Study Evaluating Tarlatamab in Chinese Participants With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
Phase 2a Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of Tarlatamab in Chinese Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-307)
Sponsor: Amgen
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off
Secondary Endpoints
Duration of Response (DOR) Based on BICR Per RECIST 1.1
Disease Control (DC) Based on BICR Per RECIST 1.1
Duration of DC Based on BICR Per RECIST 1.1
Eligibility Criteria
Inclusion Criteria: * Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Participant must be a resident in China, and of Chinese ancestry ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent. * Histologically or cytologically confirmed small cell lung cancer. * Extensive-stage SCLC participants who progressed on or recurred following 1 platinum-based regimen as 1L therapy (including a PD-1/PD-\[L\]1) and at least 1 other prior line of therapy. * Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of study drug. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Minimum life expectancy of 12 weeks. * Adequate organ function. Exclusion Criteria: Disease Related * Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transfor…
Read full criteria on CT.gov →✦ Analyst Commentary
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