A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816)
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ClinicalTrials.gov Identifier: NCT02998528 |
Recruitment Status :
Active, not recruiting
First Posted : December 20, 2016
Last Update Posted : March 15, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Biological: Nivolumab Drug: Cisplatin Drug: Vinorelbine Drug: Gemcitabine Drug: Docetaxel Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel Biological: Ipilimumab | Phase 3 |
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 505 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC |
Actual Study Start Date : | March 4, 2017 |
Actual Primary Completion Date : | September 8, 2021 |
Estimated Study Completion Date : | November 8, 2028 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Platinum doublet chemotherapy
Specified dose on specified days
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Drug: Cisplatin
Specified dose on specified days Drug: Vinorelbine Specified dose on specified days Drug: Gemcitabine Specified dose on specified days Drug: Docetaxel Specified dose on specified days Drug: Pemetrexed Specified dose on specified days Drug: Carboplatin Specified dose on specified days Drug: Paclitaxel Specified dose on specified days |
Experimental: Nivolumab plus platinum doublet chemotherapy
Specified dose on specified days
|
Biological: Nivolumab
Specified dose on specified days
Other Names:
Drug: Cisplatin Specified dose on specified days Drug: Gemcitabine Specified dose on specified days Drug: Pemetrexed Specified dose on specified days Drug: Carboplatin Specified dose on specified days Drug: Paclitaxel Specified dose on specified days |
Experimental: Nivolumab plus Ipilimumab
Specified dose on specified days
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Biological: Nivolumab
Specified dose on specified days
Other Names:
Biological: Ipilimumab This arm is closed and no longer enrolling patients.
Other Names:
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- Event-Free Survival (EFS) [ Time Frame: Up to 69 months ]
- Pathological Complete Response (pCR) [ Time Frame: At the time of surgery ]
- Overall survival (OS) [ Time Frame: Up to approximately 193 months ]
- Major pathological response (MPR) [ Time Frame: At time of surgery ]
- Time to Death or Distant Metastases (TTDM) [ Time Frame: Up to 69 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998528

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02998528 |
Other Study ID Numbers: |
CA209-816 2016-003536-21 ( EudraCT Number ) |
First Posted: | December 20, 2016 Key Record Dates |
Last Update Posted: | March 15, 2022 |
Last Verified: | February 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Gemcitabine Paclitaxel Vinorelbine Docetaxel Carboplatin |
Nivolumab Pemetrexed Ipilimumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents |