Phase 3
Completed N=505
A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung Cancer
Source: ClinicalTrials.gov NCT02998528 ↗
Enrolled (actual)
505
Serious AEs
28.5%
Results posted
Sep 2022
Primary outcomePrimary: Event-Free Survival (EFS) — 20.80; 31.57 Months — p=0.0052
◆ Published Evidence
Highly cited
162citations · ~81 / year
Association between pathologic response and survival after neoadjuvant therapy in lung cancer.
Summary
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC.
This study has multiple primary endpoints.
Linked Publications (5)
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Association between pathologic response and survival after neoadjuvant therapy in lung cancer.
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Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer.
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US Food and Drug Administration Approval Summary: Nivolumab Plus Platinum-Doublet Chemotherapy for the Neoadjuvant Treatment of Patients With Resectable Non-Small-Cell Lung Cancer.
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Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer.
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Plain language summary of the CheckMate 816 study results: nivolumab plus chemotherapy given before surgery for non-small-cell lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Event-Free Survival (EFS) |
21.06; 59.60 | — |
| PRIMARY Pathologic Complete Response (pCR) Rate |
4; 43 | <0.0001 sig |
| SECONDARY Major Pathologic Response (MPR) Rate |
16; 66 | — |
| SECONDARY Overall Survival (OS) |
73.72; NA | — |
| SECONDARY Time to Death or Distant Metastases (TTDM) |
36.76; 64.66 | — |
Eligibility Criteria
Inclusion Criteria
- Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue
- Lung function capacity capable of tolerating the proposed lung surgery
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- Available tissue of primary lung tumor
Exclusion Criteria
- Presence of locally advanced, inoperable or metastatic disease
- Participants with active, known or suspected autoimmune disease
- Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
Other protocol defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02998528) 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.