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A Phase Ⅱ Exploratory Clinical Study of Adebrelimab Combined With Chemotherapy and Concurrent Radiotherapy as First-Line Treatment for Extensive-Stage Oligometastatic Small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of adebelizumab combined with carboplatin/Cisplatin plus (+) etoposide and concurrent radiotherapy in the first-line treatment of patients with extensive stage oligometastatic small cell lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Signed inform consent form

• Age \>= 18 years and \<= 75 years

• Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system),the number of metastatic lesions ≤ 5, the number of metastatic organs ≤ 3, and no previous systemic chemotherapy, radiotherapy or immune checkpoint inhibitor treatment.

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Expected survival time ≥ 3 months

• Patients must submit a pre-treatment tumor tissue sample during the study.

• Adequate hematologic and end organ function

Locations
Other Locations
China
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Time Frame
Start Date: 2023-12-10
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 62
Treatments
Experimental: Treatment (Adebrelimab, chemotherapy, radiation therapy)
Participants will receive Adebrelimab intravenously in combination with carboplatin /Cisplatin and etoposide during the induction phase (2 Cycles ). Thereafter, participants will receive concurrent chemoradiotherapy(thoracic radiation therapy and SBRT for metastases,combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles).Then participants will receive Adebrelimab combination with carboplatin /Cisplatin and etoposide for 1-2 Cycles,followed by Adebrelimab maintenance until persistent radiographic PD, intolerable toxicity or withdrawal of consent during the maintenance phase.
Sponsors
Collaborators: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov

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