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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Advanced or Metastatic Non-small Cell Lung Cancer

Treatments: Drug: SHR-8068，adebelizumab and platinum-based chemotherapy; Drug: tislelizumab, and platinum-based chemotherapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT07170995

SHR-8068-302

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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460 participants in 2 patient groups

SHR-8068，adebelizumab and platinum-based chemotherapy

Experimental group

Treatment:

Drug: SHR-8068，adebelizumab and platinum-based chemotherapy

tislelizumab, and platinum-based chemotherapy

Active Comparator group

Treatment:

Drug: tislelizumab, and platinum-based chemotherapy