Phase
Condition
Non-small Cell Lung Cancer
Treatment
Tislelizumab
LBL-007
Nab paclitaxel
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC),including nonsquamous or squamous subtypes, that is either locally advanced orrecurrent and not eligible for curative surgery and/or definitive chemoradiotherapy,or metastatic NSCLC.
No prior systemic therapy administered as the primary treatment for metastaticNSCLC. Prior adjuvant or neoadjuvant chemotherapy, definitive chemoradiation, oradjuvant radiotherapy for locally advanced disease is permitted, provided the lastdose of chemotherapy and/or radiotherapy occurred at least 6 months prior torandomization/enrollment.
Tumor programmed death-ligand 1 (PD-L1) expression must be evaluable, as determinedby a local or central laboratory using archival tumor tissue or a fresh biopsy.Participants with unknown PD-L1 expression are not eligible.
At least one measurable lesion, as defined by Response Evaluation Criteria in SolidTumors (RECIST) version 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion
Key Exclusion Criteria:
Diagnosis of mixed small cell lung cancer.
Known genomic alterations for which effective targeted therapies are availableaccording to local standard of care, including but not limited to:
Epidermal growth factor receptor (EGFR) mutations
Anaplastic lymphoma kinase (ALK) rearrangements
B-Raf proto-oncogene (BRAF) mutations
Rearranged during transfection (RET) fusions
c-ros oncogene 1 (ROS1) rearrangements
Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergolocal testing. Those found to have EGFR-sensitizing mutations will be excluded.
Prior treatment with immune-based therapies that target immune checkpoint pathways,including:
PD-1 (programmed cell death protein 1) inhibitors
PD-L1 (programmed death-ligand 1) inhibitors
PD-L2 (programmed death-ligand 2) inhibitors
TIGIT (T cell immunoreceptor with Ig and ITIM domains) inhibitors
LAG-3 (lymphocyte activation gene 3) inhibitors
Participants previously treated with these agents in a neoadjuvant, adjuvant, orconsolidation setting may be eligible if a treatment-free interval of at least 6months has elapsed since the last dose and radiologic evidence of recurrence ispresent.
Use of Chinese herbal medicines or Chinese patent medicines intended for cancercontrol within 14 days prior to randomization/enrollment.
Presence of active leptomeningeal disease, untreated or uncontrolled brainmetastases, or active autoimmune disease.
Note: Additional protocol-defined and sub-study-specific criteria may apply.
Study Design
Connect with a study center
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales 2148
AustraliaSite Not Available
Chris Obrien Lifehouse
Camperdown, New South Wales 2050
AustraliaSite Not Available
Northern Beaches Hospital
Frenchs Forest, New South Wales 2086
AustraliaSite Not Available
Port Macquarie Base Hospital
Port Macquarie, New South Wales 2444
AustraliaSite Not Available
Port Macquarie Base Hospital
Port Macquarie,, New South Wales 2444
AustraliaSite Not Available
One Clinical Research
Nedlands, Western Australia 6009
AustraliaSite Not Available
St John of God Health Care
Subiaco, Western Australia 6008
AustraliaSite Not Available
Hospital de Amor Barretos
Barretos, 14784-400
BrazilSite Not Available
Hospital Do Cancer de Londrina
Londrina, 86015-520
BrazilSite Not Available
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270
BrazilSite Not Available
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Sao Jose Do Rio Preto, 15090-000
BrazilSite Not Available
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
Sao Paulo, 01246-000
BrazilSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
The Second Hospital of Anhui Medical University
Hefei, Anhui 230601
ChinaSite Not Available
Chinese Pla General Hospital
Beijing, Beijing 100853
ChinaActive - Recruiting
The Fifth Medical Center of Chinese Pla General Hospital
Beijing, Beijing 100071
ChinaSite Not Available
Fujian Cancer Hospital
Fuzhou, Fujian 350014
ChinaSite Not Available
Affiliated Hospital of Hebei University
Baoding, Hebei 071000
ChinaSite Not Available
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang 150000
ChinaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaSite Not Available
Hubei Cancer Hospital
Wuhan, Hubei 430079
ChinaSite Not Available
Nantong Tumor Hospital Branch North
Nantong, Jiangsu 226000
ChinaSite Not Available
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi 332000
ChinaSite Not Available
Jining No Peoples Hospital
Jining, Shandong 272000
ChinaActive - Recruiting
Jining No Peoples Hospital East Branch
Jining, Shandong 272002
ChinaSite Not Available
Linyi Peoples Hospital
Linyi, Shandong 276000
ChinaSite Not Available
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai 200032
ChinaSite Not Available
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai 200123
ChinaSite Not Available
Shanghai Pulmonary Hospital
Shanghai, Shanghai 200433
ChinaSite Not Available
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi 030013
ChinaSite Not Available
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300060
ChinaSite Not Available
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang 317000
ChinaSite Not Available
Institut Curie
Paris, 75005
FranceSite Not Available
Chu Nantes Hopital Nord Laennec
SaintHerblain, 44805
FranceSite Not Available
Arensia Exploratory Medicine Llc
Tbilisi, 0112
GeorgiaSite Not Available
Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs
Roma, 00144
ItalySite Not Available
Centro Ricerche Cliniche Di Verona
Verona, 37126
ItalySite Not Available
Chungbuk National University Hospital
Cheongjusi, Chungcheongbukdo 28644
Korea, Republic ofSite Not Available
Chungbuk National University Hospital
SeowonGu CheongjuSi, Chungcheongbukdo 28644
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
BundangGu SeongnamSi, Gyeonggi-do 13620
Korea, Republic ofSite Not Available
National Cancer Center
Goyangsi, Gyeonggi-do 10408
Korea, Republic ofActive - Recruiting
National Cancer Center (Korea)
Goyangsi, Gyeonggi-do 10408
Korea, Republic ofSite Not Available
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do 10408
Korea, Republic ofSite Not Available
The Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, Gyeonggi-do 16247
Korea, Republic ofSite Not Available
Seoul National University Bundang Hospital
Seongnamsi, Gyeonggi-do 13620
Korea, Republic ofSite Not Available
The Catholic University of Korea, St Vincents Hospital
Suwonsi, Gyeonggi-do 16247
Korea, Republic ofSite Not Available
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi 06351
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi 03722
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, Seoul Teugbyeolsi 06351
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofSite Not Available
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi 05505
Korea, Republic ofSite Not Available
Pulau Pinang Hospital
Georgetown, 10450
MalaysiaSite Not Available
Sultan Ismail Hospital
Johor Bahru, 81100
MalaysiaSite Not Available
Tengku Ampuan Afzan Hospital
Kuantan, 25100
MalaysiaSite Not Available
Sarawak General Hospital
Kuching, 93586
MalaysiaSite Not Available
Beacon Hospital
Petaling Jaya, 46050
MalaysiaSite Not Available
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, 2025
Moldova, Republic ofSite Not Available
Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu
Bucharest, RO-022328
RomaniaSite Not Available
Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu
Bucureti, 022328
RomaniaSite Not Available
Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu
ClujNapoca, 400015
RomaniaSite Not Available
Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricuta
ClujNapoca, 400015
RomaniaSite Not Available
National Cancer Centre Singapore
Singapore, 168583
SingaporeSite Not Available
Hospital Universitario Vall Dhebron
Barcelona, 08035
SpainSite Not Available
Hospital Universitario de Octubre
Madrid, 28041
SpainSite Not Available
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainSite Not Available
Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai, 90110
ThailandSite Not Available
Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
Muang, 50200
ThailandSite Not Available
Srinagarind Hospital (Khon Kaen University)
Muang, 40002
ThailandSite Not Available
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
Ongkharak, 26120
ThailandSite Not Available
California Cancer Associates For Research and Excellence, Ccare Encinitas
Encinitas, California 92024
United StatesSite Not Available
Valkyrie Clinical Trials
Los Angeles, California 90067-2011
United StatesSite Not Available
Hoag Memorial Presbyterian
Newport, California 92663
United StatesSite Not Available
Hoag Memorial Presbyterian
Newport Beach, California 92663-4162
United StatesSite Not Available
California Cancer Associates For Research and Excellence, Inc
San Marcos, California 92069
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center Basking Ridge
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Msk Basking Ridge
Basking Ridge, New Jersey 07920
United StatesSite Not Available
Msk Monmouth
Middletown, New Jersey 07748
United StatesSite Not Available
Msk Bergen
Montvale, New Jersey 07645
United StatesSite Not Available
Msk Commack
Commack, New York 11725
United StatesSite Not Available
Msk Westchester
Harrison, New York 10604
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York 10065-6800
United StatesSite Not Available
Msk Nassau
Uniondale, New York 11553
United StatesSite Not Available
Oncology and Hematology Care Clinic Westside
Portland, Oregon 97225-9722
United StatesSite Not Available
Providence Oncology and Hematology Care - Westside
Portland, Oregon 97225-9722
United StatesActive - Recruiting
Providence Portland Medical Center
Portland, Oregon 97213-2933
United StatesSite Not Available
The University of Texas Md Anderson Cancer Center
Houston, Texas 77030-4009
United StatesSite Not Available
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