Observation and Evaluation of the Efficacy and Safety of Adalimumab Combined with Chemotherapy Followed by Radiotherapy or Radiotherapy Alone as First-Line Treatment for Limited-Stage Small Cell Lung Cancer
The study comprises two cohorts (A and B). Cohort A first receives two cycles of induction therapy combining PD-L1 inhibitors with chemotherapy, followed by two cycles of concurrent chemoradiotherapy and subsequent maintenance therapy with PD-L1 inhibitors. Cohort B first undergoes four cycles of concurrent chemoradiotherapy followed by maintenance therapy with PD-L1 inhibitors. Both cohorts continue treatment until disease progression or intolerable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Induction Phase Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks Etoposide: 100 mg/m², intravenous infusion, Days 1-3, every 3 weeks Platinum-based agent: Cisplatin 75 mg/m² or Carboplatin AUC 5, intravenous infusion on Day 1, every 3 weeks Radiotherapy: 45 Gy/30 fractions BID or 60-66 Gy/30 fractions QD. Maintenance Phase Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks
Concurrent chemoradiotherapy radiotherapy : 45 Gy/30 fractions BID or 60-66 Gy/30 fractions QD Etoposide: 100 mg/m², intravenous infusion, Days 1-3, every 3 weeks Platinum-based agent: Cisplatin 75 mg/m² or Carboplatin AUC 5, intravenous infusion on Day 1, every 3 weeks Maintenance therapy Adebrelimab: 1200 mg, intravenous infusion, every 3 weeks
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
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
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
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