Clincosm LogoSign in Get a demo

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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04025879
Collaborator
(none)
452
Enrollment
128
Locations
2
Arms
58.8
Anticipated Duration (Months)
3.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
452 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 5, 2019
Anticipated Primary Completion Date :
Dec 10, 2023
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

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: 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: Placebo
    Specified dose on specified days

    Drug: Docetaxel
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR) [5 Years from randomization]

    Secondary Outcome Measures

    1. Overall Survival (OS) [Up to 5 years from randomization]

    2. Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR) [At the time of surgery, between week 12 to week 18]

    3. Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review [Up to 8 weeks following completion of neoadjuvant surgery, approximately study week 22]

    4. Incidence of Serious Adverse Events (SAEs) [Up to 80 weeks]

    5. Incidence of Adverse Events (AEs) [Up to 80 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution Fresno California United States 93703
    2 Local Institution - 0104 Tampa Florida United States 33612
    3 Local Institution - 0040 Atlanta Georgia United States 30342
    4 Local Institution - 0120 Augusta Georgia United States 30912
    5 Local Institution - 0145 Chicago Illinois United States 60611
    6 Local Institution - 0078 Chicago Illinois United States 60612
    7 Local Institution - 0121 Orland Park Illinois United States 60462
    8 Local Institution Westwood Kansas United States 66205
    9 Rcca Md Llc Bethesda Maryland United States 20817
    10 Local Institution - 0074 Boston Massachusetts United States 02215
    11 Massachusetts General Hospital Boston Massachusetts United States 02215
    12 Munson Medical Center Traverse City Michigan United States 49684
    13 Local Institution - 0100 Lebanon New Hampshire United States 03756
    14 Local Institution - 0055 Cincinnati Ohio United States 45220
    15 Local Institution Cincinnati Ohio United States 45267-0558
    16 Local Institution - 0102 Cleveland Ohio United States 44106
    17 Thomas Jefferson University - Clinical Trials Office-Medical Oncology Philadelphia Pennsylvania United States 19107
    18 Local Institution - 0054 Houston Texas United States 77030
    19 Local Institution - 0103 Fredericksburg Virginia United States 22408
    20 Local Institution - 0032 Ciudad Autonoma Beunos Aires Buenos Aires Argentina 1431
    21 Local Institution - 0043 Buenos Aires Argentina CP1280AEB
    22 Local Institution - 0031 Caba Argentina 1199
    23 Local Institution - 0030 Caba Argentina 1426
    24 Local Institution - 0020 Sydney New South Wales Australia 2050
    25 Local Institution Greenslopes Queensland Australia 4120
    26 Local Institution - 0033 Heidelberg Victoria Australia 3084
    27 St Vincent's Hospital Melbourne Victoria Australia 3065
    28 Local Institution - 0023 North Ballarat Victoria Australia 33500
    29 Local Institution - 0002 Edegem Belgium 2650
    30 Local Institution - 0005 Liege Belgium 4000
    31 Local Institution - 0001 Roeselare Belgium 8800
    32 Local Institution Fortaleza Ceara Brazil 60430-230
    33 Local Institution - 0035 Belo Horizonte Minas Gerais Brazil 30130-090
    34 Local Institution - 0029 Ijui RIO Grande DO SUL Brazil 98700-000
    35 Local Institution - 0106 São Paulo SAO Paulo Brazil 01321-001
    36 Local Institution - 0034 São Paulo SAO Paulo Brazil 05652-900
    37 Local Institution - 0036 Sao Paulo Brazil 01509-010
    38 Local Institution - 0062 Oshawa Ontario Canada L1G 2B9
    39 Local Institution Windsor Ontario Canada N8W 2X3
    40 Local Institution Greenfield Park Quebec Canada J4V 2H1
    41 Local Institution Montreal Quebec Canada H2L 4M1
    42 Local Institution Montreal Quebec Canada H2X 0A9
    43 Local Institution Montreal Quebec Canada H3T 1M5
    44 Local Institution - 0115 Beijing Beijing China 100021
    45 Local Institution Beijing BEI China 100142
    46 Local Institution - 0137 Fuzhou Fujian China 350001
    47 Local Institution - 0136 Fuzhou Fujian China 350014
    48 Local Institution - 0151 Hubei Sheng Hubei China 430079
    49 Local Institution - 0092 Changsha Hunan China 410000
    50 Local Institution - 0093 Changsha Hunan China 410000
    51 Local Institution - 0091 Changsha Hunan China 410008
    52 Local Institution - 0152 Changchun Jilin China 130021
    53 Local Institution - 0098 Shanghai Shanghai China 200010
    54 Local Institution - 0165 Shanghai Shanghai China 200030
    55 Local Institution - 0113 Shanghai Shanghai China 200433
    56 Local Institution - 0088 Chengdu Sichuan China 610041
    57 Local Institution - 0099 Hangzhou Zhejiang China 310016
    58 Local Institution - 0095 Shanghai China 200032
    59 Local Institution - 0041 Praha 2 Czechia 128 08
    60 Local Institution - 0042 Praha 4 Czechia 140 59
    61 Chu Jean Minjoz Besancon France 25030
    62 Local Institution - 0037 La Tronche France 38700
    63 Local Institution - 0050 Montpellier France 34295
    64 Local Institution Paris Cedex 18 France 75018
    65 Local Institution - 0051 Paris Cedex 20 France 75970
    66 Local Institution - 0083 Rennes Cedex 9 France 35033
    67 Local Institution - 0146 Rouen France 76000
    68 Local Institution - 0085 Berlin Germany 13353
    69 Local Institution - 0110 Cologne Germany 51109
    70 Local Institution - 0065 Frankfurt Germany 60488
    71 Local Institution - 0072 Georgsmarienhuette Germany 49124
    72 Local Institution - 0071 Hamm Germany 59063
    73 Local Institution - 0108 Heidelberg Germany 69126
    74 Local Institution - 0109 Immenstadt Germany 87509
    75 Local Institution - 0064 Loewenstein Germany 74245
    76 Local Institution - 0147 Ludwigsburg Germany 71640
    77 Local Institution - 0063 Luebeck Germany 23538
    78 Local Institution - 0070 Moers Germany 47441
    79 Local Institution - 0066 Muenchen Germany 81675
    80 Local Institution Dublin 7 Dublin Ireland
    81 Local Institution - 0016 Dublin Ireland D24 DH74
    82 IRST Meldola Forlì Italy 47014
    83 Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milano Italy 20122
    84 Azienda Ospedaliera Di Parma Parma Italy 43126
    85 Local Institution - 0135 Nagoya-shi Aichi Japan 4640021
    86 Local Institution - 0124 Kashiwa-shi Chiba Japan 2778577
    87 Local Institution - 0129 Kitakyushu-shi Fukuoka Japan 8078556
    88 Local Institution - 0127 Kobe-shi Hyogo Japan 6500047
    89 Local Institution - 0144 Kanazawa-shi Ishikawa Japan 9208641
    90 Local Institution - 0125 Yokohama Kanagawa Japan 241-8515
    91 Local Institution - 0131 Sendai-shi Miyagi Japan 9800873
    92 Local Institution - 0126 Sakai-shi Osaka Japan 5918555
    93 Local Institution - 0130 Kitaadachigun Saitama Japan 3620806
    94 Local Institution - 0142 Bunkyo-ku Tokyo Japan 1138431
    95 Local Institution - 0133 Bunkyo-ku Tokyo Japan 1138603
    96 Local Institution - 0143 Chuo-ku Tokyo Japan 1040045
    97 Local Institution - 0134 Chuo-ku Tokyo Japan 5418567
    98 Local Institution - 0132 Fukushima-shi Japan 960-1295
    99 Local Institution - 0128 Hiroshima Japan 734-8551
    100 Local Institution - 0077 Guadalajara Jalisco Mexico 44280
    101 Local Institution - 0027 Monterrey Nuevo Leon Mexico 64460
    102 Local Institution - 0028 Chihuahua Mexico 31000
    103 Local Institution - 0004 Groningen Netherlands 9700RB
    104 Local Institution - 0003 Rotterdam Netherlands 3015 GD
    105 Local Institution - 0049 Kraków Małopolskie Poland 31-202
    106 Local Institution - 0117 Hato Rey Puerto Rico 00917
    107 Local Institution San Juan Puerto Rico 917
    108 Local Institution - 0013 Cluj-Napoca Cluj Romania 400015
    109 Local Institution - 0011 Bucuresti Romania 022328
    110 Local Institution - 0012 Floresti Romania 407280
    111 Local Institution Krasnodar Russian Federation 350086
    112 Local Institution Moscow Russian Federation 115478
    113 Local Institution Saint-Petersburg Russian Federation 197758
    114 Local Institution St. Petersburg Russian Federation 194291
    115 Local Institution St. Petersburg Russian Federation 198255
    116 Local Institution Barcelona Spain 08035
    117 Local Institution L'Hospitalet Spain 08907
    118 Local Institution - 0046 Madrid Spain 28006
    119 Local Institution - 0044 Majadahonda - Madrid Spain 28222
    120 Local Institution - 0045 Valencia Spain 46026
    121 Local Institution Kaohsiung City Taiwan 807
    122 Local Institution - 0119 Kaohsiung Taiwan 833
    123 Local Institution New Taipei City Taiwan 235
    124 Local Institution - 0112 Taipei City Taiwan 100225
    125 Local Institution Ipswich Suffolk United Kingdom IP4 5PD
    126 Local Institution Exeter United Kingdom EX2 5DW
    127 Local Institution Guildford United Kingdom GU2 7XX
    128 Local Institution - 0007 Taunton United Kingdom TA1 5DA

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT04025879
    Other Study ID Numbers:
    • CA209-77T
    • 2019-000262-38
    First Posted:
    Jul 19, 2019
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Paclitaxel
    Docetaxel
    Carboplatin
    Nivolumab
    Pemetrexed

    Study Results

    No Results Posted as of Aug 22, 2022