Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer
A Front-Line Window-of-Opportunity Phase 2 Study of Tarlatamab (Bispecific T Cell Engager: DLL3-CD3) in Patients With Extensive-Stage Small-Cell Lung Cancer
Sponsor: Asrar Alahmadi + Amgen
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
6-month progression-free survival (PFS)
Time frame: From the initiation of investigational therapy to progression, symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 months
Rapid progressive disease (PD) on tarlatamab rate probability (Interim analysis for futility monitoring)
Time frame: Within 4 weeks of starting tarlatamab
Secondary Endpoints
Rate of all adverse events (AEs)
Rate of all cytokine release syndrome
Rate of all immune effector cell associated neurotoxicity syndrome
Eligibility Criteria
Inclusion Criteria: * Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information * NOTE: HIPAA authorization may be included in the informed consent or obtained separately * Age ≥ 18 years at the time of consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2 * Have a histologically or cytologically documented new diagnosis of the extensive-stage (i.e., metastatic and/or recurrent) SCLC. Patients with multiple lung nodules and/or lymph node involvement that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan are allowed * Recurrent limited-stage SCLC disease after 6 months of completing standard-of-care systemic platinum-based chemotherapy and radiation can be considered after discussion with the sponsor * Measurable disease according to RECIST v 1.1 * All patients must have brain MRI. Subjects with brain metas…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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