SHR-8068 with adebrelimab and chemotherapy versus tislelizumab with chemotherapy for first-line advanced or metastatic non-small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Weixia Li
• Email: weixia.li@hengrui.com
• Phone: +86 021-61053363

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.