Trial Title:
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
NCT ID:
NCT05635708
Condition:
Non-small Cell Lung Cancer
Metastatic Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pemetrexed
Tislelizumab
Conditions: Keywords:
Non-small Cell Lung Cancer
NSCLC
programmed cell death protein-1
PD-L1 Low Tumors
PD-L1 Negative Tumors
Metastatic Non-Small Cell Lung Cancer
PD-L1 High Tumors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Administered by intravenous infusion
Arm group label:
Sub-study 1: Experimental Arm 1A
Arm group label:
Sub-study 1: Experimental Arm 2A
Arm group label:
Sub-study 1: Experimental Arm 3A
Arm group label:
Sub-study 1: Reference Arm Tislelizumab alone
Arm group label:
Sub-study 2: Experimental Arm 1B
Arm group label:
Sub-study 2: Experimental Arm 2B
Arm group label:
Sub-study 2: Experimental Arm 3B
Arm group label:
Sub-study 2: Reference Arm
Intervention type:
Drug
Intervention name:
BGB-A445
Description:
Administered by intravenous infusion
Arm group label:
Sub-study 1: Experimental Arm 1A
Arm group label:
Sub-study 2: Experimental Arm 1B
Intervention type:
Drug
Intervention name:
LBL-007
Description:
Administered by intravenous infusion
Arm group label:
Sub-study 1: Experimental Arm 2A
Arm group label:
Sub-study 2: Experimental Arm 2B
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Investigator's choice; administered by intravenous infusion
Arm group label:
Sub-study 2: Experimental Arm 1B
Arm group label:
Sub-study 2: Experimental Arm 2B
Arm group label:
Sub-study 2: Experimental Arm 3B
Arm group label:
Sub-study 2: Reference Arm
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Investigator's choice; administered by intravenous infusion
Arm group label:
Sub-study 2: Experimental Arm 1B
Arm group label:
Sub-study 2: Experimental Arm 2B
Arm group label:
Sub-study 2: Experimental Arm 3B
Arm group label:
Sub-study 2: Reference Arm
Intervention type:
Drug
Intervention name:
pemetrexed
Description:
Investigator's choice; administered by intravenous infusion
Arm group label:
Sub-study 2: Experimental Arm 1B
Arm group label:
Sub-study 2: Experimental Arm 2B
Arm group label:
Sub-study 2: Experimental Arm 3B
Arm group label:
Sub-study 2: Reference Arm
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Investigator's choice; administered by intravenous infusion
Arm group label:
Sub-study 2: Experimental Arm 1B
Arm group label:
Sub-study 2: Experimental Arm 2B
Arm group label:
Sub-study 2: Experimental Arm 3B
Arm group label:
Sub-study 2: Reference Arm
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
Investigator's choice; administered by intravenous infusion
Arm group label:
Sub-study 2: Experimental Arm 1B
Arm group label:
Sub-study 2: Experimental Arm 2B
Arm group label:
Sub-study 2: Experimental Arm 3B
Arm group label:
Sub-study 2: Reference Arm
Intervention type:
Drug
Intervention name:
BGB-15025
Description:
Administered Orally
Arm group label:
Sub-study 1: Experimental Arm 3A
Arm group label:
Sub-study 2: Experimental Arm 3B
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%).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. 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.
3. 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.
4. At least 1 measurable lesion as defined per RECIST v1.1.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion Criteria:
1. Has mixed small cell lung cancer.
2. Participants with known actionable mutations (including but not limited to EGFR,
ALK, BRAF, RET, and ROSI mutations) for which a targeted therapy is available per
local standard of care.
3. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any
other antibody or drug targeting T-cell costimulation or immune checkpoint pathways.
Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies
targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a
treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy
prior to radiologic recurrence of disease.
4. Has received any Chinese herbal medicine or Chinese patent medicines used to control
cancer ≤ 14 days before randomization/enrollment.
5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active
autoimmune diseases.
NOTE: Other protocol and sub-study protocol defined criteria may apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center Mskcc
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas Md Anderson Cancer Center
Address:
City:
Houston
Zip:
77030-4009
Country:
United States
Status:
Recruiting
Facility:
Name:
Blacktown Cancer and Haematology Centre
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Status:
Recruiting
Facility:
Name:
Chris Obrien Lifehouse
Address:
City:
Camperdown
Zip:
2050
Country:
Australia
Status:
Recruiting
Facility:
Name:
Northern Beaches Hospital
Address:
City:
Frenchs Forest
Zip:
2086
Country:
Australia
Status:
Recruiting
Facility:
Name:
Port Macquarie Base Hospital
Address:
City:
Port Macquarie
Zip:
2444
Country:
Australia
Status:
Recruiting
Facility:
Name:
One Clinical Research
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
St John of God Health Care
Address:
City:
Subiaco
Zip:
6008
Country:
Australia
Status:
Recruiting
Facility:
Name:
Hospital de Amor Barretos
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Hospital Do Cancer de Londrina
Address:
City:
Londrina
Zip:
86015-520
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Address:
City:
Porto Alegre
Zip:
90850-170
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
Address:
City:
Sao Jose do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
Address:
City:
Sao Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G1Z2
Country:
Canada
Status:
Recruiting
Facility:
Name:
The Second Hospital of Anhui Medical University
Address:
City:
Hefei
Zip:
230601
Country:
China
Status:
Recruiting
Facility:
Name:
Chinese Pla General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Hospital of Hebei University
Address:
City:
Baoding
Zip:
071000
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Facility:
Name:
Nantong Tumor Hospital Branch North
Address:
City:
Nantong
Zip:
226000
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Nanchang University Branch Xianghu
Address:
City:
Nanchang
Zip:
332000
Country:
China
Status:
Recruiting
Facility:
Name:
Jining No Peoples Hospital East Branch
Address:
City:
Jining
Zip:
272002
Country:
China
Status:
Recruiting
Facility:
Name:
Linyi Peoples Hospital
Address:
City:
Linyi
Zip:
276000
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Zhongshan Hospital of Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai East Hospital Branch Hospital
Address:
City:
Shanghai
Zip:
200123
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai Pulmonary Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Facility:
Name:
Shanxi Provincial Cancer Hospital
Address:
City:
Taiyuan
Zip:
030013
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Facility:
Name:
Taizhou Hospital of Zhejiang
Address:
City:
Taizhou
Zip:
317000
Country:
China
Status:
Recruiting
Facility:
Name:
Institut Curie
Address:
City:
Paris
Zip:
75005
Country:
France
Status:
Recruiting
Facility:
Name:
Chu Nantes Hopital Nord Laennec
Address:
City:
SaintHerblain
Zip:
44805
Country:
France
Status:
Recruiting
Facility:
Name:
Arensia Exploratory Medicine Llc
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs
Address:
City:
Roma
Zip:
00144
Country:
Italy
Status:
Recruiting
Facility:
Name:
Centro Ricerche Cliniche Di Verona
Address:
City:
Verona
Zip:
37134
Country:
Italy
Status:
Recruiting
Facility:
Name:
Chungbuk National University Hospital
Address:
City:
Cheongjusi
Zip:
28644
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
National Cancer Center
Address:
City:
Goyangsi
Zip:
10408
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnamsi
Zip:
13620
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea, St Vincents Hospital
Address:
City:
Suwonsi
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Pulau Pinang Hospital
Address:
City:
Georgetown
Zip:
10450
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Tengku Ampuan Afzan Hospital
Address:
City:
Kuantan
Zip:
25100
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Sarawak General Hospital
Address:
City:
Kuching
Zip:
93586
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
The Institute of Oncology, Arensia Exploratory Medicine
Address:
City:
Chisinau
Zip:
2025
Country:
Moldova, Republic of
Status:
Recruiting
Facility:
Name:
Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu
Address:
City:
Bucharest
Zip:
RO-022328
Country:
Romania
Status:
Recruiting
Facility:
Name:
Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu
Address:
City:
ClujNapoca
Zip:
400015
Country:
Romania
Status:
Recruiting
Facility:
Name:
National Cancer Centre Singapore
Address:
City:
Singapore
Zip:
168583
Country:
Singapore
Status:
Recruiting
Facility:
Name:
Hospital Universitario Vall Dhebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen Del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Songklanagarind Hospital (Prince of Songkhla University)
Address:
City:
Hat Yai
Zip:
90110
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Srinagarind Hospital (Khon Kaen University)
Address:
City:
Muang
Zip:
40002
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
Address:
City:
Muang
Zip:
50200
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
Address:
City:
Ongkharak
Zip:
26120
Country:
Thailand
Status:
Recruiting
Start date:
March 7, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05635708
