Completed

CheckMate 9LANivolumab and Ipilimumab with Chemotherapy for Stage IV NSCLC

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What is being tested

Ipilimumab

+ Nivolumab

+ Carboplatin

BiologicalDrug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2017
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 24, 2017

Actual date on which the first participant was enrolled.

This study focuses on finding out if a combination of two drugs, Nivolumab and Ipilimumab, along with chemotherapy, can improve treatment outcomes for individuals with stage IV non-small cell lung cancer (NSCLC) compared to using chemotherapy alone. This study targets patients who are receiving their first treatment for this advanced stage of lung cancer. The goal is to see if this combination can enhance survival rates, offering a potentially more effective treatment option for those dealing with this challenging condition. Participants in the study will be randomly divided into two groups: one receiving the combination of Nivolumab and Ipilimumab with chemotherapy, and the other receiving only chemotherapy. The effectiveness of the treatments will be measured by monitoring the overall survival of participants, which means tracking how long they live after starting the treatment. Follow-ups will happen every three months to see how long participants are living after the treatment ends. This research aims to provide valuable information that could lead to better treatment strategies for advanced lung cancer patients.

Official TitleA Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
NCT03215706
Principal SponsorBristol-Myers Squibb
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

719 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Chemotherapy/Biologics combined

Group II

Active Comparator
Chemotherapy Combination

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 116 locations

Suspended

Local Institution - 0074

Magdeburg, GermanyOpen Local Institution - 0074 in Google Maps
Suspended

Local Institution - 0052

Madrid, Spain
Suspended

Local Institution - 0055

Málaga, Spain
Suspended

Local Institution - 0056

Valencia, Spain
Completed116 Study Centers