NCT03215706CompletedPhase 3
A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
Bristol-Myers Squibb116 sites in 8 countries719 target enrollmentStarted: August 24, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 719
- Locations
- 116
- Primary Endpoint
- Overall Survival (OS)
Study Overview
Brief Summary
The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
- •Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
- •Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period
Exclusion Criteria
- •Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
- •Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
- •Participants with untreated CNS metastases are excluded. Participants are eligible if CNS metastases are adequately treated 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 first treatment
- •Other protocol inclusion/exclusion criteria may apply
Arms & Interventions
Module B
Active Comparator
Chemotherapy Combination
Intervention: Paclitaxel (Drug)
Module B
Active Comparator
Chemotherapy Combination
Intervention: Pemetrexed (Drug)
Module A
Experimental
Chemotherapy/Biologics combined
Intervention: Ipilimumab (Biological)
Module A
Experimental
Chemotherapy/Biologics combined
Intervention: Nivolumab (Biological)
Module A
Experimental
Chemotherapy/Biologics combined
Intervention: Carboplatin (Drug)
Module A
Experimental
Chemotherapy/Biologics combined
Intervention: Paclitaxel (Drug)
Module A
Experimental
Chemotherapy/Biologics combined
Intervention: Pemetrexed (Drug)
Module A
Experimental
Chemotherapy/Biologics combined
Intervention: Cisplatin (Drug)
Module B
Active Comparator
Chemotherapy Combination
Intervention: Carboplatin (Drug)
Module B
Active Comparator
Chemotherapy Combination
Intervention: Cisplatin (Drug)
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: From date of randomization to date of death (assessed up to October 2019, approximately 23 months)
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
Secondary Outcomes
- Progression Free Survival (PFS) by BICR(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- Objective Response Rate (ORR) by BICR(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- Duration of Response (DoR)(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- Time to Response (TTR)(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- PFS by BICR by PD-L1 Tumor Cell Expression(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- OS by PD-L1 Tumor Cell Expression(From date of randomization to date of death (assessed up to October 2024, approximately 72 months))
- PFS by BICR by Tumor Mutational Burden(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- ORR by BICR by Tumor Mutational Burden(From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months))
- OS by Tumor Mutational Burden(From date of randomization to date of death (assessed up to October 2024, approximately 72 months))
Investigators
Study Sites (116)
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