This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer.
This study plans to recruit 40 patients with extensive-stage small cell lung disease who have not received treatment, observe and evaluate the effectiveness and safety of adebrelimab combined with famitinib and chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
6-month progression-free survival
Proportion of disease progression or death from randomization to 6 months of treatment.
Time frame: up to 6 months
12-month progression-free survival
Proportion of disease progression or death from randomization to 12 months of treatment.
Time frame: up to 12 months
Objective Response Rate
Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.
Time frame: up to 24 months
Disease control rate
Disease Control Rate, determined using RECIST v1.1 criteria.
Time frame: up to 24 months
Overall Survival
Defined as the time from randomization to death from any cause.
Time frame: up to 24 months
AEs
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Time frame: up to 24 months
QoL
Defined as time from randomization to deterioration on each of the EORTC QLQ-C30 symptom subscales
Time frame: up to 24 months
Progression-Free-Survival
Defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first.
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Time frame: up to 24 months