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

April 5, 2024 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)

482

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
    • Ciudad Autónoma De Buenos Aires
      • ABB, Ciudad Autónoma De Buenos Aires, 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
      • Liege, 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
      • Ijui, RIO Grande DO SUL, Brazil, 98700-000
        • Local Institution - 0029
    • SAO Paulo
      • São Paulo, SAO Paulo, Brazil, 05652-900
        • Local Institution - 0034
    • São Paulo
      • Sao Paulo, São Paulo, Brazil, 01509-010
        • Local Institution - 0036
  • 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
      • Beijing, Beijing, 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
      • Shanghai, Shanghai, China, 200010
        • Local Institution - 0098
      • Shanghai, Shanghai, China, 200030
        • Local Institution - 0165
      • Shanghai, Shanghai, China, 200433
        • Local Institution - 0113
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0088
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Local Institution - 0099
  • Czechia
      • Praha 2, Czechia, 128 08
        • Local Institution - 0041
      • Praha 4, Czechia, 140 59
        • Local Institution - 0042
  • France
      • Besancon, France, 25030
        • Local Institution - 0073
      • La Tronche, France, 38700
        • Local Institution - 0037
      • Montpellier, France, 34295
        • Local Institution - 0050
      • Paris Cedex 18, France, 75018
        • Local Institution - 0038
      • Paris Cedex 20, France, 75970
        • Local Institution - 0051
      • Rennes Cedex 9, France, 35033
        • Local Institution - 0083
      • Rouen, France, 76000
        • Local Institution - 0146
  • Germany
      • Berlin, Germany, 13353
        • Local Institution - 0085
      • Frankfurt, Germany, 60488
        • Local Institution - 0065
      • Georgsmarienhuette, Germany, 49124
        • Local Institution - 0072
      • Hamm, Germany, 59063
        • Local Institution - 0071
      • Heidelberg, Germany, 69126
        • Local Institution - 0108
      • Immenstadt, Germany, 87509
        • Local Institution - 0109
      • Loewenstein, Germany, 74245
        • Local Institution - 0064
      • Ludwigsburg, Germany, 71640
        • Local Institution - 0147
      • Luebeck, Germany, 23538
        • Local Institution - 0063
      • Moers, Germany, 47441
        • Local Institution - 0070
      • Muenchen, Germany, 81675
        • Local Institution - 0066
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 51109
        • Local Institution - 0110
  • Ireland
      • Dublin, Ireland, D24 DH74
        • Local Institution - 0016
  • Italy
      • Forlì, Italy, 47014
        • Local Institution - 0024
      • Milano, Italy, 20122
        • Local Institution - 0026
      • Parma, Italy, 43126
        • Azienda Ospedaliera Di Parma
  • Japan
      • Fukushima-shi, Japan, 960-1295
        • Local Institution - 0132
      • Hiroshima, Japan, 734-8551
        • Local Institution - 0128
    • Aichi
      • Nagoya-shi, Aichi, Japan, 4640021
        • Local Institution - 0135
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0124
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 8078556
        • Local Institution - 0129
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 6500047
        • Local Institution - 0127
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 9208641
        • Local Institution - 0144
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Local Institution - 0125
    • Miyagi
      • Sendai-shi, 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, Mexico, 31000
        • Local Institution - 0028
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Local Institution - 0077
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Local Institution - 0027
  • Netherlands
      • Groningen, Netherlands, 9700RB
        • Local Institution - 0004
      • Rotterdam, Netherlands, 3015 GD
        • Local Institution - 0003
  • Poland
    • Małopolskie
      • Kraków, Małopolskie, Poland, 31-202
        • Local Institution - 0049
  • Puerto Rico
      • Hato Rey, Puerto Rico, 00917
        • Local Institution - 0117
  • Romania
      • Bucuresti, Romania, 022328
        • Local Institution - 0011
      • Floresti, Romania, 407280
        • Local Institution - 0012
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Local Institution - 0013
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Local Institution
      • Saint-Petersburg, Russian Federation, 197758
        • Local Institution
      • St. Petersburg, Russian Federation, 198255
        • Local Institution
      • St. Petersburg, Russian Federation, 194291
        • Local Institution
  • Spain
      • Madrid, Spain, 28006
        • Local Institution - 0046
      • Majadahonda - Madrid, Spain, 28222
        • Local Institution - 0044
      • Valencia, Spain, 46026
        • Local Institution - 0045
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Local Institution - 0119
      • Kaohsiung City, Taiwan, 807
        • Local Institution - 0149
      • New Taipei City, Taiwan, 235
        • Local Institution - 0116
      • Taipei City, 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 - 0074
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0076
    • 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
Time Frame
Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR)
Time Frame: 5 Years from randomization
5 Years from randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Up to 5 years from randomization
Up to 5 years from randomization
Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR)
Time Frame: At the time of surgery, between week 12 to week 18
At the time of surgery, between week 12 to week 18
Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review
Time Frame: Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22
Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22
Incidence of Serious Adverse Events (SAEs)
Time Frame: Up to 80 weeks
Up to 80 weeks
Incidence of Adverse Events (AEs)
Time Frame: Up to 80 weeks
Up to 80 weeks

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)

September 30, 2024

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 (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

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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