Non Small Cell Lung CancerPhase 3CheckMate 816NCT02998528

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 study testing Nivolumab, Cisplatin and Vinorelbine in people with Non Small Cell Lung Cancer, run by Bristol-Myers Squibb at 138 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non Small Cell Lung Cancer
What is being tested?: Nivolumab, Cisplatin and Vinorelbine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 505 participants
Where: 138 sitesin 15 countries
Study dates: 4 Mar 2017to 6 Dec 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

138 sites in 15 countries.

Country

City, postcode or hospital

138 sites in 15 countries

United States57 sites

Local Institution - 0027
Albany, New York, 12208
Local Institution - 0035
Austin, Texas, 78745
Local Institution - 0151
Baltimore, Maryland, 21237
Local Institution - 0001
Baltimore, Maryland, 21287
Texas Oncology
Bedford, Texas, 76022
St Vincent Frontier Cancer Center
Billings, Montana, 59102
Local Institution - 0008
Boston, Massachusetts, 02215
Local Institution - 0135
Burlington, Vermont, 05405
Local Institution - 0013
Charleston, South Carolina, 29414
Local Institution - 0021
Charleston, South Carolina, 29425
Local Institution - 0015
Chicago, Illinois, 60611
Local Institution - 0002
Chicago, Illinois, 60637
Christ Hospital
Cincinnati, Ohio, 45219
MetroHealth Medical Center
Cleveland, Ohio, 44109
Local Institution - 0025
Denver, Colorado, 80218
Local Institution - 0012
Detroit, Michigan, 48202-2608
Local Institution - 0125
Fairfax, Virginia, 22031
Southcoast Center For Cancer
Fairhaven, Massachusetts, 02719
Local Institution - 0153
Fort Bliss, Texas, 79918
Local Institution - 0171
Fort Wayne, Indiana, 46804
Local Institution - 0198
Fredericksburg, Virginia, 22408
Local Institution - 0121
Glendale, Arizona, 85308
Local Institution - 0146
Greenville, South Carolina, 29607
Local Institution - 0009
Hackensack, New Jersey, 07601
Local Institution - 0090
Hattiesburg, Mississippi, 39401
Local Institution - 0140
High Point, North Carolina, 27262
Local Institution - 0173
Hollywood, Florida, 33021
Local Institution - 0106
Houston, Texas, 77090
Local Institution - 0032
Las Vegas, Nevada, 89128
Local Institution - 0170
Lexington, Kentucky, 40536
Local Institution - 0081
Los Angeles, California, 90017
Local Institution - 0186
Louisville, Kentucky, 40202
Southwest Cancer Center
Lubbock, Texas, 79415
Northwest Georgia Oncology Center, P.C.
Marietta, Georgia, 30060
Local Institution - 0136
Miami, Florida, 33136
Intermountain Medical Center
Murray, Utah, 84107
Local Institution - 0092
Nashville, Tennessee, 37203
Local Institution - 0005
Nashville, Tennessee, 37232
University Medical Center New Orleans
New Orleans, Louisiana, 70112
Local Institution - 0011
New York, New York, 10016
Local Institution - 0006
Newton, Massachusetts, 02459
Illinois Cancer Specialists
Niles, Illinois, 60714
Local Institution - 0054
Orlando, Florida, 32804
Orlando Health, Inc.
Orlando, Florida, 32806
Local Institution - 0010
Philadelphia, Pennsylvania, 19111
Local Institution - 0018
Pittsburgh, Pennsylvania, 15212
Local Institution - 0007
Plainville, Connecticut, 06062
Kaiser Permanente
Portland, Oregon, 97227
Local Institution - 0139
Portland, Oregon, 97239
Local Institution - 0003
Salt Lake City, Utah, 84112
Texas Cancer Center - Sherman
Sherman, Texas, 75090-0504
Southwest Regional Cancer Clinic
St. George, Utah, 84770
Local Institution - 0143
Tyler, Texas, 75701
Indian River Medical Center
Vero Beach, Florida, 32960
Local Institution - 0026
Waco, Texas, 76712
Valley Hospital Luckow Pavili
Westwood, New Jersey, 07675
Local Institution - 0149
Zanesville, Ohio, 43701

Other trials in United States

China19 sites

Local Institution - 0161
Beijing, Beijing Municipality, 100142
Local Institution
Beijing, Beijing Municipality, 100730
Local Institution - 0156
Beijing, Beijing Municipality, 100853
Local Institution
Changchun, Jilin, 130012
Local Institution - 0192
Changsha, Hunan, 410008
Local Institution - 0175
Changsha, Hunan, 410013
Local Institution - 0193
Changsha, Hunan, 410013
Local Institution - 0178
Chengdu, Sichuan, 610041
Local Institution - 0190
Guangzhou, Guangdong, 510095
Local Institution - 0189
Hangzhou, Zhejiang, 310003
Local Institution - 0183
Hangzhou, Zhejiang, 310016
Local Institution - 0182
Hangzhou, Zhejiang, 310022
Local Institution - 0179
Nanchang, Jiangxi, 330006
Local Institution - 0166
Nanchang, Jiangxi, 330200
Local Institution - 0160
Shanghai, Shanghai Municipality, 200032
Local Institution - 0165
Shanghai, 200030
Local Institution - 0163
Tianjin, Tianjin Municipality, 300060
Local Institution - 0159
Xi'an, Shan1xi, 710061
Local Institution - 0180
Xi'an, Shan3xi, 710038

Other trials in China

Japan16 sites

Local Institution - 0126
Bunkyo-ku, Tokyo, 1138431
Local Institution - 0110
Fukushima, Fukushima, 9601295
Local Institution - 0109
Hiroshima, Hiroshima, 7348551
Local Institution - 0118
Kashiwa-shi, Chiba, 2778577
Local Institution - 0111
Kitakyushu-shi, Fukuoka, 8078555
Local Institution - 0133
Kobe, Hyōgo, 6500047
Local Institution - 0131
Nagoya, Aichi-ken, 4640021
Local Institution - 0127
Osaka, Osaka, 5418567
Local Institution - 0108
Osaka, 589-8511
Local Institution - 0119
Sakai-shi, Osaka, 5918555
Local Institution - 0147
Sapporo, Hokkaido, 0030804
Local Institution - 0148
Sendai, Miyagi, 9800873
Local Institution - 0120
Shinjuku-ku, Tokyo, 1600023
Local Institution - 0132
Sunto-gun, Shizuoka, 4118777
Local Institution - 0124
Tokyo, 113-8603
Local Institution - 0123
Yokohama, Kanagawa, 2418515

Other trials in Japan

France8 sites

Local Institution - 0059
Marseille, 13915
Local Institution - 0060
Paris, 75018
Local Institution - 0112
Paris, 75248
Local Institution - 0064
Pierre Benite Cedax, 69495
Local Institution - 0061
Rennes, 35033
Local Institution - 0113
Strasbourg, 67100
Local Institution - 0058
Toulouse, 31059
Local Institution - 0062
Tours, 37044

Other trials in France

Brazil6 sites

Fundacao Pio Xii Hosp Cancer De Barretos
Barretos, São Paulo, 14784-400
Local Institution - 0077
Belo Horizonte, Minas Gerais, 30130-090
Local Institution - 0079
Brasília, Federal District, 70200-730
Local Institution - 0076
Ijuí, Rio Grande do Sul, 98700-000
Local Institution - 0073
Porto Alegre, Rio Grande do Sul, 90610-000
Local Institution - 0075
Rio de Janeiro, 22793-080

Other trials in Brazil

Canada5 sites

Local Institution - 0095
Gatineau, Quebec, J8P 7H2
Local Institution - 0138
Montreal, Quebec, H2X 0A9
Local Institution - 0017
Montreal, Quebec, H4A 3J1
Local Institution - 0016
Saskatoon, Saskatchewan, S7N 4H4
Local Institution - 0052
Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

Italy5 sites

Local Institution - 0068
Bari, 70124
Local Institution - 0080
Genova, 16132
Local Institution - 0070
Perugia, 06129
Local Institution - 0066
Ravenna, 48121
Local Institution - 0067
Roma, 00149

Other trials in Italy

Taiwan4 sites

Local Institution - 0102
New Taipei City, 235
Local Institution - 0107
Taichung, 407219
Local Institution - 0099
Taipei, 11031
Local Institution - 0100
Taipei, 112

Other trials in Taiwan

Romania3 sites

Local Institution - 0050
Craiova, 200347
Local Institution - 0051
Romania, 400015
Local Institution - 0069
Sector 2, 022328

Other trials in Romania

South Korea3 sites

Local Institution - 0097
Busan, 49267
Local Institution - 0098
Hwasun, 58128
Local Institution - 0105
Seoul, 08308

Other trials in South Korea

Spain3 sites

Local Institution - 0028
Barcelona, 08035
Local Institution - 0029
Madrid, 28041
Local Institution - 0031
Majadahonda - Madrid, 28222

Other trials in Spain

Turkey (Türkiye)3 sites

Local Institution - 0093
Adana, 01060
Local Institution - 0084
Ankara, 06100
Local Institution - 0115
Istanbul, 34098

Other trials in Turkey (Türkiye)

Argentina2 sites

Local Institution - 0022
Capital Federal, Buenos Aires, 1426
Local Institution - 0023
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181

Other trials in Argentina

Greece2 sites

Local Institution - 0019
Athens, 11527
Local Institution - 0122
Thessaloniki, 57001

Other trials in Greece

Hungary2 sites

Local Institution
Budapest, 1125
Local Institution
Székesfehérvár, 8000

Other trials in Hungary

About this study

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

This study has multiple primary endpoints.

Conditions: Non Small Cell Lung Cancer
Being tested: Nivolumab, Cisplatin, Vinorelbine, Gemcitabine, Docetaxel
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NivolumabBiological
Also called BMS-936558, Opdivo
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
VinorelbineDrug
Specified dose on specified days
GemcitabineDrug
Specified dose on specified days
DocetaxelDrug
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
PaclitaxelDrug
Specified dose on specified days
IpilimumabBiological
Also called BMS-734016, Yervoy
This arm is closed and no longer enrolling patients.

Study groups in NCT02998528
Study group	Role	What they receive
Platinum doublet chemotherapy	Active comparator	Specified dose on specified days Receives: Drug: Cisplatin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Docetaxel; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel
Nivolumab plus platinum doublet chemotherapy	Experimental	Specified dose on specified days Receives: Biological: Nivolumab; Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Carboplatin; Drug: Paclitaxel
Nivolumab plus Ipilimumab	Experimental	Specified dose on specified days Receives: Biological: Nivolumab; Biological: Ipilimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Event-Free Survival (EFS)
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).
Measured: From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
Pathologic Complete Response (pCR) Rate
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).
Measured: From randomization up to a median of 30 months after randomization.

Secondary outcomes (3)

Major Pathologic Response (MPR) Rate
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.
Measured: From randomization up to a median of 30 months after randomization.
Overall Survival (OS)
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.
Measured: From randomization to the date of death (Up to approximately 93 months)
Time to Death or Distant Metastases (TTDM)
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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 20176 Dec 2024

First posted20 Dec 2016 (estimated)
Study start4 Mar 2017
Primary completion8 Sep 2021
Study completion6 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 505 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02998528
Sponsor's protocol ID: CA209-816
Other IDs: 2016-003536-21, 2016
Acronym: CheckMate 816
Status last verified: Jan 2026
First submitted: 16 Dec 2016
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Expanded access: Available

Publications

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.
PubMed 40454642
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.
PubMed 39778121
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.
PubMed 37903504
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.
PubMed 37141544
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.
PubMed 36815433
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.
PubMed 35403841

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Non Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02998528
Acronym / sponsor ID: CheckMate 816 / CA209-816
Conditions: Non Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 505 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: Ono Pharmaceutical Co., Ltd.
Study start: 4 Mar 2017 (actual)
Primary completion: 8 Sep 2021 (actual)
Study completion: 6 Dec 2024 (actual)
First posted: 20 Dec 2016 (estimated)
Results: Posted 28 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study has multiple primary endpoints.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Platinum doublet chemotherapy	Active comparator	Drug: Cisplatin, Drug: Vinorelbine, Drug: Gemcitabine, Drug: Docetaxel, Drug: Pemetrexed, Drug: Carboplatin, Drug: PaclitaxelSpecified dose on specified days
Nivolumab plus platinum doublet chemotherapy	Experimental	Biological: Nivolumab, Drug: Cisplatin, Drug: Gemcitabine, Drug: Pemetrexed, Drug: Carboplatin, Drug: PaclitaxelSpecified dose on specified days
Nivolumab plus Ipilimumab	Experimental	Biological: Nivolumab, Biological: IpilimumabSpecified dose on specified days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NivolumabAlso: BMS-936558, OpdivoSpecified dose on specified days	Biological	Nivolumab plus Ipilimumab, Nivolumab plus platinum doublet chemotherapy
CisplatinSpecified dose on specified days	Drug	Nivolumab plus platinum doublet chemotherapy, Platinum doublet chemotherapy
VinorelbineSpecified dose on specified days	Drug	Platinum doublet chemotherapy
GemcitabineSpecified dose on specified days	Drug	Nivolumab plus platinum doublet chemotherapy, Platinum doublet chemotherapy
DocetaxelSpecified dose on specified days	Drug	Platinum doublet chemotherapy
PemetrexedSpecified dose on specified days	Drug	Nivolumab plus platinum doublet chemotherapy, Platinum doublet chemotherapy
CarboplatinSpecified dose on specified days	Drug	Nivolumab plus platinum doublet chemotherapy, Platinum doublet chemotherapy
PaclitaxelSpecified dose on specified days	Drug	Nivolumab plus platinum doublet chemotherapy, Platinum doublet chemotherapy
IpilimumabAlso: BMS-734016, YervoyThis arm is closed and no longer enrolling patients.	Biological	Nivolumab plus Ipilimumab

Primary outcome

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)
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).
Pathologic Complete Response (pCR) Rate
Time frame: From randomization up to a median of 30 months after randomization.
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).

3 secondary outcomes

Major Pathologic Response (MPR) Rate
Time frame: From randomization up to a median of 30 months after randomization.
Overall Survival (OS)
Time frame: From randomization to the date of death (Up to approximately 93 months)
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)

Results and safety

Results posted to the registry on 28 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg	113	112
Arm B: Platinum Doublet Chemo	213	207
Arm C: Nivo 360 mg + Platinum Doublet Chemo	179	176

Primary outcome: 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). Median (95% Confidence Interval). Unit: Months

Measure	Arm B: Platinum Doublet Chemo n = 179	Arm C: Nivo 360 mg + Platinum Doublet Chemo n = 179
Value	20.80 (14.03 to 26.71)	31.57 (30.16 to NA)

Arm B: Platinum Doublet Chemo vs Arm C: Nivo 360 mg + Platinum Doublet Chemo: Cox Proportional Hazard: 0.63 (97.38% CI 0.43 to 0.91), p = 0.0052, Log Rank

Population analysed: All concurrently randomized participants in Arm C and Arm B

Primary outcome: Pathologic Complete Response (pCR) Rate

Time frame: From randomization up to a median of 30 months after randomization.. Count of participants. Unit: Participants

Measure	Arm B: Platinum Doublet Chemo n = 179	Arm C: Nivo 360 mg + Platinum Doublet Chemo n = 179
Value	4	43

Arm B: Platinum Doublet Chemo vs Arm C: Nivo 360 mg + Platinum Doublet Chemo: % Difference: 21.6 (99% CI 13.0 to 30.3)
Arm B: Platinum Doublet Chemo vs Arm C: Nivo 360 mg + Platinum Doublet Chemo: Odds Ratio (OR): 13.94 (99% CI 3.49 to 55.75), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: All concurrently randomized participants in Arm C and Arm B

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality was assessed from randomization to study completion (up to approximately 93 months). SAEs and Other AEs were assessed from first dose to 100days after the last dose of neoadjuvant therapy or 90 days after surgery, whichever is longer, and 30 days after the last dose of adjuvant therapy (up to approximately 5.5 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg	30 of 111 (27%)	102 of 111 (91.9%)	46 of 112
Arm B: Platinum Doublet Chemo	58 of 208 (27.9%)	202 of 208 (97.1%)	105 of 214
Arm C: Nivo 360 mg + Platinum Doublet Chemo	53 of 176 (30.1%)	160 of 176 (90.9%)	66 of 179

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40454642Forde 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.
Derived from this study: PubMed 39778121Awad 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.
Derived from this study: PubMed 37903504Deutsch 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.
Derived from this study: PubMed 37141544Akinboro 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.
Derived from this study: PubMed 36815433Forde 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.
Derived from this study: PubMed 35403841Forde 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.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

Related trials for Non Small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

138 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Cisplatin and Vinorelbine in people with Non Small Cell Lung Cancer, run by Bristol-Myers Squibb at 138 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, China, Japan, France, Brazil and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02998528, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.