Phase 3
Completed N=719
A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC
Source: ClinicalTrials.gov NCT03215706 ↗Enrolled (actual)
719
Serious AEs
64.5%
Results posted
Sep 2020
Primary outcomePrimary: Overall Survival (OS) — 14.13; 10.74 Months — p=0.0006
◆ Published Evidence
Highly cited
1,356citations · ~271 / year
First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial.
Summary
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
Linked Publications (3)
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First-line nivolumab plus ipilimumab combined with two cycles of chemotherapy in patients with non-small-cell lung cancer (CheckMate 9LA): an international, randomised, open-label, phase 3 trial.
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Five-year outcomes with first-line nivolumab plus ipilimumab with 2 cycles of chemotherapy versus 4 cycles of chemotherapy alone in patients with metastatic non-small cell lung cancer in the randomized CheckMate 9LA trial.
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Long-Term Survival Outcomes With First-Line Nivolumab Plus Ipilimumab-Based Treatment in Patients With Metastatic NSCLC and Tumor Programmed Death-Ligand 1 Lower Than 1%: A Pooled Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
15.80; 10.96 | — |
| SECONDARY Progression Free Survival (PFS) by BICR |
6.74; 5.26 | — |
| SECONDARY Objective Response Rate (ORR) by BICR |
38.0; 25.1 | — |
| SECONDARY Duration of Response (DoR) |
13.01; 5.59 | — |
| SECONDARY Time to Response (TTR) |
2.53; 1.58 | — |
| SECONDARY Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression |
42.6; 27.5; 31.1; 20.2; 36.4; 32.0 | — |
| SECONDARY PFS by BICR by PD-L1 Tumor Cell Expression |
5.78; 4.96; 6.87; 4.70; 6.74; 5.29 | — |
| SECONDARY OS by PD-L1 Tumor Cell Expression |
17.74; 9.79; 15.80; 10.89; 15.20; 10.37 | — |
| SECONDARY PFS by BICR by Tumor Mutational Burden |
8.94; 4.70; 5.62; 5.16; 6.37; 4.96 | — |
| SECONDARY ORR by BICR by Tumor Mutational Burden |
45.5; 29.3; 31.6; 27.0; 37.6; 27.9 | — |
| SECONDARY OS by Tumor Mutational Burden |
15.05; 10.76; 16.51; 12.55; 15.57; 12.06 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03215706) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.