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) (SKY)

NCT06610734 Phase 2 RECRUITING

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)

Details

Lead sponsor	Sichuan University
Phase	Phase 2
Status	RECRUITING
Enrolment	202
Start date	2024-12-23
Completion	2028-12

Conditions

• Small Cell Lung Cancer Extensive Stage

Interventions

• Adebrelimab
• Chemotherapy
• low dose radiotherapy

Primary outcomes

• overall survival — From date of randomization to the time when the subject died from any cause, up to approximately 36 months
  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).

Countries

China