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A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)
NCT05060016 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05060016 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, North Carolina, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05060016?
The interventions under investigation include: Tarlatamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05060016?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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