Shrinkage-free combo in LS-SCLC: SHR-7787 plus SHR-1316

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 an open-label, multicenter phase II study to assess the preliminary efficacy and safety of SHR-7787 given with SHR-1316 in patients with unresectable limited-stage small cell lung cancer who have not progressed after standard platinum-based therapy. Eligible participants are adults 18-75 with good performance status and adequate organ function. The study will monitor response rates, safety, and tolerability in a real-world clinical setting to determine whether this combination warrants further investigation. Enrollment is conducted at the Cancer Hospital of Shandong First Medical University in Jinan, with Shanghai Hengrui Pharmaceutical Co., Ltd as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form (ICF) in writing.
2. Aged 18 to 75 years (inclusive), of any gender.
3. Histologically or cytologically confirmed unresectable limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemotherapy and radiation therapy.
4. ECOG performance status score of 0 or 1.
5. Estimated survival time of more than 3 months.
6. Have adequate bone marrow and organ function.
7. Female trial participants of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug, and avoid donating eggs.

Exclusion Criteria:

1. Combined small cell lung cancer or any transformed small cell lung cancer.
2. History of other malignancies within 5 years prior to the first dose of the study drug.
3. Severe cardiovascular or cerebrovascular diseases.
4. Bleeding symptoms of significant clinical relevance within 3 months prior to the first dose of the study drug.
5. Malignant pleural effusion or malignant pericardial effusion.
6. Severe infection within 4 weeks prior to the initiation of study treatment.
7. Active tuberculosis infection within 1 year prior to enrollment, identified by medical history or imaging examination.
8. History of immunodeficiency.
9. Active, known, or suspected autoimmune disease, or a history of autoimmune disease.
10. Prior treatment with immune checkpoint inhibitors (ICIs).
11. Undergone major organ surgery within 4 weeks prior to the first dose of the study drug.
12. Any other factors that, in the judgment of the investigator, may affect the study results or force premature termination of the study.

Where it's running

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

Study contacts

• Study coordinator: Xiaoxia Lu
• Email: xiaoxia.lu@hengrui.com
• Phone: +86-0518-82342973

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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.