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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • SHR-8068,adebelizumab and platinum-based chemotherapy
  • tislelizumab, and platinum-based chemotherapy

Treatment groups

460 Participants
are divided into 2 treatment groups