RecruitingPhase 3NCT07170995

Phase III Study of SHR-8068 Combined With Adebrelimab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in the Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer

A Randomized, Open-label, Controlled, Multicenter Phase III Study of SHR-8068 Combined With Adebrelimab and Platinum-based Chemotherapy Versus Tislelizumab Combined With Platinum-based Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Non-small Cell Lung Cancer

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

460 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced or Metastatic Non-small Cell Lung Cancer

Summary

This study is a randomized, open-label, controlled, multicenter Phase III clinical trial to evaluate the efficacy and safety of SHR-8068 combined with adebrelimab and platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

Voluntary participation and written informed consent.
years old, no gender limitation.
Newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic non-small cell lung cancer (NSCLC) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.
Confirmed tumor PD-L1 status prior to randomization.
Eastern Cooperative Oncology Group (ECOG) score: 0-1
With a life expectancy ≥ 3 months.
At least one measurable lesion according to RECIST v1.1.

Exclusion Criteria6

Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
Previous or co-existing malignancies；
Have Active or prior documented autoimmune or inflammatory disorders;
Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
Have an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.