SHR-8068 with adebrelimab and chemotherapy versus tislelizumab with chemotherapy for first-line 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

This trial will test whether SHR-8068 plus adebrelimab with platinum chemotherapy works better than tislelizumab with platinum chemotherapy as first treatment for adults with newly diagnosed advanced or metastatic non-small cell lung cancer.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation, adebrelimab, tislelizumab, chemotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07170995 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label, controlled Phase III trial comparing SHR-8068 combined with adebrelimab plus platinum-based chemotherapy to tislelizumab plus platinum-based chemotherapy as first-line treatment for advanced or metastatic non-small cell lung cancer. Eligible participants are treatment-naive adults with histologically or cytologically confirmed disease, known tumor PD-L1 status, ECOG performance status 0-1, a life expectancy of at least three months, and at least one measurable lesion. Patients are randomized to one of the two combination arms and receive the assigned immunotherapy agents together with standard platinum chemotherapy while efficacy and safety are monitored over time. The trial is being conducted at multiple centers with a lead site at the Affiliated Cancer Hospital of Shandong First Medical University in Jinan, Shandong.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 years old with newly diagnosed, treatment‑naive locally advanced or metastatic NSCLC, ECOG 0–1, measurable disease by RECIST v1.1, and a known tumor PD‑L1 status.

Not a fit: Patients with untreated central nervous system metastases, active autoimmune or inflammatory disorders, active hepatitis B or C, immunodeficiency, uncontrolled effusions, prior or concurrent malignancies, or prior systemic therapy are unlikely to benefit and are excluded.

Why it matters

Potential benefit: If successful, this combination could provide better tumor control or longer survival than current PD-1/PD-L1 inhibitor plus chemotherapy regimens.

How similar studies have performed: PD‑1/PD‑L1 inhibitors combined with platinum chemotherapy have improved outcomes in multiple Phase III first‑line NSCLC trials, but the specific SHR‑8068 plus adebrelimab combination is novel and has limited Phase III data so far.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (Recruiting)

Study contacts

• Study coordinator: Weixia Li

Conditions Advanced or Metastatic Non-small Cell Lung Cancer