Trials / Recruiting
RecruitingNCT06117774
Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Tarlatamab Therapy in Subjects With Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Who Have Not Progressed Following Concurrent Chemoradiation Therapy
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tarlatamab | Intravenous (IV) infusion |
| DRUG | Placebo | IV infusion |
Timeline
- Start date
- 2024-02-20
- Primary completion
- 2030-05-29
- Completion
- 2030-05-29
- First posted
- 2023-11-07
- Last updated
- 2026-04-15
Locations
204 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, China, Colombia, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Poland, Portugal, Romania, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06117774. Inclusion in this directory is not an endorsement.