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
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Biological: NivolumabDrug: Placebo
- Registration Number
- NCT04025879
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 461
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. Placebo - Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo Nivolumab - Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. Carboplatin - Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo Docetaxel - Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo Cisplatin - Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo Paclitaxel - Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo Carboplatin - Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo Pemetrexed - Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. Cisplatin - Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. Paclitaxel - Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. Docetaxel - Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac. Pemetrexed -
- Primary Outcome Measures
Name Time Method Event-Free Survival (EFS) by BICR 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
- Secondary Outcome Measures
Name Time Method Major Pathological Response (MPR) Rate 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).
Overall Survival (OS) 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.
Pathologic Complete Response (pCR) Rate 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).
The Number of Participants With Adverse Events (AEs) 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.
The Number of Participants With Serious Adverse Events (SAEs) 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.
The Number of Participants With Select Adverse Events (AEs) 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.
Trial Locations
- Locations (105)
Local Institution - 0086
🇺🇸Traverse City, Michigan, United States
Local Institution - 0103
🇺🇸Fredericksburg, Virginia, United States
Local Institution - 0062
🇨🇦Oshawa, Ontario, Canada
Local Institution - 0074
🇺🇸Boston, Massachusetts, United States
Local Institution - 0133
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution
🇷🇺St. Petersburg, Russian Federation
Local Institution - 0119
🇨🇳Kaohsiung, Taiwan
Local Institution - 0129
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0144
🇯🇵Kanazawa-shi, Ishikawa, Japan
Local Institution - 0125
🇯🇵Yokohama, Kanagawa, Japan
Local Institution - 0012
🇷🇴Floresti, Romania
Local Institution - 0116
🇨🇳New Taipei City, Taiwan
Local Institution - 0036
🇧🇷Sao Paulo, São Paulo, Brazil
Local Institution - 0124
🇯🇵Kashiwa-shi, Chiba, Japan
Local Institution - 0127
🇯🇵Kobe-shi, Hyogo, Japan
Local Institution - 0032
🇦🇷Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina
Local Institution - 0031
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0002
🇧🇪Edegem, Belgium
Local Institution - 0135
🇯🇵Nagoya-shi, Aichi, Japan
Local Institution - 0134
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0049
🇵🇱Kraków, Małopolskie, Poland
Rcca Md Llc
🇺🇸Bethesda, Maryland, United States
Local Institution - 0121
🇺🇸Orland Park, Illinois, United States
Local Institution - 0104
🇺🇸Tampa, Florida, United States
Local Institution - 0040
🇺🇸Atlanta, Georgia, United States
Local Institution - 0145
🇺🇸Chicago, Illinois, United States
Local Institution - 0076
🇺🇸Boston, Massachusetts, United States
Local Institution - 0100
🇺🇸Lebanon, New Hampshire, United States
Local Institution - 0055
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0102
🇺🇸Cleveland, Ohio, United States
Local Institution - 0043
🇦🇷Buenos Aires, Argentina
Local Institution - 0030
🇦🇷Caba, Argentina
Local Institution - 0033
🇦🇺Heidelberg, Victoria, Australia
Local Institution - 0023
🇦🇺North Ballarat, Victoria, Australia
Local Institution - 0029
🇧🇷Ijui, RIO Grande DO SUL, Brazil
Local Institution - 0005
🇧🇪Liege, Belgium
Local Institution - 0034
🇧🇷São Paulo, SAO Paulo, Brazil
Local Institution - 0106
🇧🇷São Paulo, Brazil
Local Institution - 0137
🇨🇳Fuzhou, Fujian, China
Local Institution - 0096
🇨🇳Beijing, BEI, China
Local Institution - 0136
🇨🇳Fuzhou, Fujian, China
Local Institution - 0151
🇨🇳Hubei Sheng, Hubei, China
Local Institution - 0093
🇨🇳Changsha, Hunan, China
Local Institution - 0092
🇨🇳Changsha, Hunan, China
Local Institution - 0091
🇨🇳Changsha, Hunan, China
Local Institution - 0098
🇨🇳Shanghai, Shanghai, China
Local Institution - 0165
🇨🇳Shanghai, Shanghai, China
Local Institution - 0113
🇨🇳Shanghai, Shanghai, China
Local Institution - 0099
🇨🇳Hangzhou, Zhejiang, China
Local Institution - 0095
🇨🇳Shanghai, China
Local Institution - 0073
🇫🇷Besancon, France
Local Institution - 0041
🇨🇿Praha 2, Czechia
Local Institution - 0042
🇨🇿Praha 4, Czechia
Local Institution - 0050
🇫🇷Montpellier, France
Local Institution - 0037
🇫🇷La Tronche, France
Local Institution - 0038
🇫🇷Paris Cedex 18, France
Local Institution - 0083
🇫🇷Rennes Cedex 9, France
Local Institution - 0085
🇩🇪Berlin, Germany
Local Institution - 0065
🇩🇪Frankfurt, Germany
Local Institution - 0071
🇩🇪Hamm, Germany
Local Institution - 0108
🇩🇪Heidelberg, Germany
Local Institution - 0109
🇩🇪Immenstadt, Germany
Local Institution - 0147
🇩🇪Ludwigsburg, Germany
Local Institution - 0066
🇩🇪Muenchen, Germany
Local Institution - 0063
🇩🇪Luebeck, Germany
Local Institution - 0070
🇩🇪Moers, Germany
Local Institution - 0064
🇩🇪Loewenstein, Germany
Local Institution - 0016
🇮🇪Dublin, Ireland
Local Institution - 0024
🇮🇹Forlì, Italy
Local Institution - 0026
🇮🇹Milano, Italy
Azienda Ospedaliera Di Parma
🇮🇹Parma, Italy
Local Institution - 0131
🇯🇵Sendai-shi, Miyagi, Japan
Local Institution - 0126
🇯🇵Sakai-shi, Osaka, Japan
Local Institution - 0130
🇯🇵Kitaadachigun, Saitama, Japan
Local Institution - 0142
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0143
🇯🇵Chuo-ku, Tokyo, Japan
Local Institution - 0132
🇯🇵Fukushima-shi, Japan
Local Institution - 0077
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0128
🇯🇵Hiroshima, Japan
Local Institution - 0028
🇲🇽Chihuahua, Mexico
Local Institution - 0027
🇲🇽Monterrey, Nuevo Leon, Mexico
Local Institution - 0004
🇳🇱Groningen, Netherlands
Local Institution - 0003
🇳🇱Rotterdam, Netherlands
Local Institution - 0117
🇵🇷Hato Rey, Puerto Rico
Local Institution - 0013
🇷🇴Cluj-Napoca, Cluj, Romania
Local Institution - 0011
🇷🇴Bucuresti, Romania
Local Institution - 0149
🇨🇳Kaohsiung City, Taiwan
Local Institution - 0112
🇨🇳Taipei City, Taiwan
Local Institution - 0046
🇪🇸Madrid, Spain
Local Institution - 0044
🇪🇸Majadahonda - Madrid, Spain
Local Institution - 0045
🇪🇸Valencia, Spain
Local Institution - 0007
🇬🇧Taunton, United Kingdom
Local Institution - 0120
🇺🇸Augusta, Georgia, United States
Local Institution - 0078
🇺🇸Chicago, Illinois, United States
Local Institution - 0051
🇫🇷Paris Cedex 20, France
Local Institution - 0122
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0001
🇧🇪Roeselare, Belgium
Local Institution - 0035
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0115
🇨🇳Beijing, Beijing, China
Local Institution - 0088
🇨🇳Chengdu, Sichuan, China
Local Institution - 0110
🇩🇪Köln, Nordrhein-Westfalen, Germany
Local Institution - 0146
🇫🇷Rouen, France
Local Institution - 0072
🇩🇪Georgsmarienhuette, Germany
Local Institution - 0054
🇺🇸Houston, Texas, United States
Local Institution - 0020
🇦🇺Sydney, New South Wales, Australia