RecruitingPhase 2NCT06610734

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)


Sponsor

Sichuan University

Enrollment

202 participants

Start Date

Dec 23, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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.\"

Interventions

RADIATIONlow dose radiotherapy

low dose radiotherapy

DRUGAdebrelimab

Adebrelimab combined with chemotherapy synchronous LDRT

DRUGChemotherapy

Chemotherapy


Locations(1)

West China Hospital of Sichuan University

Sichuan, China

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NCT06610734


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