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Closed (no longer recruiting)Last updated: 30 January 2024

CheckMate 9LA: This phase III trial is trying to determine whether treatment with immunotherapy (Nivolumab Plus Ipilimumab) and chemotherapy is better than chemotherapy alone in treating patients with Stage 4 Non-Small Cell (NSC) Lung CancerA 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

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 patients with Non-Small Cell (NSC) Lung Cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

Trial Acronym

CheckMate 9LA

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

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.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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