Phase
Condition
Carcinoma
Treatment
Cisplatin
Carboplatin
Gemcitabine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
A patient must meet the following criteria to be eligible for inclusion in the study:
Patients with histologically or cytologically documented squamous or non squamousNSCLC with stage IIIB or stage IIIC disease who are not candidates for treatmentwith definitive concurrent chemoradiation or patients with stage IV disease whoreceived no prior systemic treatment for recurrent or metastatic NSCLC
Archival or newly obtained formalin-fixed tumor tissue from a metastatic/recurrentsite, which has not previously been irradiated
Tumor cells expressing PD L1 above a specific percentage of tumor cells by IHCperformed by the central laboratory
At least 1 radiographically measureable lesion per RECIST 1.1
ECOG performance status of ≤1
Anticipated life expectancy of at least 3 months
Adequate organ and bone marrow function
Exclusion
Key Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
Patients that have never smoked, defined as smoking <100 cigarettes in a lifetime
Active or untreated brain metastases or spinal cord compression
Patients with tumors tested positive for EGFR gene mutations, ALK genetranslocations, or ROS1 fusions
Encephalitis, meningitis, or uncontrolled seizures in the year prior torandomization
History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizingpneumonia) or active, noninfectious pneumonitis that required immune-suppressivedoses of glucocorticoids to assist with management. A history of radiationpneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6months prior to randomization
Patients with active, known, or suspected autoimmune disease that has requiredsystemic therapy in the past 2 years
Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day orequivalent) within 14 days of randomization
Another malignancy that is progressing or requires treatment
Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiencyvirus (HIV) or diagnosis of immunodeficiency
Active infection requiring systemic therapy within 14 days prior to randomization
Prior therapy with anti-PD 1 or anti-PD L1
Treatment-related immune-mediated AEs from immune-modulatory agents
Receipt of an investigational drug or device within 30 days
Receipt of a live vaccine within 30 days of planned start of study medication
Major surgery or significant traumatic injury within 4 weeks prior to first dose
Documented allergic or acute hypersensitivity reaction attributed to antibodytreatments
Known psychiatric or substance abuse disorder that would interfere withparticipation with the requirements of the study, including current use of anyillicit drugs
Pregnant or breastfeeding women
Women of childbearing potential or men who are unwilling to practice highlyeffective contraception prior to the initial dose/start of the first treatment,during the study, and for at least 6 months after the last dose
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Study Design
Study Description
Connect with a study center
Clinical Study Site
Albury, New South Wales
AustraliaSite Not Available
Clinical Study Site
Wollongong, New South Wales
AustraliaSite Not Available
Clinical Study Site
Fitzroy,
AustraliaSite Not Available
Clinical Study Site
Minsk,
BelarusSite Not Available
Clinical Study Site
Mogilev,
BelarusSite Not Available
Clinical Study Site 1
Porto Alegre, Rio Grande Do Sul
BrazilSite Not Available
Clinical Study Site
Barretos,
BrazilSite Not Available
Clinical Study Site
Curitiba,
BrazilSite Not Available
Clinical Study Site
Joinville,
BrazilSite Not Available
Clinical Study Site
Lajeado,
BrazilSite Not Available
Clinical Study Site
Mogi Das Cruzes,
BrazilSite Not Available
Clinical Study Site
Passo Fundo,
BrazilSite Not Available
Clinical Study Site
Pelotas,
BrazilSite Not Available
Clinical Study Site 2
Porto Alegre,
BrazilSite Not Available
Clinical Study Site 3
Porto Alegre,
BrazilSite Not Available
Clinical Study Site
Recife,
BrazilSite Not Available
Clinical Study Site
Rio De Janeiro,
BrazilSite Not Available
Clinical Study Site
Salvador,
BrazilSite Not Available
Clinical Study Site
Santa Cecília,
BrazilSite Not Available
Clinical Study Site #4
Sao Paulo,
BrazilSite Not Available
Clinical Study Site
São José Do Rio Preto,
BrazilSite Not Available
Clinical Study Site #3
São Paulo,
BrazilSite Not Available
Clinical Study Site 1
São Paulo,
BrazilSite Not Available
Clinical Study Site 2
São Paulo,
BrazilSite Not Available
Clinical Study Site
Dobrich,
BulgariaSite Not Available
Clinical Study Site
Gabrovo,
BulgariaSite Not Available
Clinical Study Site
Recoleta,
ChileSite Not Available
Clinical Study Site
Santiago,
ChileSite Not Available
Clinical Study Site
Temuco,
ChileSite Not Available
Clincial Study Site
Viña Del Mar,
ChileSite Not Available
Clinical Study Site
Lanshan, Shandong
ChinaSite Not Available
Clinical Study Site
Guangdong,
ChinaSite Not Available
Clinical Study Site
Harbin,
ChinaSite Not Available
Clinical Study Site
Linyi,
ChinaSite Not Available
Clinical Study Site 1
Shanghai,
ChinaSite Not Available
Clinical Study Site 2
Shanghai,
ChinaSite Not Available
Clinical Study Site 1
Tianjin,
ChinaSite Not Available
Clinical Study Site 2
Tianjin,
ChinaSite Not Available
Clinical Study Site
Xuzhou,
ChinaSite Not Available
Clinical Study Site
Zhejiang,
ChinaSite Not Available
Clinical Study Site
Barranquilla,
ColombiaSite Not Available
Clinical Study Site
Bogotá,
ColombiaSite Not Available
Clinical Study Site
Floridablanca,
ColombiaSite Not Available
Clinical Study Site
Nový Jičín,
CzechiaSite Not Available
Clinical Study Site
Pelhřimov,
CzechiaSite Not Available
Clinical Study Site
Prague,
CzechiaSite Not Available
Clinical Study Site
Praha,
CzechiaSite Not Available
Clinical Study Site
Batumi,
GeorgiaSite Not Available
Clinical Study Site #6
Tbilisi,
GeorgiaSite Not Available
Clinical Study Site 1
Tbilisi,
GeorgiaSite Not Available
Clinical Study Site 2
Tbilisi,
GeorgiaSite Not Available
Clinical Study Site 3
Tbilisi,
GeorgiaSite Not Available
Clinical Study Site 4
Tbilisi,
GeorgiaSite Not Available
Clinical Study Site 5
Tbilisi,
GeorgiaSite Not Available
Clinical Study Site
Patras, Achaia
GreeceSite Not Available
Clinical Study Site
Cholargós, Attiki
GreeceSite Not Available
Clinical Study Site 1
Athens,
GreeceSite Not Available
Clinical Study Site 2
Athens,
GreeceSite Not Available
Clinical Study Site 3
Athens,
GreeceSite Not Available
Clinical Study Site
Larissa,
GreeceSite Not Available
Clinical Study Site
Pylaía,
GreeceSite Not Available
Clinical Study Site 1
Thessaloníki,
GreeceSite Not Available
Clinical Study Site 2
Thessaloníki,
GreeceSite Not Available
Clinical Study Site 3
Thessaloníki,
GreeceSite Not Available
Clinical Study Site
Gyula, Bekes
HungarySite Not Available
Clinical Study Site
Tatabánya, Komarom-Esztergom
HungarySite Not Available
Clinical Study Site
Farkasgyepű, Veszprém
HungarySite Not Available
Clinical Study Site
Budapest,
HungarySite Not Available
Clinical Study Site
Debrecen,
HungarySite Not Available
Clinical Study Site
Zalaegerszeg,
HungarySite Not Available
Clinical Study Site
Amman,
JordanSite Not Available
Clinical Study Site
Irbid,
JordanSite Not Available
Clinical Study Site
Bsalîm,
LebanonSite Not Available
Clinical Study Site
Mazraat Ech Choûf,
LebanonSite Not Available
Clinical Study Site
Sidon,
LebanonSite Not Available
Clinical Study Site
Kampung Baharu Nilai,
MalaysiaSite Not Available
Clinical Study Site #1
Kuala Lumpur,
MalaysiaSite Not Available
Clinical Study Site #2
Kuala Lumpur,
MalaysiaSite Not Available
Clinical Study Site
Kuching,
MalaysiaSite Not Available
Clinical Study Site
Pulau Pinang,
MalaysiaSite Not Available
Clinical Study Site
Tanjong Bungah,
MalaysiaSite Not Available
Clinical Study Site
Coahuila,
MexicoSite Not Available
Clinical Study Site
Cuautitlán,
MexicoSite Not Available
Clinical Study Site
Jalisco,
MexicoSite Not Available
Clinical Study Site
León de los Aldama,
MexicoSite Not Available
Clinical Study Site 1
Monterrey,
MexicoSite Not Available
Clinical Study Site 2
Monterrey,
MexicoSite Not Available
Clinical Study Site 3
Monterrey,
MexicoSite Not Available
Clinical Study Site
Oaxaca,
MexicoSite Not Available
Clinical Study Site
San Luis Potosí,
MexicoSite Not Available
Clinical Study Site
Bacolod City,
PhilippinesSite Not Available
Clinical Study Site
Batangas,
PhilippinesSite Not Available
Clinical Study Site
Cebu,
PhilippinesSite Not Available
Clinical Study Site
Davao City,
PhilippinesSite Not Available
Clinical Study Site 1
Manila,
PhilippinesSite Not Available
Clinical Study Site 2
Manila,
PhilippinesSite Not Available
Clinical Study Site #1
Quezon City,
PhilippinesSite Not Available
Clinical Study Site #2
Quezon City,
PhilippinesSite Not Available
Clinical Study Site
Taguig,
PhilippinesSite Not Available
Clinical Study Site
Dąbrowa Górnicza,
PolandSite Not Available
Clinical Study Site
Gdynia,
PolandSite Not Available
Clinical Study Site
Kraków,
PolandSite Not Available
Clinical Study Site
Olsztyn,
PolandSite Not Available
Clinical Study Site
Poznań,
PolandSite Not Available
Clinical Study Site
Prabuty,
PolandSite Not Available
Clinical Study Site
Radom,
PolandSite Not Available
Clinical Study Site
Rzeszów,
PolandSite Not Available
Clinical Study Site
Toruń,
PolandSite Not Available
Clinical Study Site
Warszawa,
PolandSite Not Available
Clinical Study Site
Wodzisław Śląski,
PolandSite Not Available
Clinical Study Site
Łódź,
PolandSite Not Available
Clinical Study Site 1
Craiova,
RomaniaSite Not Available
Clinical Study Site 2
Craiova,
RomaniaSite Not Available
Clinical Study Site
Floreşti,
RomaniaSite Not Available
Clinical Study Site
Ploieşti,
RomaniaSite Not Available
Clinical Study Site
Timişoara,
RomaniaSite Not Available
Clinical Study Site
Ufa, Republic Bashkortost
Russian FederationSite Not Available
Clinical Study Site
Pushkin, Saint Petersburg
Russian FederationSite Not Available
Clinical Study Site
Arkhangel'sk,
Russian FederationSite Not Available
Clinical Study Site
Belgorod,
Russian FederationSite Not Available
Clinical Study Site
Chelyabinsk,
Russian FederationSite Not Available
Clinical Study Site
Kaluga,
Russian FederationSite Not Available
Clinical Study Site
Kazan,
Russian FederationSite Not Available
Clinical Study Site
Kemerovo,
Russian FederationSite Not Available
Clinical Study Site
Kislino,
Russian FederationSite Not Available
Clinical Study Site
Kursk,
Russian FederationSite Not Available
Clinical Study Site 1
Moscow,
Russian FederationSite Not Available
Clinical Study Site 2
Moscow,
Russian FederationSite Not Available
Clinical Study Site 3
Moscow,
Russian FederationSite Not Available
Clinical Study Site
Omsk,
Russian FederationSite Not Available
Clinical Study Site
Pyatigorsk,
Russian FederationSite Not Available
Clinical Study Site 1
Saint Petersburg,
Russian FederationSite Not Available
Clinical Study Site 2
Saint Petersburg,
Russian FederationSite Not Available
Clinical Study Site 3
Saint Petersburg,
Russian FederationSite Not Available
Clinical Study Site 4
Saint Petersburg,
Russian FederationSite Not Available
Clinical Study Site
Samara,
Russian FederationSite Not Available
Clinical Study Site
Saransk,
Russian FederationSite Not Available
Clinical Study Site
Sochi,
Russian FederationSite Not Available
Clinical Study Site 1
Tomsk,
Russian FederationSite Not Available
Clinical Study Site 2
Tomsk,
Russian FederationSite Not Available
Clinical Study Site
Yekaterinburg,
Russian FederationSite Not Available
Clinical Study Site
Manresa, Barcelona
SpainSite Not Available
Clinical Study Site
Barcelona,
SpainSite Not Available
Clinical Study Site
Pamplona,
SpainSite Not Available
Clinical Study Site
Chang Hua,
TaiwanSite Not Available
Clinical Study Site
Hualien City,
TaiwanSite Not Available
Clinical Study Site 1
Kaohsiung,
TaiwanSite Not Available
Clinical Study Site 2
Kaohsiung,
TaiwanSite Not Available
Clinical Study Site 2
New Taipei,
TaiwanSite Not Available
Clinical Study Site 1
New Taipei City,
TaiwanSite Not Available
Clinical Study Site 1
Taichung,
TaiwanSite Not Available
Clinical Study Site 2
Taichung,
TaiwanSite Not Available
Clinical Study Site 1
Taipei,
TaiwanSite Not Available
Clinical Study Site 2
Taipei,
TaiwanSite Not Available
Clinical Study Site 3
Taipei,
TaiwanSite Not Available
Clinical Study Site
Lop Buri, Muang
ThailandSite Not Available
Clinical Study Site
Hat Yai, Songkhla
ThailandSite Not Available
Clinical Study Site #1
Bangkok,
ThailandSite Not Available
Clinical Study Site #2
Bangkok,
ThailandSite Not Available
Clinical Study Site
Chiang Rai,
ThailandSite Not Available
Clinical Study Site
Khon Kaen,
ThailandSite Not Available
Clinical Study Site
Lampang,
ThailandSite Not Available
Clinical Study Site
Phitsanulok,
ThailandSite Not Available
Clinical Study Site
Ratchathewi,
ThailandSite Not Available
Clinical Study Site
Udon Thani,
ThailandSite Not Available
Clinical Study Site 1
Adana,
TurkeySite Not Available
Clinical Study Site 2
Adana,
TurkeySite Not Available
Clinical Study Site 1
Ankara,
TurkeySite Not Available
Clinical Study Site 2
Ankara,
TurkeySite Not Available
Clinical Study Site 3
Ankara,
TurkeySite Not Available
Clinical Study Site 4
Ankara,
TurkeySite Not Available
Clinical Study Site 5
Ankara,
TurkeySite Not Available
Clinical Study Site
Edirne,
TurkeySite Not Available
Clinical Study Site 1
Istanbul,
TurkeySite Not Available
Clinical Study Site 2
Istanbul,
TurkeySite Not Available
Clinical Study Site 3
Istanbul,
TurkeySite Not Available
Clinical Study Site 4
Istanbul,
TurkeySite Not Available
Clinical Study Site
Samsun,
TurkeySite Not Available
Clinical Study Site 1
İzmir,
TurkeySite Not Available
Clinical Study Site 2
İzmir,
TurkeySite Not Available
Clinical Study Site 3
İzmir,
TurkeySite Not Available
Clinical Study Site
Dnepropetrovsk,
UkraineSite Not Available
Clinical Study Site
Ivano-Frankivs'k,
UkraineSite Not Available
Clinical Study Site
Kharkiv,
UkraineSite Not Available
Clinical Study Site
Kherson,
UkraineSite Not Available
Clinical Study Site 1
Kiev,
UkraineSite Not Available
Clinical Study Site 2
Kiev,
UkraineSite Not Available
Clinical Study Site
Kirovohrad,
UkraineSite Not Available
Clinical Study Site 1
Kyiv,
UkraineSite Not Available
Clinical Study Site 2
Kyiv,
UkraineSite Not Available
Clinical Study Site
Vinnytsia,
UkraineSite Not Available
Clinical Study Site
Zaporozhye,
UkraineSite Not Available
Clinical Study Site
Úzhgorod,
UkraineSite Not Available

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