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Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor: BeiGene
Summary
This is an open-label, multicenter, Phase 1 clinical study to evaluate the bioavailability of tislelizumab subcutaneous (SC) injection in the first-line treatment of participants with advanced or metastatic non-small cell lung cancer (NSCLC). This clinical study will be divided into 2 parts: dose/injection site exploration (Part 1) and dose expansion (Part 2).
Official title: Phase 1 Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in the First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
62
Start Date
2023-11-16
Completion Date
2026-07-31
Last Updated
2025-08-12
Healthy Volunteers
No
Conditions
Interventions
Tislelizumab IV
Planned doses will be administered intravenously.
Tislelizumab SC
Planned doses will be administered via subcutaneous injection.
Histology-Based Chemotherapy Doublet
Chemotherapy Doublet 1: Cisplatin/carboplatin + pemetrexed. Chemotherapy Doublet 2: Carboplatin + paclitaxel/nab-paclitaxel. Choice of histology-based induction chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.
Locations (15)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
Jining No Peoples Hospital East Branch
Jining, Shandong, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Deyangs People Hospital
Deyang, Sichuan, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Arensia Exploratory Medicine Llc
Tbilisi, Georgia
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, Moldova