Status:
NOT_YET_RECRUITING
Evaluating the Efficacy and Safety of Adebrelimab in Combination with Chemotherapy and LDRT As 1L Treatment for ES-SCLC
Lead Sponsor:
Sichuan University
Collaborating Sponsors:
Shanghai Shengdi Pharmaceutical Co., Ltd
Conditions:
Small Cell Lung Cancer Extensive Stage
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 treatme...
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 trea...
Eligibility Criteria
Inclusion
- 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
- 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.\"
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT06610734
Start Date
October 1 2024
End Date
December 1 2028
Last Update
September 24 2024
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