A Phase 3, Open-Label, Multicenter, Randomized Study of Subcutaneous vs Intravenous Tarlatamab in Participants with Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line chemotherapy (DeLLphi-315)

Condition studied

Relapsed Extensive-Stage Small Cell Lung Cancer After Platinum-based First-line chemotherapy

Investigational medicinal product(s)

Eligibility

Primary endpoint

Tarlatamab pharmacokinetic (PK) parameters: - area under the curve from cycle 2 day 1 to day 15 (AUC C2D1-D15) and - predose concentration on cycle 2 day 15 (Ctrough)

Endpoint detail

Objective response (OR)* derived utilizing investigator tumor assessments per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1),  Progression free survival (PFS)* derived utilizing investigator tumor assessments per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), Duration of response (DOR)* (only participants who have achieved OR will be evaluated for DOR) derived utilizing investigator tumor assessments per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), Disease control (DC)*derived utilizing investigator tumor assessments per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), Overall survival (OS), Incidence of treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs) including ≥ grade 3, serious, and fatal adverse events, and events of interest (EOI), Change from baseline to week 19 of the visual analogue scale (VAS) of the EuroQol-5 Dimension (EQ-5D-5L), Comparison of responses to:  selected questions from the PRO-CTCAE item bank  a single question from the FACT-G on symptom bother, Comparison of responses to TASQ (Therapy Administration Satisfaction Questionnaire), Incidence of anti-tarlatamab antibody formation