Phase
Condition
Non-small Cell Lung Cancer
Lung Disease
Lung Cancer
Treatment
Nivolumab
Cisplatin
Nab-paclitaxel
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
All Substudies:
Histologically or cytologically documented non-small-cell lung cancer (NSCLC).
No known actionable genomic alterations for which targeted therapies are available.
Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
Measurable disease per response evaluation criteria in solid tumors.
Adequate hematologic and end-organ function.
Individuals of childbearing potential who engage in heterosexual intercourse mustagree to use specified method(s) of contraception.
Substudy 01: All Experimental arms
Stage IV NSCLC.
For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR)or anaplastic lymphoma kinase (ALK) alteration negative.
PD-L1 status by central confirmation.
No prior systemic treatment for metastatic NSCLC.
Substudy 02: All Experimental arms
Stage IV NSCLC.
In individuals with nonsquamous histology and actionable EGFR, ALK, or other knowngenomic alterations must have received treatment with at least 1 targeted therapy tothe appropriate genomic alteration.
Substudy 03: All Experimental arms
Previously untreated individuals with resectable (Stage II, IIIA, IIIB (T[3-4]N2)NSCLC (per American Joint Committee on Cancer (AJCC) Edition 8).
Planned surgery must comprise of lobectomy, sleeve lobectomy, or bi-lobectomy.
PD-L1 status by central confirmation.
For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR)or anaplastic lymphoma kinase (ALK) alteration negative.
Exclusion
Key Exclusion Criteria:
All Substudies:
Mixed small-cell lung cancer and NSCLC histology.
Active second malignancy.
Active autoimmune disease.
History of or current non-infectious pneumonitis/interstitial lung disease.
Active serious infection within 4 weeks prior to study treatment.
Substudy 01 and 02
Known active central nervous system (CNS) metastases and/or carcinomatousmeningitis.
Received previous anticancer therapy within 4 weeks prior to enrollment.
Substudy 03: All Experimental arms
NSCLC previously treated with systemic therapy or radiotherapy.
Received prior treatment with any anti-PD-(L)-1 or other immune checkpointinhibitors (CPIs).
Note: Other protocol defined inclusion/exclusion criteria may apply
Study Design
Connect with a study center
Centro Gaúcho Integrado de Oncologia Hematologia, Ensino e Pesquisa Ltda./Hospital Mãe de Deus,Substudy-03
Porto Alegre, 90110-270
BrazilActive - Recruiting
Hospital Mae de Deus
Porto Alegre, 90110-270
BrazilActive - Recruiting
Hospital Sao Lucas da PUC Rio Grande do Sul,Substudy-03
Porto Alegre, 90610001
BrazilActive - Recruiting
Fundação Antonio Prudente/A.C. Camargo Cancer Center,Substudy-03
São Paulo, 1509
BrazilActive - Recruiting
Real e Benemérita Associação Portuguesa de Beneficência/Hospital Beneficência Portuguesa de São Paulo (Hospital BP),Substudy-03
São Paulo, 1509
BrazilActive - Recruiting
Queen Elizabeth Hospital,Substudy-01
Hong Kong,
Hong KongActive - Recruiting
Queen Elizabeth Hospital,Substudy-02
Hong Kong,
Hong KongSite Not Available
Queen Mary Hospital,Substudy-01
Hong Kong, 999077
Hong KongActive - Recruiting
Queen Mary Hospital,Substudy-02
Hong Kong, 999077
Hong KongActive - Recruiting
Prince of Wales Hospital,Substudy-01
New Territories,
Hong KongActive - Recruiting
Prince of Wales Hospital,Substudy-02
New Territories,
Hong KongActive - Recruiting
Rambam Health Care Campus,Substudy-01
Haifa, 3525408
IsraelActive - Recruiting
Rambam Health Care Campus,Substudy-02
Haifa, 3525408
IsraelSite Not Available
Rambam Health Care Campus,Substudy-03
Haifa, 3525408
IsraelActive - Recruiting
Hadassah University Medical Center,Substudy-03
Jerusalem, 91120
IsraelActive - Recruiting
Shaare Zedek Medical Center,Substudy-01
Jerusalem, 9103102
IsraelActive - Recruiting
Shaare Zedek Medical Center,Substudy-02
Jerusalem, 9103102
IsraelSite Not Available
Shaare Zedek Medical Center,Substudy-03
Jerusalem, 9103102
IsraelActive - Recruiting
Rabin Medical Center,Substudy-03
Petah Tiqva, 49100
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center,Substudy-01
Tel Aviv-Yafo, 64239
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center,Substudy-02
Tel Aviv-Yafo, 64239
IsraelSite Not Available
Tel-Aviv Sourasky Medical Center,Substudy-03
Tel Aviv-Yafo, 64239
IsraelActive - Recruiting
Chungbuk National University Hospital,Substudy-01
Cheongju-si, 28644
Korea, Republic ofActive - Recruiting
Chungbuk National University Hospital,Substudy-02
Cheongju-si, 28644
Korea, Republic ofActive - Recruiting
Chungbuk National University Hospital,Substudy-01
Cheongjusi, 28644
Korea, Republic ofSite Not Available
Chungbuk National University Hospital,Substudy-02
Cheongjusi, 28644
Korea, Republic ofActive - Recruiting
National Cancer Center,Substudy-01
Goyang, 410769
Korea, Republic ofActive - Recruiting
National Cancer Center,Substudy-02
Goyang, 410769
Korea, Republic ofSite Not Available
National Cancer Center,Substudy-03
Goyang, 410769
Korea, Republic ofActive - Recruiting
Chonnam National University Hwasun Hospital,Substudy-01
Gwangju, 61469
Korea, Republic ofActive - Recruiting
Chonnam National University Hwasun Hospital,Substudy-03
Gwangju, 61469
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital,Substudy-01
Gyeonggi-do, 463-707
Korea, Republic ofActive - Recruiting
Seoul National University Bundang Hospital,Substudy-03
Gyeonggi-do, 463-707
Korea, Republic ofActive - Recruiting
Kosin University Gospel Hospital,Substudy-01
Seo-gu, 49267
Korea, Republic ofActive - Recruiting
Kosin University Gospel Hospital,Substudy-03
Seo-gu, 49267
Korea, Republic ofActive - Recruiting
Asan Medical Center,Substudy-02
Seoul, 05505
Korea, Republic ofSite Not Available
Asan Medical Center,Substudy-03
Seoul, 05505
Korea, Republic ofActive - Recruiting
Asan Medical Centre,Substudy-01
Seoul, 05505
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital,Substudy-01
Seoul, 8308
Korea, Republic ofActive - Recruiting
Korea University Guro Hospital,Substudy-03
Seoul, 8308
Korea, Republic ofActive - Recruiting
Samsung Medical Center,Substudy-01
Seoul, 06351
Korea, Republic ofActive - Recruiting
Samsung Medical Center,Substudy-02
Seoul, 06351
Korea, Republic ofSite Not Available
Samsung Medical Center,Substudy-03
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University,Substudy-01
Seoul, 463-707
Korea, Republic ofSite Not Available
Seoul National University,Substudy-02
Seoul, 463-707
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System,Substudy-01
Seoul, 120-752
Korea, Republic ofActive - Recruiting
Severance Hospital, Yonsei University Health System,Substudy-02
Seoul, 120-752
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System,Substudy-03
Seoul, 03722
Korea, Republic ofActive - Recruiting
Changhua Christian Hospital,Substudy-01
Changhua City, 500-06
TaiwanActive - Recruiting
Changhua Christian Hospital,Substudy-02
Changhua City, 500-06
TaiwanSite Not Available
Changhua Christian Hospital,Substudy-03
Changhua City, 500-06
TaiwanActive - Recruiting
Kaohsiung Chang Gung Memorial Hospital,Substudy-01
Kaohsiung, 83301
TaiwanActive - Recruiting
Kaohsiung Chang Gung Memorial Hospital,Substudy-02
Kaohsiung, 83301
TaiwanSite Not Available
Kaohsiung Chang Gung Memorial Hospital,Substudy-03
Kaohsiung, 83301
TaiwanActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-01
Kaohsiung City, 80756
TaiwanActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-02
Kaohsiung City, 80756
TaiwanActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital,Substudy-03
Kaohsiung City, 80756
TaiwanActive - Recruiting
National Taiwan University Hospital,Substudy-01
Taipei City, 100
TaiwanActive - Recruiting
National Taiwan University Hospital,Substudy-02
Taipei City, 100
TaiwanSite Not Available
Memorial Ankara Hospital,Substudy-03
Ankara, 06520
TurkeyActive - Recruiting
Dicle University Medical Faculty,Substudy-03
Diyarbakir, 21280
TurkeyActive - Recruiting
Necmettin Erbakan Universitesi,Substudy-03
Meram Konya, 42080
TurkeyActive - Recruiting
Birmingham Heartlands Hospital,Substudy-03
Birmingham, B9 5SS
United KingdomActive - Recruiting
University Hospitals Birmingham NHS Trust,Substudy-01
Birmingham, B9 5SS
United KingdomActive - Recruiting
University Hospitals Birmingham NHS Trust,Substudy-02
Birmingham, B9 5SS
United KingdomActive - Recruiting
St James University Hospital,,Substudy-01
Leeds, LS9 7TF
United KingdomActive - Recruiting
St. Bartholomew's Hospital,Substudy-01
London, E1 1BB
United KingdomActive - Recruiting
St. Bartholomew's Hospital,Substudy-02
London, E1 1BB
United KingdomActive - Recruiting
St. Bartholomew's Hospital,Substudy-03
London, E1 1BB
United KingdomActive - Recruiting
Arizona Oncology Associates,Substudy-01
Tucson, Arizona 85711
United StatesSite Not Available
Arizona Oncology Associates,Substudy-02
Tucson, Arizona 85711
United StatesActive - Recruiting
Rocky Mountain Cancer Center,Substudy-01
Denver, Colorado 80218
United StatesSite Not Available
Rocky Mountain Cancer Center,Substudy-02
Denver, Colorado 80218
United StatesActive - Recruiting
Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03
Fort Wayne, Indiana 46845
United StatesActive - Recruiting
Baptist Health Lexington,Substudy-03
Lexington, Kentucky 40503
United StatesActive - Recruiting
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Washington University School of Medicine - Siteman Cancer Center,Substudy-01
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Washington University School of Medicine - Siteman Cancer Center,Substudy-02
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine - Siteman Cancer Center,Substudy-03
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Oncology Hematology Care Clinical Trials, LLC,Substudy-01
Cincinnati, Ohio 45242
United StatesActive - Recruiting
Oncology Hematology Care Clinical Trials, LLC,Substudy-02
Cincinnati, Ohio 45242
United StatesActive - Recruiting
Oncology Associates of Oregon, PC,Substudy-01
Eugene, Oregon 97401
United StatesActive - Recruiting
Oncology Associates of Oregon, PC,Substudy-02
Eugene, Oregon 97401
United StatesActive - Recruiting
Texas Oncology - Central South,Substudy-01
Austin, Texas 78745
United StatesSite Not Available
Texas Oncology - Central South,Substudy-02
Austin, Texas 78745
United StatesActive - Recruiting
Texas Oncology,Substudy-01
Austin, Texas 78745
United StatesActive - Recruiting
Texas Oncology,Substudy-02
Austin, Texas 78745
United StatesActive - Recruiting
US Oncology Investigational Products Center (IPC),Substudy-01
Fairfax, Virginia 22031
United StatesSite Not Available
US Oncology Investigational Products Center (IPC),Substudy-02
Fairfax, Virginia 22031
United StatesActive - Recruiting
Fred Hutchinson Cancer Center,Substudy-01
Seattle, Washington 98109
United StatesActive - Recruiting
Fred Hutchinson Cancer Center,Substudy-02
Seattle, Washington 98109
United StatesActive - Recruiting
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