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NCT05060016 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)
A Phase 2 study of Relapsed/Refractory Small Cell Lung Cancer, sponsored by Amgen.
- Active
- Registry status
- Phase 2
- Development phase
- 222
- Enrollment target
- 20
- Study locations
NCT05060016 is a Phase 2 study of Relapsed/Refractory Small Cell Lung Cancer that is active but no longer recruiting, run by Amgen. The registered enrollment target is 222 participants. The trial reports 20 study locations across 15 states.
The verdict
NCT05060016, a Phase 2 study of Relapsed/Refractory Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 222 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Tarlatamab
Study Locations (20)
Other
- Universitaetsklinikum Krems - Krems
- Landeskrankenhaus Salzburg - Salzburg
- Universitair Ziekenhuis Gent - Ghent
- Grand Hopital de Charleroi - Site Saint Joseph - Gilly
North Carolina
- Duke University Medical Center - Durham
- Wake Forest Baptist Comprehensive Cancer Research Center - Winston-Salem
Ohio
- Oncology Hematology Care Inc - Cincinnati
- University Hospitals Cleveland Medical Center - Cleveland
Alabama
- University of Alabama at Birmingham - Birmingham
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Delaware
- Christiana Care Health Services - Newark
Florida
- Moffitt Cancer Center - Tampa
Georgia
- Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05060016
The ClinicalTrials.gov registry entry for NCT05060016 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Relapsed/Refractory Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Tarlatamab is the first listed.
NCT05060016 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT05060016 about?
NCT05060016 is a clinical study titled "A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)". 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) p...
What is the current status of trial NCT05060016?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2021-12-01. Estimated completion is 2027-12-30.
What conditions does trial NCT05060016 study?
This clinical trial studies the following conditions: Relapsed/Refractory Small Cell Lung Cancer.
What interventions are being tested in trial NCT05060016?
The interventions under investigation include: Tarlatamab (DRUG).
Who is sponsoring clinical trial NCT05060016?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05060016 being conducted?
This trial has 20 study locations across Alabama, Arkansas, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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