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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

NCT06091943 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-08-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • BeiGene

    lead INDUSTRY

Principal Investigators

  • Study Director · BeiGene

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-16
Primary Completion
2025-07-31
Completion
2026-07-31
FDA Drug
Yes

Countries

  • China
  • Georgia
  • Moldova

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091943 on ClinicalTrials.gov