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

Study Overview
=================
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.

Official Title
-----------------
A Phase 3 Open Label, Randomized Study of BMS-986205 Combined With Nivolumab With or Without Chemotherapy Versus Chemotherapy in Participants With Previously Untreated Stage IV or Recurrent Non-Small Cell Lung Cancer

Conditions
-----------------
Lung Cancer, Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: BMS-986205
* Biological: Nivolumab
* Drug: Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>BMS-986205 and Nivolumab administered in combination | Drug: BMS-986205<br>* Administered orally daily, 100 mg<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;|
| Experimental: Arm B<br>BMS-986205 and Nivolumab administered in combination with chemotherapy | Drug: BMS-986205<br>* Administered orally daily, 100 mg<br>Biological: Nivolumab<br>* Specified dose on specified days<br>* Other names: BMS-936558;Drug: Chemotherapy<br>* Platinum-based doublet chemotherapy<br>|
| Active Comparator: Arm C<br>Chemotherapy administered alone | Drug: Chemotherapy<br>* Platinum-based doublet chemotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 adverse events (AE) |  | Approximately 5 years | 
| Number of treatment-related serious adverse events |  | Approximately 5 years |