Clinical trial · Interventional
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-8068,adebelizumab and platinum-based chemotherapy | Drug | — | UNRESOLVED |
| tislelizumab, and platinum-based chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-8068,adebelizumab and platinum-based chemotherapy
- interventionNames
- Drug: SHR-8068,adebelizumab and platinum-based chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- tislelizumab, and platinum-based chemotherapy
- interventionNames
- Drug: tislelizumab, and platinum-based chemotherapy
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR]
- timeFrame
- Approximately 32 months.
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available