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

October 7, 2025 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, CP1280AEB
        • Local Institution - 0043
      • CABA, Argentina, 1426
        • Local Institution - 0030
    • Buenos Aires
      • Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina, 1431
        • Local Institution - 0032
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Local Institution - 0031
  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Local Institution - 0020
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0033
      • Melbourne, Victoria, Australia, 3065
        • Local Institution - 0122
      • North Ballarat, Victoria, Australia, 33500
        • Local Institution - 0023
  • Belgium
      • Edegem, Belgium, 2650
        • Local Institution - 0002
      • Liège, Belgium, 4000
        • Local Institution - 0005
      • Roeselare, Belgium, 8800
        • Local Institution - 0001
  • Brazil
      • São Paulo, Brazil, 01321-001
        • Local Institution - 0106
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-090
        • Local Institution - 0035
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Local Institution - 0029
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01509-010
        • Local Institution - 0036
      • São Paulo, São Paulo, Brazil, 05652-900
        • Local Institution - 0034
  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • Local Institution - 0062
  • China
      • Shanghai, China, 200032
        • Local Institution - 0095
    • BEI
      • Beijing, BEI, China, 100142
        • Local Institution - 0096
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Local Institution - 0115
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Local Institution - 0137
      • Fuzhou, Fujian, China, 350014
        • Local Institution - 0136
    • Hubei
      • Hubei Sheng, Hubei, China, 430079
        • Local Institution - 0151
    • Hunan
      • Changsha, Hunan, China, 410000
        • Local Institution - 0092
      • Changsha, Hunan, China, 410000
        • Local Institution - 0093
      • Changsha, Hunan, China, 410008
        • Local Institution - 0091
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200010
        • Local Institution - 0098
      • Shanghai, Shanghai Municipality, China, 200030
        • Local Institution - 0165
      • Shanghai, Shanghai Municipality, China, 200433
        • Local Institution - 0113
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0088
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Local Institution - 0099
  • Czechia
      • Prague, Czechia, 128 08
        • Local Institution - 0041
      • Prague, Czechia, 140 59
        • Local Institution - 0042
  • France
      • Besançon, France, 25030
        • Local Institution - 0073
      • La Tronche, France, 38700
        • Local Institution - 0037
      • Montpellier, France, 34295
        • Local Institution - 0050
      • Paris, France, 75018
        • Local Institution - 0038
      • Paris, France, 75970
        • Local Institution - 0051
      • Rennes, France, 35033
        • Local Institution - 0083
      • Rouen, France, 76000
        • Local Institution - 0146
  • Germany
      • Berlin, Germany, 13353
        • Local Institution - 0085
      • Frankfurt, Germany, 60488
        • Local Institution - 0065
      • Georgsmarienhütte, Germany, 49124
        • Local Institution - 0072
      • Hamm, Germany, 59063
        • Local Institution - 0071
      • Heidelberg, Germany, 69126
        • Local Institution - 0108
      • Ludwigsburg, Germany, 71640
        • Local Institution - 0147
      • Löwenstein, Germany, 74245
        • Local Institution - 0064
      • Lübeck, Germany, 23538
        • Local Institution - 0063
      • Moers, Germany, 47441
        • Local Institution - 0070
      • München, Germany, 81675
        • Local Institution - 0066
    • Bavaria
      • Immenstadt im Allgäu, Bavaria, Germany, 87509
        • Local Institution - 0109
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 51109
        • Local Institution - 0110
  • Ireland
      • Dublin, Ireland, D24 DH74
        • Local Institution - 0016
  • Italy
      • Forlì, Italy, 47014
        • Local Institution - 0024
      • Milan, Italy, 20122
        • Local Institution - 0026
      • Parma, Italy, 43126
        • Local Institution - 0025
  • Japan
      • Fukushima, Japan, 960-1295
        • Local Institution - 0132
      • Hiroshima, Japan, 734-8551
        • Local Institution - 0128
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 4640021
        • Local Institution - 0135
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0124
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 8078556
        • Local Institution - 0129
    • Hyōgo
      • Kobe, Hyōgo, Japan, 6500047
        • Local Institution - 0127
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 9208641
        • Local Institution - 0144
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Local Institution - 0125
    • Miyagi
      • Sendai, Miyagi, Japan, 9800873
        • Local Institution - 0131
    • Osaka
      • Sakai-shi, Osaka, Japan, 5918555
        • Local Institution - 0126
    • Saitama
      • Kitaadachigun, Saitama, Japan, 3620806
        • Local Institution - 0130
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138431
        • Local Institution - 0142
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Local Institution - 0133
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0143
      • Chuo-ku, Tokyo, Japan, 5418567
        • Local Institution - 0134
  • Mexico
      • Chihuahua City, Mexico, 31000
        • Local Institution - 0028
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Local Institution - 0077
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Local Institution - 0027
  • Netherlands
      • Groningen, Netherlands, 9700RB
        • Local Institution - 0004
      • Rotterdam, Netherlands, 3015 GD
        • Local Institution - 0003
  • Poland
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-202
        • Local Institution - 0049
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00917
        • Local Institution - 0117
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0011
      • Floreşti, Romania, 407280
        • Local Institution - 0012
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Local Institution - 0013
  • Russia
      • Moscow, Russia, 115478
        • Local Institution
      • Saint Petersburg, Russia, 194291
        • Local Institution
      • Saint Petersburg, Russia, 197758
        • Local Institution
      • Saint Petersburg, Russia, 198255
        • Local Institution
  • Spain
      • Madrid, Spain, 28006
        • Local Institution - 0046
      • Majadahonda - Madrid, Spain, 28222
        • Local Institution - 0044
      • Valencia, Spain, 46026
        • Local Institution - 0045
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Local Institution - 0149
      • Kaohsiung City, Taiwan, 833
        • Local Institution - 0119
      • New Taipei City, Taiwan, 235
        • Local Institution - 0116
      • Taipei, Taiwan, 100225
        • Local Institution - 0112
  • United Kingdom
      • Taunton, United Kingdom, TA1 5DA
        • Local Institution - 0007
  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Local Institution - 0104
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 0040
      • Augusta, Georgia, United States, 30912
        • Local Institution - 0120
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Local Institution - 0145
      • Chicago, Illinois, United States, 60612
        • Local Institution - 0078
      • Orland Park, Illinois, United States, 60462
        • Local Institution - 0121
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Rcca Md Llc
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0076
      • Newton, Massachusetts, United States, 02459
        • Local Institution - 0074
    • Michigan
      • Traverse City, Michigan, United States, 49684
        • Local Institution - 0086
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Local Institution - 0100
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Local Institution - 0055
      • Cleveland, Ohio, United States, 44106
        • Local Institution - 0102
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 0054
    • Virginia
      • Fredericksburg, Virginia, United States, 22408
        • Local Institution - 0103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo, BMS936558
Drug: Carboplatin
Specified dose on specified days
Drug: Cisplatin
Specified dose on specified days
Drug: Paclitaxel
Specified dose on specified days
Drug: Pemetrexed
Specified dose on specified days
Drug: Docetaxel
Specified dose on specified days
Placebo Comparator: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.
Drug: Placebo
Specified dose on specified days
Drug: Carboplatin
Specified dose on specified days
Drug: Cisplatin
Specified dose on specified days
Drug: Paclitaxel
Specified dose on specified days
Drug: Pemetrexed
Specified dose on specified days
Drug: Docetaxel
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS) by BICR
Time Frame: From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)
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
From randomization to disease progression, worsening, recurrence, or death due to any cause (up to approximately 44 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization and the date of death due to any cause.
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.
From randomization and the date of death due to any cause.
Pathologic Complete Response (pCR) Rate
Time Frame: From randomization up to approximately 44 months
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).
From randomization up to approximately 44 months
Major Pathological Response (MPR) Rate
Time Frame: From randomization up to approximately 44 months
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).
From randomization up to approximately 44 months
The Number of Participants With Adverse Events (AEs)
Time Frame: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
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.
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)
Time Frame: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)
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.
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)
Time Frame: From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)

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.
From first treatment to 30 days after last treatment of study therapy including definitive surgery and radiotherapy (up to approximately 28 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2019

Primary Completion (Actual)

July 26, 2023

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Estimated)

October 16, 2025

Last Update Submitted That Met QC Criteria

October 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-77T
  • 2019-000262-38 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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