Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients
A Phase II Clinical Trial of Tarlatamab as Maintenance Treatment After Sequential Chemo-radiotherapy for Limited Stage SCLC Patients Not Eligible for Concurrent Chemo-radiotherapy
Sponsor: Fundación GECP
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-free survival
Time frame: From date of enrollment until the date of last follow up, assessed up to 24 months.
Secondary Endpoints
Objective response rate (ORR)
Overall Survival (OS)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically documented new diagnosis of LS-SCLC by histology or cytology from brushing, washing, or needle aspiration. Mixed tumors are not eligible. * Patients who: 1. were treated with sequential chemo-radiotherapy 2. were treated only with chemotherapy * Have at least one lesion that meets criteria for being measurable or non-measurable, as defined by RECIST 1.1. * Has completed chemo-radiation or chemotherapy alone without progression of disease per RECIST v1.1 * Be male or female ≥18 years of age inclusive, on the day of signing informed consent. * Have a life expectancy of at least 3 months from the study start. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to the first dose of study intervention. * Toxicities attributed to chemo-radiotherapy treatment have to be resolved to grade ≤1, unless otherwise specified. * No clinically significant electrocardiogram (ECG) findings * Corr…
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