This single-arm phase II study aims to evaluate the efficacy and safety of lomustine combined with anlotinib in patients with extensive-stage small cell lung cancer resistant to second-line and above systemic treatment.
This is a single-arm phase II clinical study evaluating the efficacy and safety of lomustine combined with anlotinib in extensive-stage small cell lung cancer resistant to second-line and subsequent treatments. A total of 46 patients with extensive-stage small cell lung cancer who have received at least two lines of prior systemic therapy will be enrolled and treated with lomustine plus anlotinib. The primary endpoint is investigator-assessed objective response rate (ORR). Secondary endpoints include investigator-assessed progression-free survival (PFS), investigator-assessed disease control rate (DCR), intracranial response rate assessed per RANO criteria (RANO-IRR), investigator-assessed overall survival (OS), adverse events, quality of life (QOL) scores and safety profiles.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Objective Response Rate
Investigator-assessed ORR per RECIST 1.1 in ES-SCLC patients treated with Lomustine combined with anlotinib
Time frame: Baseline at screening, after every 2 treatment cycles (each cycle is 21 days), end of treatment, up to disease progression, assessed up to approximately 24 months
progression free survival
Time from first treatment to disease progression or death from any cause, whichever occurs first
Time frame: Date of first study treatment to date of disease progression or death from any cause, last follow-up, assessed up to approximately 24 months
Disease Control Rate (DCR)
According to RECIST 1.1, proportion of subjects achieving CR, PR, or stable disease (SD) in total enrolled population
Time frame: Time Frame: Baseline and after every 2 treatment cycles (each cycle is 21 days), up to disease progression, death, or study withdrawal, whichever occurs first,assessed up to approximately 24 months
Adverse Event (AE)
Record all new or worsening unfavorable medical events, grade and calculate incidence according to CTCAE 5.0
Time frame: From signing informed consent through study completion and safety follow-up, assessed up to approximately 24 months
Quality of Life Score(QOL Score)
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was adopted for patient self-assessment. The scale consists of 30 items, including 5 functional scales, 9 symptom scales and 1 global health status / quality of life scale. Each item is scored on a 1-4 Likert scale, and all scale scores are standardized to a range of 0-100. Higher scores in functional and global quality of life scales and lower scores in symptom scales indicate better quality of life and health status of patients.
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Time frame: At baseline, every 6 weeks during treatment until disease progression or death,assessed up to approximately 24 months