A Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy in Participants with Stage IV or Recurrent NSCLC

Phase 1

• Conditions: on Small Cell Lung Cancer; MedDRA version: 20.1Level: LLTClassification code 10025048Term: Lung cancer non-small cell recurrentSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IVSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-004026-31-DE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-23
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

•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) 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 156
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 364

Exclusion Criteria

•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 clinical trial of medicinal product
• Study Design: Not specified