NCT06091943

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-16
• Primary completion: 2025-07-31
• Completion: 2026-07-31
• First posted: 2023-10-23
• Last updated: 2025-08-12

Locations

15 sites across 3 countries: China, Georgia, Moldova

Regulatory

• FDA-regulated drug study