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

Sichuan University

Status and phase: Not yet enrolling; Phase 3

Conditions: Small Cell Lung Cancer Extensive Stage

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06610734

SKY

2024 Review (No. 1573) (Other Identifier)

Details and patient eligibility

About

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)

Full 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.

Enrollment: 202 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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."

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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202 participants in 2 patient groups

Group A

Experimental group

Description:

Adebrelimab combined with chemotherapy synchronous LDRT

Treatment:

Drug: Chemotherapy

Radiation: low dose radiotherapy

Drug: Adebrelimab

Group B

Active Comparator group

Description:

Adebrelimab combined with chemotherapy

Treatment:

Drug: Chemotherapy

Drug: Adebrelimab