This study aims to evaluate the efficacy and safety of adebrelimab consolidation therapy after progression-free response of concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer. This study plans to enroll patients with untreated limited-stage small cell lung cancer who meet the inclusion criteria. The eligible patients will be randomly divided 1:1 into two groups to receive treatment regimens for residual lymph nodes and involved irradiated areas. That is, carboplatin AUC 5, D1 + etoposide 100 mg/m…\^2 on days 1, 2, and 3 + thoracic radiotherapy (residual lymph nodes or involved irradiated areas), with each 3-week cycle.After 4 cycles of concurrent chemoradiotherapy, the non-progressing subjects will continue to receive adebrelimab (1200 mg, IV, Q3W) maintenance therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Carboplatin AUC 5 d1 + Etoposide 100 mg/m² d1-3 + thoracic involved-field radiotherapy (IFRT), q3w × 4 cycles. Post-concurrent CCRT, non-PD subjects receive maintenance adebrelimab 1200 mg IV q3w.
Carboplatin/etoposide + thoracic residual-field RT, followed by maintenance adebrelimab in non-PD patients
Henan Cancer Hospital
Zhengzhou, Henan, China
PFS
progression-free survival: Time from the date of initiating concurrent chemoradiotherapy at enrollment to the first occurrence of objective tumor progression after starting maintenance therapy or all-cause death, whichever comes first.
Time frame: From date of the first treatment to the first documented disease progression, assessed up to 18 months
L-PFS
local progression-free survival: Time from start of concurrent CCRT to first local progression post-maintenance or all-cause death, whichever occurs first
Time frame: From date of the first treatment to the first documented disease progression, assessed up to 18 months
M-PFS
Metastasis-Progression Free Survival (M-PFS): Defined as the time from the date of initiating concurrent chemoradiotherapy at enrollment to the first occurrence of objective distant tumor progression after starting maintenance therapy or all-cause death, whichever comes first.
Time frame: From date of the first treatment to the first documented disease progression, assessed up to 18 months
OS
Overall Survival (OS): The time from the date of initiating study treatment at enrollment to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last known alive.
Time frame: From date of the first treatment to death due to any cause, assessed up to 18 months
DCR
Disease Control Rate (DCR): The proportion of patients with tumor shrinkage or stabilization maintained for a specified duration, including subjects with Complete Response (CR), Partial Response (PR), and Stable Disease (SD).
Time frame: From date of the first treatment to18 months
DoR
Duration of Response (DoR): The time from the date of confirmed CR or PR by imaging to the occurrence of disease progression or death without progression
Time frame: from the date of first documented CR or PR to disease progression or death, censored at last evaluable assessment; maximum follow-up of 18 months
ORR
Objective Response Rate (ORR): The proportion of subjects with tumor reduction achieving a predefined magnitude and maintained for a specified duration, including those with Complete Response (CR) and Partial Response (PR). Tumor objective response will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1).
Time frame: Confirmed objective response observed within 18 months from start of treatment
AE
Incidence of adverse events assessed by CTCAE v5.0
Time frame: From signing of informed consent through 30 days after last dose (or 90 days for serious AEs), assessed at the end of every cycle (each cycle = 21 days)
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