Clinical Trial: NCT05060016
A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Amgen |
| Information Provided By: | Amgen |
| Last Update Posted: | 2026-07-22 |
Study Overview
Brief 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
Official Title
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).
Conditions
Relapsed/Refractory Small Cell Lung Cancer
Intervention / Treatment
- Drug: Tarlatamab
Other Study ID Numbers
- 20200491
- 2024-511837-37
Start Date (Actual)
2021-12-01
Primary Completion Date (Estimated)
2027-12-30
Study Completion Date (Estimated)
2027-12-30
Enrollment (Actual)
222
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Amgen |
| Information Provided By: | Amgen |
| Last Update Posted: | 2026-07-22 |
Study Overview
Brief 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
Official Title
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).
Conditions
Relapsed/Refractory Small Cell Lung Cancer
Intervention / Treatment
- Drug: Tarlatamab
Other Study ID Numbers
- 20200491
- 2024-511837-37
Start Date (Actual)
2021-12-01
Primary Completion Date (Estimated)
2027-12-30
Study Completion Date (Estimated)
2027-12-30
Enrollment (Actual)
222
Study Type
Interventional
Phase
Phase 2