This is a single-arm, open-label, single-center phase II trial that will enroll 30 patients with limited-stage small-cell lung cancer to evaluate the safety and efficacy of adebrelimab combined with chemoradiotherapy followed by adebrelimab maintenance.
This investigator-initiated trial will be conducted in the Department of Radiation Oncology, Peking University Cancer Hospital. Thirty patients with limited-stage small-cell lung cancer (LS-SCLC) will be enrolled in this pilot study to explore whether the addition of adebrelimab to chemoradiotherapy can improve outcomes for this population. Eligible participants will receive adebrelimab combined with chemoradiotherapy(etoposide plus platinum). Patients who achieve complete or partial response will undergo prophylactic cranial irradiation (PCI) within 1-30 days after completion of chemoradiotherapy, followed by adebrelimab monotherapy (1200 mg intravenously every 3 weeks) as consolidation and maintenance for up to 24 months in the absence of progression or unacceptable toxicity. Treatment will be discontinued if the patient develops progressive disease, experiences unacceptable drug-related toxicity, withdraws consent, or meets any other pre-specified withdrawal criterion. Both efficacy (objective response rate, progression-free survival, overall survival) and safety (adverse events graded by CTCAE v5.0) endpoints will be assessed throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Adebrelimab combined with chemotherapy and concurrent radiotherapy, followed by maintenance therapy with Adebrelimab until disease progression or intolerable toxicity, for up to 2 years.
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, China
PFS
From subject enrollment to the first recorded disease progression or death from any cause, whichever occurs first
Time frame: through study completion, an average of 3 years
ORR
The proportion of subjects achieving complete response (CR) or partial response (PR) as their best overall response following treatment initiation, relative to the total number of subjects.
Time frame: through study completion, an average of 3 years
OS
Time from subject enrollment to death from any cause.
Time frame: through study completion, an average of 3 years
DCR
The proportion of subjects achieving complete response (CR), partial response (PR), or stable disease (SD) as their best overall response following treatment initiation, relative to the total number of subjects.
Time frame: through study completion, an average of 3 years
Adverse Events
AEs that occurred from the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment
Time frame: From the first dose of durvalumab to 90 days after the last dose of durvalumab or start of subsequent anticancer treatment
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