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
SHR-8068，adebelizumab and platinum-based chemotherapytislelizumab, and platinum-based chemotherapy
SHR-8068，adebelizumab and platinum-based chemotherapy: SHR-8068，adebelizumab and platinum-based chemotherapy
tislelizumab, and platinum-based chemotherapy: tislelizumab, and platinum-based chemotherapy
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Voluntary participation and written informed consent.
2. 18-75 years old, no gender limitation.
3. 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.
4. Confirmed tumor PD-L1 status prior to randomization.
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1
6. With a life expectancy ≥ 3 months.
7. At least one measurable lesion according to RECIST v1.1.
Exclusion Criteria:
1. Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
2. Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
3. Previous or co-existing malignancies；
4. Have Active or prior documented autoimmune or inflammatory disorders;
5. Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
6. Have an active or past medical history of interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/pneumonitis.
Primary outcome measure(s)
Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR] — Approximately 32 months. PFS (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\]) by BICR was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression)
OS — Approximately 64 months. OS was defined as the time from the date of randomization until death due to any cause.
Trial sites (1)
Facility
City
Region
Status
Affiliated Cancer Hospital of Shandong First Medical University
Jinan
Shandong
Recruiting
More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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