A 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)

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 2

Conditions: Metastatic Non-small Cell Lung Cancer; Non-small Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer

Treatments: Drug: Nab-Paclitaxel; Drug: Cisplatin; Biological: Relatlimab; Drug: Pemetrexed; Biological: Nivolumab; Drug: Paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04623775

CA224-104

2020-004026-31 (EudraCT Number)

U1111-1256-8115 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

Enrollment: 468 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization.
• Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria.
• No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease.

Exclusion Criteria

• Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy.
• Untreated CNS metastases.
• Leptomeningeal metastases (carcinomatous meningitis).
• Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease).
• Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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468 participants in 4 patient groups

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Experimental group

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Biological: Nivolumab

Drug: Pemetrexed

Biological: Relatlimab

Drug: Cisplatin

Drug: Nab-Paclitaxel

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Experimental group

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Biological: Nivolumab

Drug: Pemetrexed

Biological: Relatlimab

Drug: Cisplatin

Drug: Nab-Paclitaxel

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Experimental group

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Biological: Nivolumab

Drug: Pemetrexed

Biological: Relatlimab

Drug: Cisplatin

Part 2: Arm D (Nivolumab + PDCT)

Active Comparator group

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Biological: Nivolumab

Drug: Pemetrexed

Drug: Cisplatin