1 1
Poland Number Analyzed 139 participants 80 participants 219 participants
1 3 2
Italy Number Analyzed 139 participants 80 participants 219 participants
30 18 31
Israel Number Analyzed 139 participants 80 participants 219 participants
8 3 4
France Number Analyzed 139 participants 80 participants 219 participants
51 31 46
Germany Number Analyzed 139 participants 80 participants 219 participants
2 3 1
Spain Number Analyzed 139 participants 80 participants 219 participants
33 15 26
Hungary Number Analyzed 139 participants 80 participants 219 participants
0 1 1
1.Primary Outcome
Title Overall Survival (OS)
Hide Description OS defined as the time from randomisation to death from any cause in patients with ICI secondary resistance
Time Frame Approx. 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
OS analysis in patients with ICI secondary resistance defined as disease progression after ICI second line > or equal to 12 weeks (n=118) OS analysis in the ITT population with ICI resistance (primary and secondary resistance) is described in statistical analysis 2 (n=219)
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 80 38
Median (95% Confidence Interval)
Unit of Measure: Months
11.1
(8.6 to 13.5)
7.5
(4.7 to 10.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments OS in patients with ICI secondary resistance
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.38 to 0.91
Estimation Comments p=0.017
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments OS in the ITT population with ICI resistance (primary and secondary resistance)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.62 to 1.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Post-Progression Survival
Hide Description Post-progression survival was defined as the time from the earliest date of progression according to RECIST 1.1 until death in patients with ICI secondary resistance
Time Frame approximately 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with ICI secondary resistance defined as disease progression after ICI second line > or equal to 12 weeks (n=118)
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 80 38
Median (95% Confidence Interval)
Unit of Measure: months
7.7
(5.6 to 9.7)
4.6
(3.1 to 5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments Post-progression survival in patients with ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
0.27 to 0.79
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments Post-progression survival in ITT population with ICI resistance (primary and secondary)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0035
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.39 to 0.83
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Time to Worsening ECOG PS
Hide Description Time to Worsening ECOG PS was defined as the time from randomization to the earliest date when ECOG PS was >1 in patients with ICI secondary resistance. Time to worsening ECPG PS was summarized by treatment arm using the Kaplan-Meier method. The median event time for each treatment arm and the corresponding 2-sided 95% confidence interval were provided. By protocol, ECOG PS was not collected when a patient permanenetly discontinued the study treatment. Patients without ECOG PS worsening were censored at the last time when an ECOG value was recorded.
Time Frame Approx. 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with ICI secondary resistance
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 80 38
Median (95% Confidence Interval)
Unit of Measure: months
9.0
(6.3 to 9.9)
3.3
(2.3 to 6.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments Time to worsening ECOG PS >1 in patients with ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
0.23 to 0.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments Time to worsening ECOG PS in the ITT population with ICI resistance (primary and secondary)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.57
Confidence Interval (2-Sided) 95%
0.35 to 0.92
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Changes in Functional Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Hide Description Mean change from baseline to treatment discontinuation in Quality of Life (QoL) score of the following functional subscales analyzed separately: global health status, physical, role, cognitive, emotional and social functioning. Each score range from 0 to 100 after normalisation. Highest scores correspond to a better quality of life. The mean score change was assessed using a mixed-effects model for repeated measures analysis with the patient as the random effect, treatment, visit and treatment-by-visit interaction as explanatory variables and baseline score as covariates. If the mean score change is negative, it means a deterioration of QoL. If the mean score change is positive or 0, it means an improvement or stability of QoL
Time Frame Approx. 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with ICI secondary resistance
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 70 25
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Global Health Status
0.77
(-2.92 to 4.47)
-6.19
(-11.83 to -0.55)
Physical functioning
-2.74
(-6.21 to 0.73)
-8.75
(-14.17 to -3.33)
Role functioning
-5.09
(-10.60 to 0.43)
-16.78
(-25.29 to -8.28)
Emotional functioning
0.50
(-3.29 to 4.28)
-2.75
(-8.63 to 3.12)
Cognitive functioning
-3.20
(-7.18 to 0.78)
-7.64
(-13.86 to -1.43)
Social funtioning
-3.82
(-8.30 to 0.66)
-10.43
(-17.23 to -3.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ C30 Global Health Status in Patients with ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.045
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Physical functioning in patients with ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Role functioning in patients with ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Emotional functioning in patients with ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.36
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Cognitive functioning in patients with ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments QLQ-C30 Social functioning
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.11
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Hide Description Mean change from baseline to treatment discontinuation in Quality of Life (QoL) score of the following symptoms subscales analyzed separately: Fatigue, Constipation, Dyspnea, Nausea and Vomiting, Pain, Insomnia, Appetite loss, Diarrhea, Financial Difficulties. Each score range from 0 to 100 after normalisation. Lowest scores correspond to a better QoL. The mean score change was assessed using a mixed-effects model for repeated measures analysis with the patient as the random effect, treatment, visit and treatment-by-visit interaction as explanatory variables and baseline score as covariates. If the mean score change is negative, it means a deterioration of QoL. If the mean score change is positive or 0, it means an improvement or stability of QoL.
Time Frame Approx. 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
QLQ-C30 Symptoms score changes from baseline in patients with ICI secondary resistance
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 70 25
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Fatigue
4.47
(0.21 to 8.72)
11.95
(5.44 to 18.46)
Constipation
-5.57
(-9.50 to -1.64)
7.84
(1.97 to 13.71)
Dyspnea
3.99
(-1.26 to 9.24)
2.77
(-5.24 to 10.77)
Nausea and Vomiting
-1.49
(-3.83 to 0.84)
1.21
(-2.37 to 4.80)
Pain
4.23
(-0.73 to 9.19)
0.71
(-7.01 to 8.43)
Insomnia
0.42
(-4.25 to 5.08)
-0.29
(-7.24 to 6.65)
Appetite loss
0.08
(-4.79 to 4.94)
-2.33
(-9.66 to 4.99)
Diarrhea
-4.12
(-7.85 to -0.38)
-3.85
(-9.33 to 2.16)
Financial difficulties
2.22
(-2.15 to 6.59)
5.82
(-0.82 to 12.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Fatigue in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Constipation in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.0003
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Dyspnea in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Nausea and Vomiting in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Pain in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Insomnia in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Appetite loss in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Diarrhea in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-C30 Financial difficulties in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.37
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance
Hide Description Mean change from baseline to treatment discontinuation in Quality of Life (QoL) score of the following symptoms subscales analyzed separately: Alopecia, Peripheral Neuropathy, Sore mouth, Dysphagia, Dyspnea, Pain in arm or shoulder, Pain in chest, Pain in other parts, Hemoptysis, Coughing. Each score range from 0 to 100 after normalisation. Lowest scores correspond to a better QoL. The mean score change was assessed using a mixed-effects model for repeated measures analysis with the patient as the random effect, treatment, visit and treatment-by-visit interaction as explanatory variables and baseline score as covariates. If the mean score change is negative, it means a deterioration of QoL. If the mean score change is positive or 0, it means an improvement or stability of QoL.
Time Frame Approx. 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
QLQ-LC 13 symptoms score changes from baseline in patients with ICI secondary resistance
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 70 25
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Alopecia
0.44
(-4.74 to 5.63)
25.83
(17.52 to 34.14)
Peripheral neuropathy
2.65
(-2.33 to 7.63)
13.23
(5.37 to 21.08)
Sore mouth
0.82
(-2.27 to 3.91)
8.52
(3.69 to 13.35)
Dysphagia
0.44
(-2.49 to 3.37)
7.41
(2.85 to 11.98)
Dyspnea
4.99
(0.87 to 9.11)
5.19
(-1.57 to 11.95)
Pain in arm or shoulder
5.00
(0.60 to 9.39)
1.16
(-5.70 to 8.02)
Pain in chest
1.61
(-2.38 to 5.60)
-1.37
(-7.61 to 4.86)
Pain in other parts
8.17
(1.98 to 14.37)
6.56
(-3.04 to 13.17)
Hemoptysis
0.05
(-1.61 to 1.71)
-1.84
(-4.44 to 0.75)
Coughing
-3.62
(-8.85 to 1.61)
-6.67
(-14.92 to 1.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-LC13 Alopecia in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.0001
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-LC 13 Peripheral neuropathy in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-LC13 Sore mouth in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-LC13 Dysphagia in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-LC13 Pain in arm and shoulder
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-LC13 Pain in chest in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-LC13 Pain in other parts
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-LC 13 Hemoptysis in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments QLQ-LC13 Coughing in ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter P Value
Estimated Value 0.54
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Disease Control Rate (DCR) at 6 Months
Hide Description DCR at 6 months defined as the number of patients with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) assessed by investigator per "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions based on CT scan in patients with ICI secondary resistance. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) as >=30% decrease in the sum of the longest diameter of target lesions; Stable disease (SD) defined as neither sufficient shrinkage (compared to baseline) to qualify for CR or PR nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD) (e.g. decrease of the sum of the longest diameters of target lesions <30% or increase up to 20%)
Time Frame Approx. 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
116 out of 118 patients had measurable lesions per RECIST 1.1 at baseline (n=78/80 in OSE2101 arm, 38/38 in docetaxel or pemetrexed arm). One patient had no post-baseline RECIST 1.1 assessement (n=1 in OSE2101 arm).
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 78 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.7
(15.6 to 35.8)
23.7
(11.4 to 40.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments DCR at 6 months in patients with ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.43 to 2.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments DCR at 6 months in ITT patients with ICI resistance (primary and secondary)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.37
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.73
Confidence Interval (2-Sided) 95%
0.36 to 1.46
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Progression Free Survival (PFS) in Patients With ICI Secondary Resistance
Hide Description PFS was defined as the time from randomization to the earliest date of progression assessed by investigator per "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions based on CT scan in patients with ICI secondary resistance. Progressive disease (PD) defined as increase of target lesions >=20% taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest)
Time Frame Approx. 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 80 38
Median (95% Confidence Interval)
Unit of Measure: Months
2.69
(1.61 to 2.79)
2.99
(2.56 to 4.47)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments Median PFS in patients with ICI secondary resistance
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
0.82 to 2.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments Median PFS in ITT patients with ICI resistance (primary and secondary)
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.64
Confidence Interval (2-Sided) 95%
1.18 to 2.28
Estimation Comments [Not Specified]
9.Other Pre-specified Outcome
Title Objective Response Rate (ORR) in ICI Secondary Resistance
Hide Description Objective Response rate (OOR) was defined as number of patients with Complete Response (CR) + Partial Response (PR) assessed by investigator per "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions based on CT scan in patients with ICI secondary resistance. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) as >=30% decrease in the sum of the longest diameter of target lesions. Investigator-assessed ORR was an exploratory endpoint as not relevant as primary, nor secondary endpoints to evaluate a cancer vaccine.
Time Frame Approx. 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
116 out of 118 patients had measurable lesions per RECIST 1.1 at baseline (n=78/80 in OSE2101 arm, 38/38 in docetaxel or pemetrexed arm). One patient had no post-baseline RECIST 1.1 assessement (n=1 in OSE2101 arm)
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 78 38
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
7.7
(2.9 to 16.0)
18.4
(7.7 to 34.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments ORR in ICI secondary resistance
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.33
Confidence Interval (2-Sided) 95%
0.10 to 1.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments ORR in ITT population with ICI resistance (primary and secondary)
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mantel Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
0.08 to 0.59
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Percentage of Patients With Objective Response at 6 Months in ICI Secondary Resistance
Hide Description Duration of Objective Response (OOR) was defined as number of patients with Complete Response (CR) or Partial Response (PR) at 6 months assessed by investigator per "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions based on CT scan in patients with ICI secondary resistance. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) as >=30% decrease in the sum of the longest diameter of target lesions
Time Frame Approx. 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
22 out of 118 patients had an ORR and was analyzed for duration of response (n=7/80 in OSE2101 arm, 15/38 in docetaxel or pemetrexed arm).
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 7 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of with objective response
33.3
(4.6 to 67.6)
26.8
(1.3 to 67.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Duration of response at 6 months in ICI secondary resistance
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.14
Confidence Interval (2-Sided) 95%
0.25 to 5.30
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Duration of Response at 6 months in ITT population with ICI resistance (primary and secondary)
Statistical Test of Hypothesis P-Value 0.57
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.41
Confidence Interval (2-Sided) 95%
0.43 to 4.60
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Time to Next Lung Cancer Therapy in ICI Secondary Resistance
Hide Description Time to next lung cancer therapy was defined as the time from randomisation to the date of initiation of the first lung cancer therapy during the survival follow-up form
Time Frame Approx. 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description:
Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks
Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
Overall Number of Participants Analyzed 80 38
Median (95% Confidence Interval)
Unit of Measure: months
5.4
(4.8 to 7.7)
9.4
(6.3 to 14.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Time to next lung cancer therapy in ICI secondary resistance
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.85
Confidence Interval (2-Sided) 95%
1.03 to 3.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection OSE2101, Docetaxel or Pemetrexed
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Time to next lung cancer therapy in ITT population with ICI resistance (primary and secondary)
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.59
Confidence Interval (2-Sided) 95%
1.07 to 2.36
Estimation Comments [Not Specified]
12.Post-Hoc Outcome
Title Overall Survival Before and During the COVID-19 Period
Hide Description Survival was assessed from date of randomisation to death in the pre COVID-19 pandemic (patients randomised before february 2019 and followed up to 12 months) and during COVID-19 pandemic (patients randomised after february 2019 and followed up to january 2021)
Time Frame Approx. 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients in Pre-COVID-19 Period Patients in the COVID-19 Period
Hide Arm/Group Description:
All patients randomized before february 2019 and followed up to 12 months
All patients randomised after february 2019 and followed up to january 2021
Overall Number of Participants Analyzed 103 116
Median (95% Confidence Interval)
Unit of Measure: months
9.4
(8.0 to 12.2)
8.1
(6.5 to 9.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Patients in Pre-COVID-19 Period, Patients in the COVID-19 Period
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
1.00 to 1.86
Estimation Comments [Not Specified]
Time Frame Adverse Events were collected in each patient from the date of informed consent' signature until 4 weeks after the last dose of study treatment, up to 24 months
Adverse Event Reporting Description A total of 7 patients did not receive the study treatment (n=1 in OSE2101 arm, n=6 in docetaxel or pemetrexed arm).
 
Arm/Group Title OSE2101 Docetaxel or Pemetrexed
Hide Arm/Group Description Subcutaneous injection at 5 mg, 1 ml every 3 weeks for 6 cycles, then every 8 weeks until 1 year of treatment and thereafter every 12 weeks Docetaxel by intravenous infusion over 1 hour at 75 mg/m2 every 3 weeks Pemetrexed by intravenous infusion over 10 minutes at 500 mg/m2 every 3 weeks both with premedication according to international guidelines
All-Cause Mortality
OSE2101 Docetaxel or Pemetrexed
Affected / at Risk (%) Affected / at Risk (%)
Total   116/139 (83.45%)      65/80 (81.25%)    
Hide Serious Adverse Events
OSE2101 Docetaxel or Pemetrexed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/139 (33.81%)      33/80 (41.25%)    
Blood and lymphatic system disorders     
Febrile neutropenia † 1  0/139 (0.00%)  3/80 (3.75%) 
Neutropenia † 1  1/139 (0.72%)  1/80 (1.25%) 
Anemiae † 1  0/139 (0.00%)  1/80 (1.25%) 
thrombocytopenia † 1  0/139 (0.00%)  1/80 (1.25%) 
Cardiac disorders     
Atrial fibrillation † 1  1/139 (0.72%)  0/80 (0.00%) 
Atrial flutter † 1  1/139 (0.72%)  0/80 (0.00%) 
Supraventricular tachycardia † 1  0/139 (0.00%)  1/80 (1.25%) 
acute myocardial infarction † 1  1/139 (0.72%)  0/80 (0.00%) 
Endocrine disorders     
Adrenal insufficiency † 1  1/139 (0.72%)  0/80 (0.00%) 
Gastrointestinal disorders     
Diarrhea † 1  1/139 (0.72%)  2/80 (2.50%) 
Gastrooesophageal reflux disease † 1  0/139 (0.00%)  2/80 (2.50%) 
Intestinal obstruction † 1  2/139 (1.44%)  0/80 (0.00%) 
Subileus † 1  0/139 (0.00%)  1/80 (1.25%) 
Vomiting † 1  0/139 (0.00%)  2/80 (2.50%) 
dysphagia † 1  0/139 (0.00%)  1/80 (1.25%) 
enterocolitis † 1  0/139 (0.00%)  1/80 (1.25%) 
pancreatitis acute † 1  1/139 (0.72%)  0/80 (0.00%) 
General disorders     
General physical health deterioration † 1  4/139 (2.88%)  5/80 (6.25%) 
Influenza like illness † 1  1/139 (0.72%)  0/80 (0.00%) 
Pyrexia † 1  2/139 (1.44%)  1/80 (1.25%) 
gait disturbance † 1  0/139 (0.00%)  1/80 (1.25%) 
non cardiac chest pain † 1  1/139 (0.72%)  0/80 (0.00%) 
Hepatobiliary disorders     
Hypertransaminasaemia † 1  1/139 (0.72%)  0/80 (0.00%) 
Immune system disorders     
Cytokine release syndrome † 1  6/139 (4.32%)  0/80 (0.00%) 
Drug hypersensitivity † 1  1/139 (0.72%)  0/80 (0.00%) 
Giant cell arteritis † 1  1/139 (0.72%)  0/80 (0.00%) 
Infections and infestations     
Bronchitis † 1  0/139 (0.00%)  1/80 (1.25%) 
COVID-19 pneumoniae † 1  1/139 (0.72%)  0/80 (0.00%) 
Endocarditis † 1  0/139 (0.00%)  1/80 (1.25%) 
Pneumocystis jirovecii pneumonia † 1  0/139 (0.00%)  1/80 (1.25%) 
Pneumonia bacterial † 1  1/139 (0.72%)  0/80 (0.00%) 
Respiratory tract infection † 1  2/139 (1.44%)  2/80 (2.50%) 
Sepsis † 1  2/139 (1.44%)  0/80 (0.00%) 
erysipela † 1  0/139 (0.00%)  1/80 (1.25%) 
Pneumonia † 1  0/139 (0.00%)  1/80 (1.25%) 
Injury, poisoning and procedural complications     
Femoral neck fracture † 1  0/139 (0.00%)  1/80 (1.25%) 
Humerus fracture † 1  0/139 (0.00%)  1/80 (1.25%) 
Spinal stenosis † 1  0/139 (0.00%)  1/80 (1.25%) 
femur fracture † 1  1/139 (0.72%)  0/80 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  2/139 (1.44%)  1/80 (1.25%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer † 1  1/139 (0.72%)  0/80 (0.00%) 
Malignant neoplasm progression † 1  3/139 (2.16%)  3/80 (3.75%) 
Brain oedema † 1  1/139 (0.72%)  0/80 (0.00%) 
Cerebrovascular accident † 1  1/139 (0.72%)  0/80 (0.00%) 
Seizure † 1  1/139 (0.72%)  0/80 (0.00%) 
cancer pain † 1  1/139 (0.72%)  0/80 (0.00%) 
metastases to central nervous system † 1  1/139 (0.72%)  0/80 (0.00%) 
paraneoplastic syndrome † 1  0/139 (0.00%)  1/80 (1.25%) 
Nervous system disorders     
Balance disorder † 1  1/139 (0.72%)  0/80 (0.00%) 
aphasia † 1  1/139 (0.72%)  0/80 (0.00%) 
Renal and urinary disorders     
Acute kidney injury † 1  0/139 (0.00%)  2/80 (2.50%) 
Renal haematoma † 1  0/139 (0.00%)  1/80 (1.25%) 
Tubulointerstitial nephritis † 1  1/139 (0.72%)  0/80 (0.00%) 
urinary tract obstruction † 1  0/139 (0.00%)  1/80 (1.25%) 
Respiratory, thoracic and mediastinal disorders     
Bronchial obstruction † 1  1/139 (0.72%)  0/80 (0.00%) 
Chronic obstructive pulmonary disease † 1  0/139 (0.00%)  1/80 (1.25%) 
Dyspnoea † 1  3/139 (2.16%)  2/80 (2.50%) 
Haemoptysis † 1  1/139 (0.72%)  1/80 (1.25%) 
Pleural effusion † 1  1/139 (0.72%)  0/80 (0.00%) 
Pneumonitis † 1  1/139 (0.72%)  0/80 (0.00%) 
Respiratory failure † 1  0/139 (0.00%)  2/80 (2.50%) 
Wheezing † 1  1/139 (0.72%)  0/80 (0.00%) 
acute respiratory distress † 1  0/139 (0.00%)  1/80 (1.25%) 
pulmonary embolism † 1  1/139 (0.72%)  0/80 (0.00%) 
Vascular disorders     
Hypotension † 1  1/139 (0.72%)  0/80 (0.00%)  0
1
Term from vocabulary, MedDRA 20.01
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OSE2101 Docetaxel or Pemetrexed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   125/139 (89.93%)      67/80 (83.75%)    
Blood and lymphatic system disorders     
Anemia † 1  9/139 (6.47%)  13/80 (16.25%) 
Neutropenia † 1  0/139 (0.00%)  13/80 (16.25%) 
Leukopenia † 1  0/139 (0.00%)  4/80 (5.00%) 
Cardiac disorders     
Tachycardia † 1  3/139 (2.16%)  4/80 (5.00%) 
Eye disorders     
lacrimation increased † 1  0/139 (0.00%)  4/80 (5.00%) 
Gastrointestinal disorders     
Nausea † 1  20/139 (14.39%)  14/80 (17.50%) 
Diarrhea † 1  12/139 (8.63%)  21/80 (26.25%) 
Vomiting † 1  14/139 (10.07%)  10/80 (12.50%) 
Constipation † 1  9/139 (6.47%)  11/80 (13.75%) 
Abdominal pain † 1  7/139 (5.04%)  1/80 (1.25%) 
Stomatitis † 1  2/139 (1.44%)  4/80 (5.00%) 
General disorders     
Asthenia † 1  32/139 (23.02%)  32/80 (40.00%) 
Pyrexia † 1  24/139 (17.27%)  9/80 (11.25%) 
Fatique † 1  13/139 (9.35%)  12/80 (15.00%) 
Injection site induration † 1  16/139 (11.51%)  0/80 (0.00%) 
Chest pain † 1  13/139 (9.35%)  2/80 (2.50%) 
Injection site reaction † 1  13/139 (9.35%)  0/80 (0.00%) 
Oedema peripheral † 1  7/139 (5.04%)  7/80 (8.75%) 
Chills † 1  9/139 (6.47%)  0/80 (0.00%) 
Pain † 1  7/139 (5.04%)  5/80 (6.25%) 
Injection site pain † 1  10/139 (7.19%)  0/80 (0.00%) 
Oedema † 1  2/139 (1.44%)  4/80 (5.00%) 
Infections and infestations     
Conjunctivitis † 1  1/139 (0.72%)  5/80 (6.25%) 
Investigations     
Weight decreased † 1  6/139 (4.32%)  8/80 (10.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  28/139 (20.14%)  14/80 (17.50%) 
Hypoalbuminaemia † 1  5/139 (3.60%)  5/80 (6.25%) 
Hyperglycaemia † 1  1/139 (0.72%)  4/80 (5.00%) 
Hypokaliaemia † 1  1/139 (0.72%)  4/80 (5.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  20/139 (14.39%)  6/80 (7.50%) 
Back pain † 1  13/139 (9.35%)  8/80 (10.00%) 
Myalgia † 1  7/139 (5.04%)  4/80 (5.00%) 
Pain in extremity † 1  4/139 (2.88%)  4/80 (5.00%) 
Nervous system disorders     
Headache † 1  7/139 (5.04%)  2/80 (2.50%) 
Neuropathy peripheral † 1  0/139 (0.00%)  7/80 (8.75%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea † 1  20/139 (14.39%)  14/80 (17.50%) 
Cough † 1  13/139 (9.35%)  8/80 (10.00%) 
Haemoptysis † 1  5/139 (3.60%)  4/80 (5.00%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  1/139 (0.72%)  21/80 (26.25%) 
Nail toxicity † 1  0/139 (0.00%)  4/80 (5.00%) 
Vascular disorders     
Hypotension † 1  3/139 (2.16%)  4/80 (5.00%) 
1
Term from vocabulary, MedDRA 20.01
†
Indicates events were collected by systematic assessment
In April 2020 at time of planned interim analysis, decision was taken to prematurely stop the accrual due to COVID-19. Early termination led to small numbers of subject analyzed. The statistical plan was revised to propose the primary efficacy analysis in subgroup of patients with ICI secondary resistance (defined as progression after ICI second line >= to 12 weeks from stratification criteria based on biological and clinical rationale).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Chief Medical Officer Immuno-Oncology
Organization: OSE Immunotherapeutics
Phone: +33 2 28 29 10 10
EMail: contact@ose-immuno.com
Publications of Results:
Besse B, Felip E, Garcia Campelo R, Cobo M, Mascaux C, Madroszyk A, Cappuzzo F, Hilgers W, Romano G, Denis F, Viteri S, Debieuvre D, Galetta D, Baldini E, Razaq M, Robinet G, Maio M, Delmonte A, Roch B, Masson P, Schuette W, Zer A, Remon J, Costantini D, Vasseur B, Dziadziuszko R, Giaccone G; ATALANTE-1 study group. Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1. Ann Oncol. 2023 Oct;34(10):920-933. doi: 10.1016/j.annonc.2023.07.006. Epub 2023 Sep 11.
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Responsible Party: OSE Immunotherapeutics
ClinicalTrials.gov Identifier: NCT02654587    
Other Study ID Numbers: OSE2101C301
2015-003183-36 ( EudraCT Number )
First Submitted: January 8, 2016
First Posted: January 13, 2016
Results First Submitted: October 30, 2023
Results First Posted: February 2, 2024
Last Update Posted: February 2, 2024