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
Recruiting now · Phase 3
Conditions studied: Advanced or Metastatic Non-small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT07170995
- Run by
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- People needed
- 460
- Starts
- 2025-10-22
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2025-11-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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