A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC (CheckMate 9LA)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Biological: Ipilimumab; Biological: Nivolumab; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03215706

CA209-9LA

2017-001195-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

Enrollment: 719 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria:

• Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
• Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
• Measurable disease by CT or MRI per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) criteria
• Participants must have PD-L1 IHC testing with results performed by a central laboratory during the screening period

Exclusion Criteria:

• Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded
• Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded
• 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 inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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719 participants in 2 patient groups

Module A

Experimental group

Description:

Chemotherapy/Biologics combined

Treatment:

Drug: Carboplatin

Drug: Cisplatin

Drug: Pemetrexed

Drug: Paclitaxel

Biological: Nivolumab

Biological: Ipilimumab

Module B

Active Comparator group

Description:

Chemotherapy Combination

Treatment:

Drug: Carboplatin

Drug: Cisplatin

Drug: Pemetrexed

Drug: Paclitaxel