TriangleNCT02998528 · CITED IN SOURCE DOCUMENTS
A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2026-01-06
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Specified dose on specified days
- intervention Names
- Drug: Cisplatin
- Drug: Vinorelbine
- Drug: Gemcitabine
- Drug: Docetaxel
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Paclitaxel
- label
- Platinum doublet chemotherapy
- type
- ACTIVE_COMPARATOR
- description
- Specified dose on specified days
- intervention Names
- Biological: Nivolumab
- Drug: Cisplatin
- Drug: Gemcitabine
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Paclitaxel
- label
- Nivolumab plus platinum doublet chemotherapy
- type
- EXPERIMENTAL
- description
- Specified dose on specified days
- intervention Names
- Biological: Nivolumab
- Biological: Ipilimumab
- label
- Nivolumab plus Ipilimumab
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Nivolumab plus Ipilimumab
- Nivolumab plus platinum doublet chemotherapy
- description
- Specified dose on specified days
- name
- Nivolumab
- other Names
- BMS-936558
- Opdivo
- type
- BIOLOGICAL
- arm Group Labels
- Nivolumab plus platinum doublet chemotherapy
- Platinum doublet chemotherapy
- description
- Specified dose on specified days
- name
- Cisplatin
- type
- DRUG
- arm Group Labels
- Platinum doublet chemotherapy
- description
- Specified dose on specified days
- name
- Vinorelbine
- type
- DRUG
- arm Group Labels
- Nivolumab plus platinum doublet chemotherapy
- Platinum doublet chemotherapy
- description
- Specified dose on specified days
- name
- Gemcitabine
- type
- DRUG
- arm Group Labels
- Platinum doublet chemotherapy
- description
- Specified dose on specified days
- name
- Docetaxel
- type
- DRUG
- arm Group Labels
- Nivolumab plus platinum doublet chemotherapy
- Platinum doublet chemotherapy
- description
- Specified dose on specified days
- name
- Pemetrexed
- type
- DRUG
- arm Group Labels
- Nivolumab plus platinum doublet chemotherapy
- Platinum doublet chemotherapy
- description
- Specified dose on specified days
- name
- Carboplatin
- type
- DRUG
- arm Group Labels
- Nivolumab plus platinum doublet chemotherapy
- Platinum doublet chemotherapy
- description
- Specified dose on specified days
- name
- Paclitaxel
- type
- DRUG
- arm Group Labels
- Nivolumab plus Ipilimumab
- description
- This arm is closed and no longer enrolling patients.
- name
- Ipilimumab
- other Names
- BMS-734016
- Yervoy
- type
- BIOLOGICAL
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 505
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
- measure
- Event-Free Survival (EFS)
- time Frame
- From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
- description
- Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).
- measure
- Pathologic Complete Response (pCR) Rate
- time Frame
- From randomization up to a median of 30 months after randomization.
- secondary Outcomes
- description
- Major pathologic response (MPR) rate is defined as number of randomized participants with \</= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
- measure
- Major Pathologic Response (MPR) Rate
- time Frame
- From randomization up to a median of 30 months after randomization.
- description
- Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.
- measure
- Overall Survival (OS)
- time Frame
- From randomization to the date of death (Up to approximately 93 months)
- description
- TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.
- measure
- Time to Death or Distant Metastases (TTDM)
- time Frame
- From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to approximately 84 months)
Full study description
- brief 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.
Source references
- references
- citation
- Forde PM, Spicer JD, Provencio M, Mitsudomi T, Awad MM, Wang C, Lu S, Felip E, Swanson SJ, Brahmer JR, Kerr K, Taube JM, Ciuleanu TE, Tanaka F, Saylors GB, Chen KN, Ito H, Liberman M, Martin C, Broderick S, Wang L, Cai J, Duong Q, Meadows-Shropshire S, Fiore J, Bhatia S, Girard N; CheckMate 816 Investigators. Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer. N Engl J Med. 2025 Aug 21;393(8):741-752. doi: 10.1056/NEJMoa2502931. Epub 2025 Jun 2.
- pmid
- 40454642
- type
- DERIVED
- citation
- Awad MM, Forde PM, Girard N, Spicer J, Wang C, Lu S, Mitsudomi T, Felip E, Broderick SR, Swanson SJ, Brahmer J, Kerr K, Saylors GB, Chen KN, Gharpure V, Neely J, Balli D, Hu N, Provencio Pulla M. Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer. J Clin Oncol. 2025 Apr 20;43(12):1453-1462. doi: 10.1200/JCO-24-02239. Epub 2025 Jan 8.
- pmid
- 39778121
- type
- DERIVED
- citation
- Deutsch JS, Cimino-Mathews A, Thompson E, Provencio M, Forde PM, Spicer J, Girard N, Wang D, Anders RA, Gabrielson E, Illei P, Jedrych J, Danilova L, Sunshine J, Kerr KM, Tran M, Bushong J, Cai J, Devas V, Neely J, Balli D, Cottrell TR, Baras AS, Taube JM. Association between pathologic response and survival after neoadjuvant therapy in lung cancer. Nat Med. 2024 Jan;30(1):218-228. doi: 10.1038/s41591-023-02660-6. Epub 2023 Oct 30.
- pmid
- 37903504
- type
- DERIVED
- citation
- Akinboro O, Drezner N, Amatya A, Runyan J, Fourie-Zirkelbach J, Zhao M, Bi Y, Korsah K, Mixter B, Tang S, Larkins E, Pazdur R, Beaver JA, Singh H. 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. J Clin Oncol. 2023 Jun 10;41(17):3249-3259. doi: 10.1200/JCO.22.02509. Epub 2023 May 4.
- pmid
- 37141544
- type
- DERIVED
- citation
- Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N. Plain language summary of the CheckMate 816 study results: nivolumab plus chemotherapy given before surgery for non-small-cell lung cancer. Future Oncol. 2023 Mar;19(8):549-557. doi: 10.2217/fon-2023-0007. Epub 2023 Feb 23.
- pmid
- 36815433
- type
- DERIVED
- citation
- Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. doi: 10.1056/NEJMoa2202170. Epub 2022 Apr 11.
- pmid
- 35403841
- type
- DERIVED
- see Also Links
- label
- BMS Clinical Trial Information
- label
- BMS Clinical Trial Patient Recruiting
Source notices and limitations
Discovery and provenance
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- e of OPDIVO QVANTIG for this indication is supported by evidence from adequate and well-controlled studies conducted with intravenous nivolumab (CHECKMATE-816, NCT02998528), and additional pharmacokinetic and safety data that demonstrated comparable pharmacokinetics and safety profiles between OPDIVO QVANTIG and intravenous nivol
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- ription of the efficacy results of the adequate and well-controlled study of intravenous nivolumab in this lung cancer population. CHECKMATE-816 CHECKMATE-816 (NCT02998528) was a randomized, open label trial in patients with resectable NSCLC. The trial included patients with resectable, histologically confirmed Stage IB (≥4 cm),
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Preserved source evidence · Not medical advice