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

NCT07798947 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-7787-201-LS-SCLC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Limited-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of adverse events (AEs)

  The dose expansion part of Phase 1

  Approximately 3 weeks

• Incidence and severity of serious adverse events (SAEs)

  The dose expansion part of Phase 1

  Approximately 3 weeks

• Progression-Free Survival (PFS)

  The dose expansion part of Phase 1

  Approximately 16 months

• Progression-Free Survival (PFS)

  The efficacy expansion part of Phase 2

  Approximately 16 months

Secondary Outcomes (12)

• Overall Survival (OS)

  Approximately 16 months

• Objective Response Rate (ORR)

  Approximately 16 months

• Duration of Response (DoR)

  Approximately 16 months

• Anti-Drug Antibody (ADA) of SHR-7787

  Approximately 16 months

• Disease Control Rate (DCR)

  Approximately 16 months

Study Arms (2)

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

EXPERIMENTAL

Drug: SHR-7787 Injection; Drug: SHR-1316

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

EXPERIMENTAL

Drug: SHR-7787 Injection; Drug: SHR-1316

Interventions

SHR-7787 Injection DRUG

SHR-7787 injection.

SHR-7787 (Dose 1) + SHR-1316 group; SHR-7787 (Dose 2) + SHR-1316 group

SHR-1316 DRUG

SHR-1316 (Adebrelimab) Injection.

SHR-7787 (Dose 1) + SHR-1316 group; SHR-7787 (Dose 2) + SHR-1316 group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form (ICF) in writing.
• Aged 18 to 75 years (inclusive), of any gender.
• 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.
• ECOG performance status score of 0 or 1.
• Estimated survival time of more than 3 months.
• Have adequate bone marrow and organ function.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xiaoxia Lu

CONTACT

+86-0518-82342973; xiaoxia.lu@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-7787 combined with SHR-1316.

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

CN (1)