Carcinoma, Non-Small-Cell LungPhase 3NCT04025879
A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer
A Phase 3 study testing Nivolumab, Carboplatin and Cisplatin in people with Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 108 sites in 22 countries.
Trial summary
The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Nivolumab, Carboplatin and Cisplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 461 participants
- Where
- 108 sitesin 22 countries
- Study dates
- 5 Nov 2019to 31 Jul 2027
- Phase
- Phase 3
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
- Participants with suspected or histologically confirmed Stage IIA (> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
- No brain metastasis
- Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
- Ability to provide surgical or biopsy tumor tissue for biomarkers
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Who cannot join
- Participants with an active, known or suspected autoimmune disease
- Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
- Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
- Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
108 sites in 22 countries.
108 sites in 22 countries
United States15 sites
Local Institution - 0040
Atlanta, Georgia, 30342
Local Institution - 0120
Augusta, Georgia, 30912
Rcca Md Llc
Bethesda, Maryland, 20817
Local Institution - 0076
Boston, Massachusetts, 02215
Local Institution - 0145
Chicago, Illinois, 60611
Local Institution - 0078
Chicago, Illinois, 60612
Local Institution - 0055
Cincinnati, Ohio, 45220
Local Institution - 0102
Cleveland, Ohio, 44106
Local Institution - 0103
Fredericksburg, Virginia, 22408
Local Institution - 0054
Houston, Texas, 77030
Local Institution - 0100
Lebanon, New Hampshire, 03756
Local Institution - 0074
Newton, Massachusetts, 02459
Local Institution - 0121
Orland Park, Illinois, 60462
Local Institution - 0104
Tampa, Florida, 33612
Local Institution - 0086
Traverse City, Michigan, 49684
Japan15 sites
Local Institution - 0142
Bunkyo-ku, Tokyo, 1138431
Local Institution - 0133
Bunkyo-ku, Tokyo, 1138603
Local Institution - 0143
Chuo-ku, Tokyo, 1040045
Local Institution - 0134
Chuo-ku, Tokyo, 5418567
Local Institution - 0132
Fukushima, 960-1295
Local Institution - 0128
Hiroshima, Hiroshima, 734-8551
Local Institution - 0144
Kanazawa, Ishikawa-ken, 9208641
Local Institution - 0124
Kashiwa-shi, Chiba, 2778577
Local Institution - 0130
Kitaadachigun, Saitama, 3620806
Local Institution - 0129
Kitakyushu-shi, Fukuoka, 8078556
Local Institution - 0127
Kobe, Hyōgo, 6500047
Local Institution - 0135
Nagoya, Aichi-ken, 4640021
Local Institution - 0126
Sakai-shi, Osaka, 5918555
Local Institution - 0131
Sendai, Miyagi, 9800873
Local Institution - 0125
Yokohama, Kanagawa, 241-8515
China14 sites
Local Institution - 0115
Beijing, Beijing Municipality, 100021
Local Institution - 0096
Beijing, BEI, 100142
Local Institution - 0092
Changsha, Hunan, 410000
Local Institution - 0093
Changsha, Hunan, 410000
Local Institution - 0091
Changsha, Hunan, 410008
Local Institution - 0088
Chengdu, Sichuan, 610041
Local Institution - 0137
Fuzhou, Fujian, 350001
Local Institution - 0136
Fuzhou, Fujian, 350014
Local Institution - 0099
Hangzhou, Zhejiang, 310016
Local Institution - 0151
Hubei Sheng, Hubei, 430079
Local Institution - 0098
Shanghai, Shanghai Municipality, 200010
Local Institution - 0165
Shanghai, Shanghai Municipality, 200030
Local Institution - 0113
Shanghai, Shanghai Municipality, 200433
Local Institution - 0095
Shanghai, 200032
Germany12 sites
Local Institution - 0085
Berlin, 13353
Local Institution - 0110
Cologne, North Rhine-Westphalia, 51109
Local Institution - 0065
Frankfurt, 60488
Local Institution - 0072
Georgsmarienhütte, 49124
Local Institution - 0071
Hamm, 59063
Local Institution - 0108
Heidelberg, 69126
Local Institution - 0109
Immenstadt im Allgäu, Bavaria, 87509
Local Institution - 0064
Löwenstein, 74245
Local Institution - 0063
Lübeck, 23538
Local Institution - 0147
Ludwigsburg, 71640
Local Institution - 0070
Moers, 47441
Local Institution - 0066
München, 81675
France7 sites
Local Institution - 0073
Besançon, 25030
Local Institution - 0037
La Tronche, 38700
Local Institution - 0050
Montpellier, 34295
Local Institution - 0038
Paris, 75018
Local Institution - 0051
Paris, 75970
Local Institution - 0083
Rennes, 35033
Local Institution - 0146
Rouen, 76000
Brazil5 sites
Local Institution - 0035
Belo Horizonte, Minas Gerais, 30130-090
Local Institution - 0029
Ijuí, Rio Grande do Sul, 98700-000
Local Institution - 0106
São Paulo, São Paulo, 01321-001
Local Institution - 0036
São Paulo, São Paulo, 01509-010
Local Institution - 0034
São Paulo, São Paulo, 05652-900
Argentina4 sites
Local Institution - 0031
ABB, Buenos Aires F.D., C1199ABB
Local Institution - 0043
Buenos Aires, Buenos Aires, CP1280AEB
Local Institution - 0030
CABA, 1426
Local Institution - 0032
Ciudad Autonoma Beunos Aires, Buenos Aires, 1431
Australia4 sites
Local Institution - 0033
Heidelberg, Victoria, 3084
Local Institution - 0122
Melbourne, Victoria, 3065
Local Institution - 0023
North Ballarat, Victoria, 33500
Local Institution - 0020
Sydney, New South Wales, 2050
Russia4 sites
Local Institution
Moscow, 115478
Local Institution
Saint Petersburg, 194291
Local Institution
Saint Petersburg, 197758
Local Institution
Saint Petersburg, 198255
Taiwan4 sites
Local Institution - 0149
Kaohsiung City, 807
Local Institution - 0119
Kaohsiung City, 833
Local Institution - 0116
New Taipei City, 235
Local Institution - 0112
Taipei, 100225
Belgium3 sites
Local Institution - 0002
Edegem, 2650
Local Institution - 0005
Liège, 4000
Local Institution - 0001
Roeselare, 8800
Italy3 sites
Local Institution - 0024
Forlì, 47014
Local Institution - 0026
Milan, 20122
Local Institution - 0025
Parma, 43126
Mexico3 sites
Local Institution - 0028
Chihuahua City, Chihuahua, 31000
Local Institution - 0077
Guadalajara, Jalisco, 44280
Local Institution - 0027
Monterrey, Nuevo León, 64460
Romania3 sites
Local Institution - 0011
Bucharest, 022328
Local Institution - 0013
Cluj-Napoca, Cluj, 400015
Local Institution - 0012
Floreşti, 407280
Spain3 sites
Local Institution - 0046
Madrid, 28006
Local Institution - 0044
Majadahonda - Madrid, 28222
Local Institution - 0045
Valencia, 46026
Czechia2 sites
Local Institution - 0041
Prague, 128 08
Local Institution - 0042
Prague, 140 59
Netherlands2 sites
Local Institution - 0004
Groningen, 9700RB
Local Institution - 0003
Rotterdam, 3015 GD
Poland1 site
Local Institution - 0049
Krakow, Lesser Poland Voivodeship, 31-202
About this study
Official title: A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Resection and Adjuvant Treatment With Nivolumab or Placebo for Participants With Resectable Stage II-IIIB Non-small Cell Lung Cancer
The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Nivolumab, Carboplatin, Cisplatin, Paclitaxel, Pemetrexed
- 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 Opdivo, BMS936558
Specified dose on specified days
CarboplatinDrug
Specified dose on specified days
CisplatinDrug
Specified dose on specified days
PaclitaxelDrug
Specified dose on specified days
PemetrexedDrug
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
DocetaxelDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo | Experimental | Not described Receives: Biological: Nivolumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Docetaxel |
| Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. | Placebo comparator | Not described Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Placebo; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS) by BICR
The length of time from randomization to any of the following events: progression of disease or worsening of disease precluding surgery, if surgery is attempted but gross resection is abandoned due to unresectable tumor or worsening of disease, progression or recurrence of disease after surgery, progression or recurrence of disease without surgery, or death due to any cause. Progression/recurrence will be assessed by BICR per RECIST 1.1. Participants who do not undergo surgery for reason other than progression will be considered to have an event at RECIST 1.1 progression or death
Measured: From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)
Secondary outcomes (6)
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a subject was known to be alive.
Measured: From randomization and the date of death due to any cause.
Pathologic Complete Response (pCR) Rate
Pathologic complete response (pCR) rate is defined as the percentage of randomized participants with absence of residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
Measured: From randomization up to approximately 44 months
Major Pathological Response (MPR) Rate
Major pathological response (MPR) rate is defined as the percentage of randomized participants with ≤10% residual viable tumor in lung and lymph nodes as evaluated by blinded independent pathology review (BIPR).
Measured: From randomization up to approximately 44 months
The Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Measured: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
The Number of Participants With Serious Adverse Events (SAEs)
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.
Measured: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
The Number of Participants With Select Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Select AEs include endocrinopathies, diarrhea/colitis, hepatitis, pneumonitis, interstitial nephritis, and rash. Multiple event terms that may describe each of these were grouped into endocrine, GI, hepatic, pulmonary, renal, and skin select AE categories, respectively. Hypersensitivity/infusion reactions were analyzed along with the select AE categories.
Measured: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start5 Nov 2019
- Primary completion26 Jul 2023
- Study completion31 Jul 2027 (estimated)
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 Carcinoma, Non-Small-Cell LungStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 461 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025879
- Sponsor's protocol ID
- CA209-77T
- Other IDs
- 2019-000262-38, 2019
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2019
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Publications
Cascone T, Awad MM, Spicer JD, He J, Lu S, Tanaka F, Cornelissen R, Petruzelka LB, Gao Y, Pujol JL, Ito H, de Oliveira Muniz Koch L, Ciuleanu TE, Wu L, Bohnet S, Watanabe Y, Taube JM, Deutsch JS, Erdmann CC, Meadows-Shropshire S, Neely J, Ip V, Hung YH, Sathyanarayana P, Bhatia S, Chu K, Blum SI, Lucherini S, Eddy N, Yadav A, Provencio M. Biomarkers of nivolumab benefit in resectable non-small cell lung cancer. Nature. 2026 Aug 12. doi: 10.1038/s41586-026-10925-6. Online ahead of print.
PubMed 42587156Provencio M, Awad MM, Spicer JD, Janssens A, Moiseyenko F, Gao Y, Watanabe Y, Alexandru A, Guisier F, Frost N, Franke F, Hiltermann TJN, He J, Tanaka F, Lu S, Coronado Erdmann C, Sathyanarayana P, Tran P, Devas V, Cascone T. Clinical outcomes with perioperative nivolumab by nodal status in patients with stage III resectable NSCLC: phase 3 CheckMate 77T exploratory analysis. Nat Cancer. 2026 Jan;7(1):169-181. doi: 10.1038/s43018-025-01104-z. Epub 2026 Jan 8.
PubMed 41507539Tanaka F, Watanabe Y, Sugawara S, Okami J, Muto S, Okada M, Horio Y, Tsuboi M, Sato Y, Takamochi K, Horinouchi H, Tambo Y, Seike M, Okishio K, Coronado Erdmann C, Sathyanarayana P, Meadows-Shropshire S, Ito H. Perioperative Nivolumab in Resectable Non-Small Cell Lung Cancer: A Subanalysis of Japanese Patients From CheckMate 77T. Cancer Sci. 2026 Mar;117(3):759-768. doi: 10.1111/cas.70300. Epub 2025 Dec 23.
PubMed 41431434Cascone T, Awad MM, Spicer JD, He J, Lu S, Sepesi B, Tanaka F, Taube JM, Cornelissen R, Havel L, Karaseva N, Kuzdzal J, Petruzelka LB, Wu L, Pujol JL, Ito H, Ciuleanu TE, de Oliveira Muniz Koch L, Janssens A, Alexandru A, Bohnet S, Moiseyenko FV, Gao Y, Watanabe Y, Coronado Erdmann C, Sathyanarayana P, Meadows-Shropshire S, Blum SI, Provencio Pulla M; CheckMate 77T Investigators. Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med. 2024 May 16;390(19):1756-1769. doi: 10.1056/NEJMoa2311926.
PubMed 38749033Leal TA, Ramalingam SS. Neoadjuvant therapy gains FDA approval in non-small cell lung cancer. Cell Rep Med. 2022 Jul 19;3(7):100691. doi: 10.1016/j.xcrm.2022.100691.
PubMed 35858590Hong WX, Sagiv-Barfi I, Czerwinski DK, Sallets A, Levy R. Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-OX40 Antibody Eradicates Metastatic Cancer. Cancer Res. 2022 Apr 1;82(7):1396-1408. doi: 10.1158/0008-5472.CAN-21-1382.
PubMed 35135810