Lung Cancer, Non-Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGBMS-986205
Administered orally daily, 100 mg
BIOLOGICALNivolumab
Specified dose on specified days
DRUGChemotherapy
Platinum-based doublet chemotherapy
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Australia, Austria, Brazil, Canada, Czechia, France, Germany, Greece, Italy, Japan, Mexico, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United States
Outcome results
None listed