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)
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- overall survival
Study Overview
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)
Detailed Description
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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."
Arms & Interventions
Group A
Adebrelimab combined with chemotherapy synchronous LDRT
Intervention: low dose radiotherapy (Radiation)
Group B
Adebrelimab combined with chemotherapy
Intervention: Adebrelimab (Drug)
Group B
Adebrelimab combined with chemotherapy
Intervention: Chemotherapy (Drug)
Group A
Adebrelimab combined with chemotherapy synchronous LDRT
Intervention: Adebrelimab (Drug)
Group A
Adebrelimab combined with chemotherapy synchronous LDRT
Intervention: Chemotherapy (Drug)
Outcomes
Primary Outcomes
overall survival
Time Frame: 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).
Secondary Outcomes
- 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)
- Depth of Response(From date of randomization until disease progression, death, or 24 months, whichever occurs first.)
- Post-progression survival (PPS)(From the date of documented progression to the date of death from any cause, assessed up to 36 months after progression.)
- Incidence and severity of adverse events (AEs)(Collect and assess safety-related test results and adverse events (AEs) for both the experimental group and the control group during the first-line and second-line treatment phases (to 90 days after the last dose of drug).)
- Incidence of serious adverse events (SAEs)(Collect and assess safety-related test results and adverse events (AEs) for both the experimental group and the control group during the first-line and second-line treatment phases(before 2nd PD and 3 month afterwords).)
Investigators
You Lu
Chief of Thoracic Cancer Ward
Sichuan University