Clinical Trials in China / NCT07170995
Recruiting
Phase 3
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
NCT07170995 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced or Metastatic Non-small Cell Lung Cancer
Investigational drug(s) / intervention(s)
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
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 |
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Official registry record
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.
View NCT07170995 on ClinicalTrials.gov ↗ ← All trials in China