CheckMate 9LANivolumab and Ipilimumab with Chemotherapy for Stage IV NSCLC
Ipilimumab
+ Nivolumab
+ Carboplatin
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.719 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy 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
Local Institution - 0052
Madrid, SpainLocal Institution - 0055
Málaga, SpainLocal Institution - 0056
Valencia, Spain