Evaluating the Efficacy and Safety of Adebrelimab in Combination with Chemotherapy and LDRT As 1L Treatment for ES-SCLC

Phase 3

Not yet recruiting

• Conditions: Small Cell Lung Cancer Extensive Stage
• Interventions: Drug: Adebrelimab; Drug: Chemotherapy; Radiation: low dose radiotherapy

• Registration Number: NCT06610734
• Lead Sponsor: Sichuan University

Brief Summary

A multicenter, open-label, phase Ⅲ randomized controlled trial evaluating the efficacy and safety of adebrelimab in combination with chemotherapy and low-dose radiotherapy (LDRT) as first-line treatment for extensive-stage small cell lung cancer (SCLC)

Detailed Description

A multicenter, open-label, phase III randomized controlled trial evaluating the efficacy andsafety of adbelizumab in combination with chemotherapy and low-dose radiotherapy (LDRT) as a first-line treatment for extensive-stage small cell lung cancer (SCLC). At least 202 participants will be enrolled in this study.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-14
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Study Start: 2024-10
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• 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.

Exclusion Criteria

• 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."

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Adebrelimab	Adebrelimab combined with chemotherapy synchronous LDRT
Group A	Chemotherapy	Adebrelimab combined with chemotherapy synchronous LDRT
Group A	low dose radiotherapy	Adebrelimab combined with chemotherapy synchronous LDRT
Group B	Adebrelimab	Adebrelimab combined with chemotherapy
Group B	Chemotherapy	Adebrelimab combined with chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression free survival	Every 6 weeks from the first dose of study drug, and every 12 weeks after 48 weeks, up to approximately 24 months	Refers to the time from the start of randomization until tumor progression or death from any cause, whichever occurs first

Secondary Outcome Measures

Name	Time	Method
overall survival	From date of randomization to the time when the subject died from any cause, up to approximately 24 months	Refers to the time from the start of randomization until death from any cause.
Disease control rate	Every 6 weeks from the first dose of study drug, and every 12 weeks after 48 weeks, up to approximately 24 months	Proportion of all randomised subjects whose best overall response (BOR) was rated as complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1 criteria.
overall response rate	Every 6 weeks (±7 days) from the first dose of study drug, and every 12 weeks (±7 days) after 48 weeks, up to approximately 24 months	Refers to the proportion of patients who have achieved a pre-defined tumor volume reduction (CR/PR) and maintained the minimum time frame required by the accepted response evaluation criteria (such as solid tumor RECIST Version 1.1).
Duration of response	Every 6 weeks from the first dose of study drug, and every 12 weeks after 48 weeks, up to approximately 24 months	Defined as the period from the date the tumor remission was first recorded to the date the disease progression was first recorded or the date of death from any cause.
Post-progression survival	From date of progression to the time when the subject died from any cause, up to approximately 24 months	From date of progression to the time when the subject died from any cause
adverse events	Baseline up to approximately 36 months	The incidence and severity of adverse events, with severity determined according to the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0)
Serious adverse events	Baseline up to approximately 36 months	The incidence and severity of adverse events, with severity determined according to the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (CTCAEv5.0)