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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-8068，adebelizumab and platinum-based chemotherapy, tislelizumab, and platinum-based chemotherapy.
- Who it may be relevant to
- Registry conditions: Advanced or Metastatic Non-small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug SHR-8068，adebelizumab and platinum-based chemotherapy
SHR-8068，adebelizumab and platinum-based chemotherapy - Drug tislelizumab, and platinum-based chemotherapy
tislelizumab, and platinum-based chemotherapy
Primary outcome measures
- Progression-Free Survival (PFS) by Blinded Independent Central Review [BICR] [Time frame: Approximately 32 months.]
- OS [Time frame: Approximately 64 months.]
Secondary outcome measures (5)
- PFS by the investigator [Time frame: Approximately 32 months.]
- Objective Response Rate (ORR) [Time frame: Approximately 32 months.]
- Duration of Response (DoR) [Time frame: Approximately 32 month]
- Incidence and Severity of Adverse Events (AEs) [Time frame: Approximately 64 months.]
- Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ C30-Lung Cancer Module 13 (QLQ-LC13) [Time frame: Approximately 64 months.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Affiliated Cancer Hospital of Shandong First Medical University — Jinan
Identifiers
NCT: NCT07170995 · SHR-8068-302