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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Affiliated Cancer Hospital of Shandong First Medical University
RECRUITING
Jinan
Contact Information
Primary
Weixia Li
weixia.li@hengrui.com
+86 021-61053363
Backup
Yang Wang
yang.wang.yw263@hengrui.com
+86 021-61053363
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2030-12
Participants
Target number of participants: 460
Treatments
Experimental: SHR-8068,adebelizumab and platinum-based chemotherapy
Active_comparator: tislelizumab, and platinum-based chemotherapy
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov

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