A Phase II Clinical Study of SHR-7787 Injection Combined With SHR-1316 Injection in Patients With LS-SCLC

August 28, 2026 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.

A Multicenter, Open-label, Phase Ⅱ Clinical Study of SHR-7787 Injection Combined With Adebrelimab in Patients With Limited Stage Small Cell Lung Cancer

This study is an open-label, multicenter, phase II clinical study designed to evaluate the preliminary efficacy, safety, and tolerability of SHR-7787 in combination with Adebrelimab in patients with limited-stage small cell lung cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250117
        • Cancer Hospital of Shandong First Medical University
        • Principal Investigator:
          • Jinming Yu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-7787 (Dose 1) + SHR-1316 group
Drug: SHR-7787 Injection
SHR-7787 injection.
Drug: SHR-1316
SHR-1316 (Adebrelimab) Injection.
Experimental: SHR-7787 (Dose 2) + SHR-1316 group
Drug: SHR-7787 Injection
SHR-7787 injection.
Drug: SHR-1316
SHR-1316 (Adebrelimab) Injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events (AEs)
Time Frame: Approximately 3 weeks
The dose expansion part of Phase 1
Approximately 3 weeks
Incidence and severity of serious adverse events (SAEs)
Time Frame: Approximately 3 weeks
The dose expansion part of Phase 1
Approximately 3 weeks
Progression-Free Survival (PFS)
Time Frame: Approximately 16 months
The dose expansion part of Phase 1
Approximately 16 months
Progression-Free Survival (PFS)
Time Frame: Approximately 16 months
The efficacy expansion part of Phase 2
Approximately 16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Approximately 16 months
The dose expansion part of Phase 1
Approximately 16 months
Objective Response Rate (ORR)
Time Frame: Approximately 16 months
The dose expansion part of Phase 1
Approximately 16 months
Duration of Response (DoR)
Time Frame: Approximately 16 months
The dose expansion part of Phase 1
Approximately 16 months
Anti-Drug Antibody (ADA) of SHR-7787
Time Frame: Approximately 16 months
The dose expansion part of Phase 1
Approximately 16 months
Disease Control Rate (DCR)
Time Frame: Approximately 16 months
The dose expansion part of Phase 1
Approximately 16 months
Disease Control Rate (DCR)
Time Frame: Approximately 16 months
The efficacy expansion part of Phase 2
Approximately 16 months
Overall Survival (OS)
Time Frame: Approximately 16 months
The efficacy expansion part of Phase 2
Approximately 16 months
Objective Response Rate (ORR)
Time Frame: Approximately 16 months
The efficacy expansion part of Phase 2
Approximately 16 months
Duration of Response (DoR)
Time Frame: Approximately 16 months
The efficacy expansion part of Phase 2
Approximately 16 months
Anti-Drug Antibody (ADA) of SHR-7787
Time Frame: Approximately 16 months
The efficacy expansion part of Phase 2
Approximately 16 months
Incidence and severity of adverse events (AEs)
Time Frame: Approximately 16 months
The efficacy expansion part of Phase 2
Approximately 16 months
Incidence and severity of serious adverse events (SAEs)
Time Frame: Approximately 16 months
The efficacy expansion part of Phase 2
Approximately 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

August 28, 2026

First Submitted That Met QC Criteria

August 28, 2026

First Posted (Actual)

September 2, 2026

Study Record Updates

Last Update Posted (Actual)

September 2, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-7787-201-LS-SCLC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe