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Withdrawn

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.

Recruitment & Eligibility

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

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

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