NCT05060016

A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)

A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301).

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to: * evaluate safety and efficacy (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST 1.1\] by investigator) of 2 dose levels of tarlatamab for Part 1 only * evaluate anti-tumor activity of tarlatamab as determined by objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR) for Part 1 and 2 * evaluate safety of reduced mandatory monitoring period in Cycle 1 at selected dose of tarlatamab for Part 3

Conditions

• Relapsed/Refractory Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tarlatamab	Intravenous (IV) infusion

Timeline

• Start date: 2021-12-01
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2021-09-28
• Last updated: 2025-12-22

Locations

80 sites across 18 countries: United States, Austria, Belgium, Denmark, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Portugal, Singapore, South Korea, Spain, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study