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Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)

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ClinicalTrials.gov Identifier: NCT04484142
Recruitment Status : Active, not recruiting
First Posted : July 23, 2020
Results First Posted : April 3, 2024
Last Update Posted : April 9, 2024
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Intervention Drug: DS-1062a
Enrollment 137
Recruitment Details A total of 137 participants who met all inclusion criteria and no exclusion criteria were enrolled to receive Dato-DXd treatment in 50 clinical sites, North America= 15, Europe= 14, Asia Pacific= 21.
Pre-assignment Details  
Arm/Group Title Dato DXd 6.0 mg/kg Q3W
Hide Arm/Group Description Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Period Title: Overall Study
Started 137
Completed 20
Not Completed 117
Reason Not Completed
Adverse Event             13
Progressive Disease             87
Clinical Progression             10
Withdrawal by Subject             6
Physician Decision             1
Arm/Group Title Dato DXd 6.0 mg/kg Q3W
Hide Arm/Group Description Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Overall Number of Baseline Participants 137
Hide Baseline Analysis Population Description
The baseline demographic characteristics were assessed in the Full Analysis Set, which includes all subjects who received at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
<=18 years
0
   0.0%
Between 18 and 65 years
91
  66.4%
>=65 years
46
  33.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 137 participants
59.5  (11.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
Female
83
  60.6%
Male
54
  39.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 137 participants
American Indian or Alaska Native
0
   0.0%
Asian
78
  56.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
43
  31.4%
More than one race
15
  10.9%
Unknown or Not Reported
1
   0.7%
1.Primary Outcome
Title Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR)
Hide Description ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time Frame From baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome Measure was assessed in the Full Analysis Set, which includes all subjects who received at least 1 dose of study drug.
Arm/Group Title Dato DXd 6.0 mg/kg Q3W
Hide Arm/Group Description:
Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Overall Number of Participants Analyzed 137
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.8
(27.8 to 44.4)
2.Secondary Outcome
Title Duration of Response (DOR)
Hide Description [Not Specified]
Time Frame From baseline up to approximately 24 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description [Not Specified]
Time Frame From baseline up to approximately 24 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame From baseline up to approximately 24 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Pharmacokinetic Parameter Maximum Concentration (Cmax)
Hide Description [Not Specified]
Time Frame From baseline up to approximately 24 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
Hide Description [Not Specified]
Time Frame From baseline up to approximately 24 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC)
Hide Description [Not Specified]
Time Frame From baseline up to approximately 24 months
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Participants Who Reported Treatment-emergent Adverse Events (TEAE)
Hide Description [Not Specified]
Time Frame From baseline up to approximately 24 months
Outcome Measure Data Not Reported
Time Frame Adverse events (AE) were collected from the date of first treatment, up to 24 months.
Adverse Event Reporting Description A treatment-emergent adverse event (TEAE) is defined as an adverse event with a start or worsening date on or after the start of study treatment until 35 days since the last dose of study treatment.
 
Arm/Group Title Dato DXd 6.0 mg/kg Q3W
Hide Arm/Group Description Participants received an intravenous (IV) infusion of Dato DXd administered at a dose of 6.0 mg/kg every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
All-Cause Mortality
Dato DXd 6.0 mg/kg Q3W
Affected / at Risk (%)
Total   68/137 (49.64%)    
Hide Serious Adverse Events
Dato DXd 6.0 mg/kg Q3W
Affected / at Risk (%) # Events
Total   34/137 (24.82%)    
Eye disorders   
Cataract † 1  1/137 (0.73%)  2
Glaucoma † 2  1/137 (0.73%)  1
Gastrointestinal disorders   
Abdominal pain upper † 2  1/137 (0.73%)  1
Dysphagia † 2  1/137 (0.73%)  1
Gastric perforation † 2  1/137 (0.73%)  1
Stomatitis † 2  1/137 (0.73%)  1
Vomiting † 2  1/137 (0.73%)  2
General disorders   
Fatigue † 2  1/137 (0.73%)  1
Hepatobiliary disorders   
Hepatic function abnormal † 2  1/137 (0.73%)  1
Immune system disorders   
Hypersensitivity † 2  1/137 (0.73%)  1
Infections and infestations   
COVID-19 † 2  2/137 (1.46%)  2
COVID-19 pneumonia † 2  1/137 (0.73%)  1
Herpes zoster † 2  1/137 (0.73%)  1
Influenza † 2  1/137 (0.73%)  1
Septic shock † 2  1/137 (0.73%)  1
Investigations   
Ejection fraction decreased † 2  1/137 (0.73%)  1
Oxygen saturation decreased † 2  1/137 (0.73%)  1
Musculoskeletal and connective tissue disorders   
Soft tissue swelling † 2  1/137 (0.73%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Non-small cell lung cancer † 2  1/137 (0.73%)  1
Tumour associated fever † 2  1/137 (0.73%)  1
Nervous system disorders   
Aphasia † 2  1/137 (0.73%)  1
Cerebral infarction † 2  1/137 (0.73%)  1
Dizziness † 2  1/137 (0.73%)  1
Headache † 2  1/137 (0.73%)  1
Hypoxic-ischaemic encephalopathy † 2  1/137 (0.73%)  1
Spinal cord compression † 2  1/137 (0.73%)  1
Psychiatric disorders   
Confusional state † 2  1/137 (0.73%)  1
Mental status changes † 2  1/137 (0.73%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea † 2  4/137 (2.92%)  4
Pneumonitis † 2  3/137 (2.19%)  4
Bronchial obstruction † 2  1/137 (0.73%)  1
Pharyngeal inflammation † 2  1/137 (0.73%)  1
Vascular disorders   
Deep vein thrombosis † 2  1/137 (0.73%)  1
1
Term from vocabulary, MedDRA 25.1
2
Term from vocabulary, MedDRA25.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dato DXd 6.0 mg/kg Q3W
Affected / at Risk (%) # Events
Total   135/137 (98.54%)    
Blood and lymphatic system disorders   
Anaemia † 1  21/137 (15.33%)  24
Blood alkaline phosphatase increased † 1  7/137 (5.11%)  8
Eye disorders   
Dry eye † 1  15/137 (10.95%)  16
Vision blurred † 1  12/137 (8.76%)  12
Keratitis † 1  7/137 (5.11%)  7
Gastrointestinal disorders   
Nausea † 1  82/137 (59.85%)  117
Stomatitis † 1  79/137 (57.66%)  89
Constipation † 1  43/137 (31.39%)  47
Vomiting † 1  31/137 (22.63%)  41
Diarrhoea † 1  17/137 (12.41%)  19
General disorders   
Fatigue † 1  34/137 (24.82%)  40
Asthenia † 1  21/137 (15.33%)  35
Pyrexia † 1  14/137 (10.22%)  17
Malaise † 1  11/137 (8.03%)  13
Oedema peripheral † 1  7/137 (5.11%)  7
Infections and infestations   
COVID-19 † 1  20/137 (14.60%)  20
Injury, poisoning and procedural complications   
Infusion related reaction † 1  9/137 (6.57%)  9
Investigations   
Weight decreased † 1  14/137 (10.22%)  14
Amylase increased † 1  12/137 (8.76%)  17
Aspartate aminotransferase increased † 1  9/137 (6.57%)  9
Blood creatinine increased † 1  9/137 (6.57%)  12
White blood cell count decreased † 1  9/137 (6.57%)  13
Alanine aminotransferase increased † 1  8/137 (5.84%)  10
Neutrophil count decreased † 1  8/137 (5.84%)  10
Metabolism and nutrition disorders   
Decreased appetite † 1  37/137 (27.01%)  44
Hypokalaemia † 1  9/137 (6.57%)  10
Hypoalbuminaemia † 1  8/137 (5.84%)  9
Hyponatraemia † 1  8/137 (5.84%)  11
Musculoskeletal and connective tissue disorders   
Back pain † 1  8/137 (5.84%)  8
Myalgia † 1  7/137 (5.11%)  7
Nervous system disorders   
Headache † 1  14/137 (10.22%)  14
Dizziness † 1  9/137 (6.57%)  9
Dysgeusia † 1  8/137 (5.84%)  8
Respiratory, thoracic and mediastinal disorders   
Cough † 1  20/137 (14.60%)  21
Dyspnoea † 1  15/137 (10.95%)  16
Oropharyngeal pain † 1  8/137 (5.84%)  8
Skin and subcutaneous tissue disorders   
Alopecia † 1  70/137 (51.09%)  71
Rash † 1  21/137 (15.33%)  27
Pruritus † 1  14/137 (10.22%)  14
Rash maculo-papular † 1  10/137 (7.30%)  11
1
Term from vocabulary, MedDRA25.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Contact for Clinical Trial Information
Organization: Daiichi Sanyko, Inc
Phone: 908-992-6400
EMail: CTRinfo@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT04484142    
Other Study ID Numbers: DS1062-A-U202
2020-002774-27 ( EudraCT Number )
First Submitted: July 20, 2020
First Posted: July 23, 2020
Results First Submitted: March 8, 2024
Results First Posted: April 3, 2024
Last Update Posted: April 9, 2024