Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)

NCT06610734 | Recruiting Phase 2

• 2 other identifiers: SKY2024 Review (No. 1573)
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)

Conditions

Small Cell Lung Cancer Extensive Stage

Keywords

SCLC; Adebrelimab; LDRT

Outcome Measures

Primary Outcomes (1)

• overall survival

  Time from randomization to death from any cause. Unit of measure: median overall survival (months); hazard ratio (HR) and 95% confidence interval (CI); 12- and 24-month survival rates (%). Assessment schedule: survival status assessed every 3 months after the end of treatment until death or study cut-off (up to 36 months).

  From date of randomization to the time when the subject died from any cause, up to approximately 36 months

Secondary Outcomes (9)

• Progression free survival

  From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months.

• Time to second progression or death (PFS2)

  From date of randomization to the date of second documented progression or death from any cause, whichever occurs first, assessed up to 36 months

• Disease control rate

  From date of randomization until disease progression, death, or 24 months, whichever occurs first.

• Overall response rate (ORR)

  From date of randomization until disease progression, death, or 24 months, whichever occurs first

• Duration of response (DoR)

  From the date of first CR/PR to the date of documented progression or death from any cause, assessed up to 36 months

Other Outcomes (10)

• Correlation of PD-L1 expression with overall survival

  From baseline to death from any cause, assessed up to 36 months

• Correlation of PD-L1 expression with progression-free survival

  From date of randomization to the date of documented progression or death from any cause, whichever occurs first, assessed up to 36 months.

• Correlation of neutrophil count with overall survival

  From baseline to death from any cause, assessed up to 36 months

Study Arms (2)

Group A

EXPERIMENTAL

Adebrelimab combined with chemotherapy synchronous LDRT

Drug: Adebrelimab; Drug: Chemotherapy; Radiation: low dose radiotherapy

Group B

ACTIVE COMPARATOR

Adebrelimab combined with chemotherapy

Drug: Adebrelimab; Drug: Chemotherapy

Interventions

Adebrelimab DRUG

Adebrelimab combined with chemotherapy synchronous LDRT

Also known as: immunotherapy, Programmed death ligand 1 inhibitor

Group A; Group B

Chemotherapy DRUG

Chemotherapy

Group A; Group B

low dose radiotherapy RADIATION

low dose radiotherapy

Group A

Eligibility Criteria

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

You may qualify if:

• Participants aged 18 to 75 years, regardless of gender;
• ECOG Performance Status (PS) score of 0-1;
• Expected survival duration of no less than 8 weeks;
• Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system);
• Subjects must not have received systemic therapy or radical radiotherapy for extensive SCLC prior to enrollment.

You may not qualify if:

• Tissue classifications of mixed small cell lung cancer and non-small cell lung cancer;
• Patients who have undergone major surgical procedures within 28 days prior to the initial administration of the study drug, or those planning to undergo major surgery during the study period (as determined by the investigator);
• Receipt of live attenuated vaccines within 28 days before the first dose or planned for the duration of the study;
• Participation in another clinical trial within 28 days preceding initial dosing, involving any experimental agents;
• History of receiving chest radiotherapy or plans for intensive chest radiotherapy prior to systemic therapy;
• Any previous T-cell co-stimulation or immune checkpoint therapies administered;
• Documented history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\"

Sponsors & Collaborators

• Sichuan University: lead
• Shanghai Shengdi Pharmaceutical Co., Ltd: collaborator

Study Sites (1)

West China Hospital of Sichuan University

Sichuan, China

RECRUITING

MeSH Terms

Interventions

Immunotherapy; Immune Checkpoint Inhibitors; Drug Therapy; Radiotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• You Lu

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

You Lu

CONTACT

02885424619; radyoulu@hotmail.com

Zhuoran Yao, M.D.

CONTACT

yaozhuoran@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Cancer Ward

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: September 24, 2024
• Study Start: December 23, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After the study is completed.
• Access Criteria: Other Medical Professionals with permission from Principle Investigator

Locations

CN (1)