Description:
The main purpose of this study is to determine whether nivolumab + chemotherapy is effective
as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed
first line (1L) or second-line (2L) EGFR TKI therapy.
Title
- Brief Title: A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy
- Official Title: Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy
Clinical Trial IDs
- ORG STUDY ID:
CA209-722
- SECONDARY ID:
2017-002672-38
- NCT ID:
NCT02864251
Conditions
- Non-Small-Cell Lung Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | Opdivo, BMS-936558 | Nivolumab + Ipilimumab |
Ipilimumab | Yervoy, BMS-734016 | Nivolumab + Ipilimumab |
Pemetrexed | | Nivolumab+Platinum doublet chemotherapy |
Cisplatin | | Nivolumab+Platinum doublet chemotherapy |
Carboplatin | | Nivolumab+Platinum doublet chemotherapy |
Purpose
The main purpose of this study is to determine whether nivolumab + chemotherapy is effective
as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed
first line (1L) or second-line (2L) EGFR TKI therapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Nivolumab+Platinum doublet chemotherapy | Experimental | | - Nivolumab
- Pemetrexed
- Cisplatin
- Carboplatin
|
Nivolumab + Ipilimumab | Experimental | Enrollment is closed for this arm | |
Platinum doublet chemotherapy | Active Comparator | | - Pemetrexed
- Cisplatin
- Carboplatin
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Confirmed stage IV or recurrent EGFR mutated NSCLC with disease progression on one or
two prior lines of treatment with EGFR TKIs (allowed TKIs must be approved by the
local health authority, including but not limited to erlotinib, gefitinib, afatinib,
dacomitinib and osimertinib).
- No evidence of exon 20 T790M mutation obtained at progression on prior first- or
second-generation EGFR TKI therapy.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors version
1.1 (RECIST 1.1)
- Available tumor sample for Programmed death-ligand 1 (PD-L1) immunohistochemical
(IHC). For participants who were treated with osimertinib, T790M testing is not
required.
- Participants are eligible if central nervous system (CNS) metastases are considered to
be adequately controlled/treated before or during the screening period and
participants are neurologically returned to baseline (except for residual signs or
symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In
addition, participants must be either off corticosteroids, or on a stable or
decreasing dose of ≤10 mg daily prednisone (or equivalent) for at least 2 weeks prior
to randomization). Participants with asymptomatic CNS metastasis are eligible.
- Eastern Cooperative Group (ECOG) Performance Status 0-1
- Life expectancy is at least 3 months
Exclusion Criteria:
- Known EGFR mutation, T790M positive who failed 1L first- or second-generation TKI
should receive osimertinib first as the standard of care (SOC). These participants are
only eligible if they fail osimertinib as 2L.
- who have progressed within 3 months of the first dose of 1L or 2L EGFR TKI.
- Carcinomatous meningitis
- Active, known or suspected autoimmune disease are excluded
- ALK translocation
- Known SCLC transformation
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
antibody, or any other antibody or drug specifically targeting T-cell co-stimulation
or checkpoint pathways
Other protocol defined inclusion/exclusion criteria apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression free survival (PFS) assessed by blinded independent central review (BICR) |
Time Frame: | up to 47 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall survival (OS) |
Time Frame: | Up to 74 months |
Safety Issue: | |
Description: | |
Measure: | Objective response rate (ORR) per response evaluation criteria in solid tumors (RECIST) 1.1 by BICR |
Time Frame: | Up to 47 months |
Safety Issue: | |
Description: | |
Measure: | Duration of response (DOR) by BICR |
Time Frame: | Up to 47 months |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS) rate by BICR |
Time Frame: | Up to 47 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
April 5, 2021