Study of OSE2101 Versus Standard Treatment as 2nd or 3rd Line in HLA-A2 Positive Patients With Advanced NSCLC After Failure of Immune Checkpoint Inhibitor (ATALANTE 1)
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|ClinicalTrials.gov Identifier: NCT02654587|
Recruitment Status : Unknown
Verified March 2021 by OSE Immunotherapeutics.
Recruitment status was: Active, not recruiting
First Posted : January 13, 2016
Last Update Posted : March 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Drug: OSE2101 Drug: Docetaxel Drug: Pemetrexed||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||363 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Step 1 primary objective: Overall Survival rate (approx. 100 patients) / Step 2 primary objective: Overall Survival (approx. 363 patients in total, number to be reassessed based on the step 1 results)|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Parallel Group Phase III Trial of OSE2101 as 2nd or 3rd Line Compared With Standard Treatment (Docetaxel or Pemetrexed) in HLA-A2 Positive Patients With Advanced Non-Small-Cell Lung Cancer With Progressive Disease After Last Treatment With Immune Checkpoint Inhibitors (ICI). (OSE2101C301)|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||December 2021|
OSE2101 will be administered as a 1 mL-subcutaneous injection on Day 1 every three weeks for six cycles, then every eight weeks for the remainder of year one and finally every twelve weeks beyond year one until unequivocal RECIST 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal. Should pseudo progression or delayed response to treatment suspected in arm A, investigator may continue treatment beyond the time of RECIST-defined progression, if the patient is perceived to be experiencing clinical benefit. OSE2101 dose will be 5 mg of peptide (0.5 mg for each peptide).
Active Comparator: Docetaxel or Pemetrexed
Patients receiving docetaxel: Docetaxel 75 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of a 21-day cycle.
Patients receiving pemetrexed: Pemetrexed, 500 mg/m2, will be administered by intravenous infusion over 10 minutes on Day 1 of a 21-day cycle.
Docetaxel and pemetrexed will be continued until unequivocal RECIST 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal.
Other Name: Taxotere
Other Name: Alimta
- Overall Survival time (OS) [ Time Frame: Approx. 24 months ]
- In Step 1: OS rate at 12 months in experimental Arm A (OSE2101) in 84 evaluable patients exposed to OSE2101
- In Step 2: comparison of OS between experimental Arm A (OSE2101) and control Arm B (docetaxel or pemetrexed) when 278 events observed
- Disease Control Rate (DCR) at 6 months [ Time Frame: 6 months ]
- QLQ-C30 (EORTC QLQ questionnaire): "Global health status/QoL" score based on questions 29 [ Time Frame: Approx. 24 months ]
- QLQ-LC13 (lung cancer module from EORTC QLQ questionnaire): time to 1st ≥ 10-point deterioration in (question 40), dyspnea (questions 33, 34, 35) or cough (question 31) [ Time Frame: Approx. 24 months ]
- Progression Free Survival (PFS) [ Time Frame: Approx. 24 months ]
- Objective Response Rate (ORR) (in Step 1 only) [ Time Frame: Approx. 24 months ]
- DCR at 12 months (in Step 1 only) [ Time Frame: Approx. 24 months ]
- Duration of Response (DR) (in Step 1 only) [ Time Frame: Approx. 24 months ]
- Safety and tolerability profile compared to the control group [ Time Frame: Approx. 24 months ]
- Objective Response Rate (ORR) (In Step 2 only) [ Time Frame: Approx. 24 months ]
- Disease Control Rate (DCR) at 12 months (In Step 2 only) [ Time Frame: 12 months ]
- Duration of Response (DR) (In Step 2 only) [ Time Frame: Approx. 24 months ]
- Time to deterioration (TTD) [ Time Frame: Approx. 24 months ]
- Time to next lung cancer therapy [ Time Frame: Approx. 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02654587