A Phase 2 Randomized Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
- Conditions
- NSCLC10038666lung cancer
- Registration Number
- NL-OMON56032
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 13
• Males and females; >= 18 years of age or local age of majority.
•Histologically confirmed metastatic NSCLC of squamous (SQ) or non squamous
(NSQ) histology with Stage IV or recurrent disease following multi-modal
therapy for locally advanced disease.
•Measurable disease by computed tomography or magnetic resonance imaging per
Response
•Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria; radiographic tumor
assessment performed within 28 days before randomization.
•No prior systemic anti-cancer treatment given as primary therapy for advanced
or metastatic disease.
•ECOG PS of less than or equal to 1 at screening and confirmed prior to
randomization.
•Participants must have a life expectancy of at least 3 months at the time of
first dose.
•A formalin-fixed paraffin-embedded tissue block containing enough tissue to
cut 20 sections (preferred; please see study Laboratory Manual for specific
guidance) or a minimum of 20 unstained slides of tumor tissue from core biopsy,
punch biopsy, excisional biopsy, or surgical specimen obtained during screening
or prior to enrollment (within 3 months of enrollment if stored at 2-8°C or
within 2 months of enrollment if stored at ambient
temperature and with no intervening systemic anti-cancer treatment between time
of acquisition and enrollment) must be sent to the central laboratory.
•Participants must have PD-L1 immunohistochemistry (IHC) results from a central
laboratory during the screening period prior to randomization.
•Women who are pregnant or breastfeeding.
•Participants with EGFR, ALK, or ROS-1 mutations which are sensitive to
available targeted inhibitor therapy. All participants with NSQ histology must
have been tested for EGFR, ALK, or ROS-1 mutation status. Participants with NSQ
histology and unknown EGFR, ALK, or ROS-1
status are excluded.
•Participants with known BRAFV600E mutations that are sensitive to available
targeted inhibitor therapy. Participants with unknown or indeterminate BRAF
mutation status are eligible.
•Participants with untreated central nervous system metastases.
•Participants with leptomeningeal metastases (carcinomatous meningitis).
•Concurrent malignancy requiring treatment.
•Participants with an active, known, or suspected autoimmune disease.
•Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-LAG-3, or
anti-CTLA-4 antibody, or any other antibody or drug specifically targeting
T-cell co-stimulation or checkpoint pathways.
•Participants with history of myocarditis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part 1.<br /><br>- TRAEs leading to discontinuation within 12 weeks after the first dose<br /><br><br /><br><br /><br>Part 2:<br /><br>- ORR per RECIST v1.1 by BICR</p><br>
- Secondary Outcome Measures
Name Time Method <p>Part 1:<br /><br>- Incidence of TRAEs leading to discontinuation, AEs, SAEs, and select AEs<br /><br><br /><br>Part 2:<br /><br>- DoR per RECIST v1.1 by BICR, including DoR at 6, 12 and 18 months<br /><br>- ORR and PFS per RECIST v1.1 by BICR<br /><br>- Incidence of AEs, SAEs, TRAEs, IMAEs and select AEs</p><br>