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

Last updated: September 23, 2024
Sponsor: Sichuan University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Treatment

Adebrelimab

Chemotherapy

low dose radiotherapy

Clinical Study ID

NCT06610734
SKY
2024 Review (No. 1573)
  • Ages 18-75
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

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 forextensive SCLC prior to enrollment.

Exclusion

Exclusion Criteria:

  • Tissue classifications of mixed small cell lung cancer and non-small cell lungcancer;

  • Patients who have undergone major surgical procedures within 28 days prior to theinitial administration of the study drug, or those planning to undergo major surgeryduring the study period (as determined by the investigator);

  • Receipt of live attenuated vaccines within 28 days before the first dose or plannedfor 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 radiotherapyprior to systemic therapy;

  • Any previous T-cell co-stimulation or immune checkpoint therapies administered;

  • Documented history of allogeneic organ transplantation or allogeneic hematopoieticstem cell transplantation."

Study Design

Total Participants: 202
Treatment Group(s): 3
Primary Treatment: Adebrelimab
Phase: 3
Study Start date:
October 01, 2024
Estimated Completion Date:
December 31, 2028

Study 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.