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Not yet recruitingNCT07798947Updated Sep 2, 2026

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

A Phase 2 interventional study of SHR-7787 Injection and SHR-1316 in Limited-stage Small-cell Lung Cancer, sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Limited-stage Small-cell Lung Cancer
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    SHR-7787 (Dose 1) + SHR-1316 group

    Drug: SHR-7787 Injection · Drug: SHR-1316

  • Experimental
    SHR-7787 (Dose 2) + SHR-1316 group

    Drug: SHR-7787 Injection · Drug: SHR-1316

Interventions

  • DrugSHR-7787 Injection

    SHR-7787 injection.

  • DrugSHR-1316

    SHR-1316 (Adebrelimab) Injection.

05

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    The dose expansion part of Phase 1

    Time frame: Approximately 3 weeks

  2. Incidence and severity of serious adverse events (SAEs)

    The dose expansion part of Phase 1

    Time frame: Approximately 3 weeks

  3. Progression-Free Survival (PFS)

    The dose expansion part of Phase 1

    Time frame: Approximately 16 months

  4. Progression-Free Survival (PFS)

    The efficacy expansion part of Phase 2

    Time frame: Approximately 16 months

Secondary outcomes

  1. Overall Survival (OS)

    The dose expansion part of Phase 1

    Time frame: Approximately 16 months

  2. Objective Response Rate (ORR)

    The dose expansion part of Phase 1

    Time frame: Approximately 16 months

  3. Duration of Response (DoR)

    The dose expansion part of Phase 1

    Time frame: Approximately 16 months

  4. Anti-Drug Antibody (ADA) of SHR-7787

    The dose expansion part of Phase 1

    Time frame: Approximately 16 months

  5. Disease Control Rate (DCR)

    The dose expansion part of Phase 1

    Time frame: Approximately 16 months

  6. Disease Control Rate (DCR)

    The efficacy expansion part of Phase 2

    Time frame: Approximately 16 months

  7. Overall Survival (OS)

    The efficacy expansion part of Phase 2

    Time frame: Approximately 16 months

  8. Objective Response Rate (ORR)

    The efficacy expansion part of Phase 2

    Time frame: Approximately 16 months

  9. Duration of Response (DoR)

    The efficacy expansion part of Phase 2

    Time frame: Approximately 16 months

  10. Anti-Drug Antibody (ADA) of SHR-7787

    The efficacy expansion part of Phase 2

    Time frame: Approximately 16 months

  11. Incidence and severity of adverse events (AEs)

    The efficacy expansion part of Phase 2

    Time frame: Approximately 16 months

  12. Incidence and severity of serious adverse events (SAEs)

    The efficacy expansion part of Phase 2

    Time frame: Approximately 16 months

06

Study locations

1 site
  • Cancer Hospital of Shandong First Medical University
    Jinan, Shandong 250117, China
    • Jinming Yu · Contact · sdyujinming@126.com · +86-0531-67626073
    • Jinming Yu · Principal investigator
07

Registry details

Key details

Study ID
NCT07798947
Lead sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 2, 2026
Start date
Sep 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Xiaoxia Lu
Contact
xiaoxia.lu@hengrui.com
+86-0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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