A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
- Trial number:
- NCT05635708
- Trial phase:
- 2
- Study type:
- Any
- Overall status:
- Recruiting
Study start date
March, 2023
Scientific title
Master Protocol: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
Summary
The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (< 50%).
Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment. Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study. At least 1 measurable lesion as defined per RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Masking:
None (Open Label),
Conditions
Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
Other study ID numbers
BGB-LC-201; CTR20230892
Choose trial site (74)
National Cancer Centre Singapore
Valkyrie Clinical Trials, Inc.
2080 Century Park E Suite 803, Los Angeles, CA 90067, USA
Northern Beaches Hospital
105 Frenchs Forest Rd W, Frenchs Forest NSW 2086, Australia
Port Macquarie Base Hospital
Wrights Rd, Port Macquarie NSW 2444, Australia
Shanghai Pulmonary Hospital
China, Shang Hai Shi, Yang Pu Qu, 政民路507号 邮政编码: 200437
Taizhou Hospital of Zhejiang Province
Zhejiang, China
Valkyrie Clinical Trials
2080 Century Park E Suite 803, Los Angeles, CA 90067, USA
Blacktown Cancer and Haematology Centre
Blacktown NSW 2148, Australia
Port Macquarie Base Hospital
Wrights Rd, Port Macquarie NSW 2444, Australia
One Clinical Research
85 Monash Ave, Nedlands WA 6009, Australia
The Second Hospital of Anhui Medical University
678 Fu Rong Lu, Shu Shan Qu, He Fei Shi, An Hui Sheng, China, 230601
Fujian Cancer Hospital
Fuzhou, China, 350014
Henan Cancer Hospital
China, Zheng Zhou Shi, Jin Shui Qu, 北127127号CN 河南省 郑州市 金水区 东明路 邮政编码: 450003
Hubei Cancer Hospital
Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
China, Jiang Xi Sheng, Nan Chang Shi, Nan Chang Xian, 桃花东路HVQ8+V73 邮政编码: 330209
Jining No Peoples Hospital
Ji Ning Bei Hu Tong Li Jiao, Ren Cheng Qu, Ji Ning Shi, Shan Dong Sheng, China, 272507
Tianjin Medical University Cancer Institute and Hospital
35JM+2JF, Bin Shui Dao, He Xi Qu, Tian Jin Shi, China, 300060
Taizhou Hospital of Zhejiang
China, Zhe Jiang Sheng, Tai Zhou Shi, Lin Hai Shi, 紫阳古街西门街150 邮政编码: 317000
National Cancer Centre Singapore
30 Hospital Blvd, Singapore 168583
Memorial Sloan Kettering Cancer Center Mskcc
1275 York Ave # H-510, New York, NY 10065, USA
Chris Obrien Lifehouse
119-143 Missenden Rd, Camperdown NSW 2050, Australia
St John of God Health Care
556 Wellington St, Perth WA 6000, Australia
Affiliated Hospital of Hebei University
China, He Bei Sheng, Bao Ding Shi, 南市区裕华东路212号 邮政编码: 071051
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Hubei Cancer Hospital
16 Zhuo Dao Quan Nan Lu, Hong Shan Qu, Wu Han Shi, Hu Bei Sheng, China, 430079
Linyi Peoples Hospital
China, Shan Dong Sheng, Lin Yi Shi, Lan Shan Qu, Yi Zhou Lu, 解放路东段27号 邮政编码: 276000
Chungbuk National University Hospital
776 1sunhwan-ro, Seowon-gu, Cheongju, Chungcheongbuk-do, South Korea
National Cancer Center
323 Ilsan-ro, Goyang-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
82 Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, South Korea
Samsung Medical Center
81 Irwon-ro, Gangnam-gu, Seoul, South Korea
The Institute of Oncology, Arensia Exploratory Medicine
Chişinău, Moldova
Srinagarind Hospital (Khon Kaen University)
123 หมู่ที่ 16 Tambon Nai Mueang, Amphoe Mueang Khon Kaen, Chang Wat Khon Kaen 40002, Thailand
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
62 Tambon Ongkharak, Amphoe Ongkharak, Chang Wat Nakhon Nayok 26120, Thailand
California Cancer Associates For Research and Excellence, Ccare Encinitas
326 Santa Fe Dr Ste 105, Encinitas, CA 92024, USA
California Cancer Associates For Research and Excellence, Inc
San Marcos, CA 92069, USA
Massachusetts General Hospital
55 Fruit St, Boston, MA 02114, USA
Dana Farber Cancer Institute
450 Brookline Ave, Boston, MA 02215, USA
Msk Basking Ridge
136 Mountainview Blvd, Basking Ridge, NJ 07920, USA
Msk Monmouth
480 Red Hill Rd, Middletown Township, NJ 07748, USA
Msk Bergen
225 Summit Ave, Montvale, NJ 07645, USA
Msk Commack
650 Commack Rd, Commack, NY 11725, USA
Msk Westchester
500 Westchester Ave, West Harrison, NY 10604, USA
Msk Nassau
1101 Hempstead Tpke, Uniondale, NY 11553, USA
Providence Portland Medical Center
4805 NE Glisan St, Portland, OR 97213, USA
Oncology and Hematology Care Clinic Westside
Portland, OR, USA
The University of Texas Md Anderson Cancer Center
Houston, TX, USA
Hospital de Amor Barretos
R. Antenor Duarte Viléla, 1331 - Dr. Paulo Prata, Barretos - SP, 14784-400, Brazil
Hospital Do Cancer de Londrina
Rua Lucilla Ballalai, 212 - Jardim Petrópolis, Londrina - PR, 86015-520, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
R. Costa, 30 - Menino Deus, Porto Alegre - RS, 90110-270, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Av. Brg. Faria Lima, 5544 - Vila Sao Jose, São José do Rio Preto - SP, 15090-000, Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
Av. Dr. Arnaldo, 251 - Cerqueira César, São Paulo - SP, 01246-000, Brazil
Cross Cancer Institute
11560 University Ave, Edmonton, AB T6G 1Z2, Canada
Nantong Tumor Hospital Branch North
68 Gong Nong Lu, Chong Chuan Qu, Nan Tong Shi, Jiang Su Sheng, China, 226007
The First Affiliated Hospital of Soochow University
296 Shi Zi Jie, Cang Lang Qu, Su Zhou Shi, Jiang Su Sheng, China, 215005
Affiliated Zhongshan Hospital of Fudan University
180 Feng Lin Lu, Xu Hui Qu, Shang Hai Shi, China, 200031
Shanxi Provincial Cancer Hospital
Taiyuan, China, 030013
Arensia Exploratory Medicine Llc
13 Tevdore Mghvdeli St, T'bilisi, Georgia
Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs
Via Fermo Ognibene, 23, 00144 Roma RM, Italy
Centro Ricerche Cliniche Di Verona
Piazzale L.A. Scuro, 10, 37134 Verona VR, Italy
The Catholic University of Korea, St Vincents Hospital
93 Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do, South Korea
Severance Hospital Yonsei University Health System
50-1 Yonsei-ro, Seodaemun-gu, Seoul, South Korea
Asan Medical Center
88 Olympic-ro 43-gil, Songpa-gu, Seoul, South Korea
Pulau Pinang Hospital
Jalan Residensi, 10990 George Town, Pulau Pinang, Malaysia
Sultan Ismail Hospital
Jalan Mutiara Emas Utama, Taman Mount Austin, 81100 Johor Bahru, Johor, Malaysia
Tengku Ampuan Afzan Hospital
Jalan Tanah Putih, 25100 Kuantan, Pahang, Malaysia
Sarawak General Hospital
Jalan Hospital, 93586 Kuching, Sarawak, Malaysia
Beacon Hospital
1 Jalan 215, Off, Jalan Templer, Seksyen 51, 46050 Petaling Jaya, Selangor, Malaysia
Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu
Cluj-Napoca, Romania
Hospital Universitario Vall Dhebron
Pg. de la Vall d'Hebron, 119, Horta-Guinardó, 08035 Barcelona, Spain
Hospital Universitario de Octubre
Av. de Córdoba, s/n, Usera, 28041 Madrid, Spain
Hospital Universitario Virgen Del Rocio
Av. Manuel Siurot, S/n, 41013 Sevilla, Spain
Songklanagarind Hospital (Prince of Songkhla University)
Karnjanavanit Soi 15 Rd, Tambon Kho Hong, Amphoe Hat Yai, Chang Wat Songkhla 90110, Thailand
Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
110 Intrawarorot Road Soi 2, Tambon Si Phum, Amphoe Mueang Chiang Mai, Chang Wat Chiang Mai 50200, Thailand
Chinese Pla General Hospital
Beijing, China