Status:
RECRUITING
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
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Advanced or Metastatic Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 versu...
Eligibility Criteria
Inclusion
- Voluntary participation and written informed consent.
- 18-75 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
- 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.
Key Trial Info
Start Date :
October 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT07170995
Start Date
October 22 2025
End Date
December 1 2030
Last Update
November 18 2025
Active Locations (1)
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1
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117