Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically documented, locally advanced or metastatic NSCLC
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or atleast 12 unstained, freshly cut serial sections with associated pathology report thatare evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR)mutation status prior to enrollment, except for known sensitizing EGFR mutations inwhich case 10 unstained slides are required and there is no need for central testingof EGFR mutation status
- Disease progression during or following treatment with a prior platinum-containingregimen for locally advanced, unresectable, inoperable, or metastatic NSCLC, ordisease recurrence within 6 months of treatment with a platinum-based adjuvant and/orneoadjuvant regimen or combined modality with curative intent
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than or equal to (>/=) 12 weeks
- Adequate hematologic and end organ function
- Agreement to remain abstinent or use contraceptive methods among women of childbearingpotential or male partners of women of childbearing potential
- Recovery from all acute toxicities from previous therapy
Exclusion
Exclusion Criteria:
- Active or untreated central nervous system (CNS) metastases
- Spinal cord compression not definitively treated or not clinically stable
- Leptomeningeal disease
- Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
- Uncontrolled tumor-related pain
- Uncontrolled hypercalcemia
- Malignancies other than NSCLC within 5 years prior to randomization, except for thosecuratively treated with negligible risk of metastasis or death
- Pregnant or lactating women
- Significant cardiovascular, pulmonary, or autoimmune disease
- Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2weeks prior to randomization
- Prior treatment with or hypersensitivity to study drug(s) or related compounds
- Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors
- Prior allogeneic bone marrow or solid organ transplant
- Known PD-L1-negative expression status
- Positive human immunodeficiency virus (HIV) or active hepatitis B or C
- Receipt of a live attenuated vaccine within 4 weeks prior to randomization
- Treatment with systemic immunomodulators within 4 weeks or five half-lives (whicheveris shorter) prior to randomization
- Treatment with systemic corticosteroids within 2 weeks prior to randomization
Study Design
Connect with a study center
Beijing Cancer Hospital
Beijing, 100142
ChinaSite Not Available
Beijing Chest Hospital; Oncology Department
Beijing, 101149
ChinaSite Not Available
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021
ChinaSite Not Available
Affiliated Hospital of Bengbu Medical College
Bengbu, 233004
ChinaSite Not Available
Jilin Cancer Hospital
Changchun, 132013
ChinaSite Not Available
the First Hospital of Jilin University
Changchun, 130021
ChinaSite Not Available
Changzhou First People's Hospital
Changzhou, 213003
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, 610041
ChinaSite Not Available
Third Affiliated Hospital of Third Military Medical University
ChongQing, 400042
ChinaSite Not Available
Second Affiliated Hospital of Third Military Medical University
Chongqing, 400030
ChinaSite Not Available
Guangdong General Hospital
Guangzhou, 510080
ChinaSite Not Available
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120
ChinaSite Not Available
Sun Yet-sen University Cancer Center
Guangzhou City, 510663
ChinaSite Not Available
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, 310003
ChinaSite Not Available
Sir Run Run Shaw Hospital
Hangzhou City, 310018
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin, 150081
ChinaSite Not Available
Jiangsu Cancer Hospital
Nanjing, 210009
ChinaSite Not Available
Jiangsu Cancer Hospital
Nanjing City, 211100
ChinaSite Not Available
The Affiliated Hospital of Medical College Qingdao University
Qingdao, 266003
ChinaSite Not Available
Shanghai chest hospital
Shanghai, 200030
ChinaSite Not Available
Zhongshan Hospital Fudan University
Shanghai, 200032
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai City, 200120
ChinaSite Not Available
Liaoning cancer Hospital & Institute
Shenyang, 110042
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, 300052
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin (天津), 300052
ChinaSite Not Available
The First Affiliated Hospital of Xian Jiao Tong University
Xi'an City, 710061
ChinaSite Not Available
empty
Xian,
ChinaSite Not Available
Zhejiang Cancer Hospital
Zhejiang, 310022
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, 450008
ChinaSite Not Available
Kyungpook National University Medical Center
Daegu, 41404
Korea, Republic ofSite Not Available
Chungnam National University Hospital
Daejeon, 35015
Korea, Republic ofSite Not Available
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofSite Not Available
Hospital Sultan Ismail; Oncology
Johor Bahru, 81100
MalaysiaSite Not Available
Hospital Kuala Lumpur; Jabatan Radioterapi dan Onkologi
Kuala Lumpur, 50586
MalaysiaSite Not Available
Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care
Sarawak, 93586
MalaysiaSite Not Available
National Cancer Centre; Medical Oncology
Singapore, 169610
SingaporeSite Not Available
Chulalongkorn Hospital; Medical Oncology
Bangkok, 10330
ThailandSite Not Available
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, 10700
ThailandSite Not Available
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, 10400
ThailandSite Not Available
CHIANG MAI UNI HOSPITAL; FACULTY OF MEDICINE; Medical Oncology unit
Chiang Mai, 50200
ThailandSite Not Available
Khon Kaen University
Khon Kaen, 40002
ThailandSite Not Available

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