Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
CheckMate 9LA
Clinical summary
Summary
In this trial, participants will be randomized into one of two modules. In Module A, participants will receive specified doses of immunotherapy (Ipilimumab and Nivolumab) and chemotherapy (Carboplatin, Paclitaxel, Pemetrexed and Cisplatin)on specified days. In Module B, participants will only receive specified doses of chemotherapy (Carboplatin, Paclitaxel, Pemetrexed and Cisplatin)on specified days.
Conditions
This trial is treating people with Non-Small Cell (NSC) Lung Cancer
Eligibility
Inclusion
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- 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
- 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
Inclusion
- You have been diagnosed with cancer, but have not received any treatment.
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bristol-Myers Squibb (BMS)
Scientific Title
A 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
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