Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06091943
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Tislelizumab IV

Planned doses will be administered intravenously.

DRUG

Tislelizumab SC

Planned doses will be administered via subcutaneous injection.

DRUG

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