An Immuno-Therapy Study of Experimental Medication BMS-986205 Given With Nivolumab With or Without Chemotherapy Compared to Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer
Phase 3
Withdrawn
- Conditions
- Non-Small Cell Lung CancerLung Cancer
- Interventions
- Registration Number
- NCT03417037
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This is a study of experimental medication BMS-986205 given with Nivolumab with or without chemotherapy compared to chemotherapy in participants with previously untreated stage IV or recurrent non-small cell lung cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Histologically confirmed stage IV NSCLC per the 8th IASLC of squamous or nonsquamous histology
- Locally advanced disease with recurrence after chemoradiation therapy (stage IIIB disease, specifically refers to patients with no curative treatment options)
- No prior systemic anti-cancer therapy (including EGFR and ALK/ROS1 inhibitors) given as primary therapy for advanced or metastatic disease
- Participants must have biomarker test results available for randomization
- ECOG Performance Status of ≤ 1
- Measurable disease by CT or MRI per RECIST 1.1 criteria
Exclusion Criteria
- Participants with known sensitizing EGFR mutations or known ALK/ROS1 rearrangements
- Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- Participants with an active, known or suspected autoimmune disease [Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll]
- 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 defined inclusion/exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A BMS-986205 BMS-986205 and Nivolumab administered in combination Arm B Chemotherapy BMS-986205 and Nivolumab administered in combination with chemotherapy Arm A Nivolumab BMS-986205 and Nivolumab administered in combination Arm B BMS-986205 BMS-986205 and Nivolumab administered in combination with chemotherapy Arm B Nivolumab BMS-986205 and Nivolumab administered in combination with chemotherapy Arm C Chemotherapy Chemotherapy administered alone
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) measured by number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group 24 months Progression free survival (PFS) measured by the time between the date of randomization and the first date of documented progression, as determined by the Blinded Independent Central Review, or death, due to any cause, whichever occurs first 34 months
- Secondary Outcome Measures
Name Time Method Number of treatment-related adverse events (AE) Approximately 5 years Overall survival (OS) measured by the time between the date of randomization and the date of death due to any cause Approximately 5 years Number of treatment-related serious adverse events Approximately 5 years
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie BMS-986205's synergy with nivolumab in PD-1/PD-L1 pathway modulation for NSCLC?
How does the BMS-986205+nivolumab combination compare to standard platinum-based chemotherapy in previously untreated stage IV NSCLC efficacy?
Which PD-L1 expression levels or TMB biomarkers best predict response to BMS-986205+nivolumab versus chemotherapy in NSCLC?
What are the most common adverse events associated with BMS-986205+nivolumab combination therapy in NSCLC patients?
How does BMS-986205's mechanism compare to other LAG-3 inhibitors like relatlimab in combination with PD-1/PD-L1 blockade for NSCLC?
Trial Locations
- Locations (1)
Local Institution
🇹🇷Istanbul, Turkey
Local Institution🇹🇷Istanbul, Turkey