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Phase 2 Safety and Efficacy Evaluation of AL8326 in ≥2nd Line SCLC
Trial Status: closed to accrual
This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral
AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent,
advanced, or metastatic small cell lung cancer (SCLC) patients who need ≥2nd line
treatment .
Inclusion Criteria
Male or female, 18 years of age or older
ECOG performance status of 0 or 1
Histologically or cytologically confirmed SCLC
Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1
Have a life expectancy of at least 3 months Major
Exclusion Criteria
Serious, non-healing wound, ulcer or bone fracture
Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment
Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease
Hemoptysis within 3 months prior to enrollment
Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it. More information available upon request
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05363280.
