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NCT05267470 · ClinicalTrials.gov registry record · Phase 1
A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT05267470: Clinical Trial Phase 1 study, sponsored by Amgen.
NCT05267470 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 74 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05267470, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.
Primary Outcome
DLTs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and included the below if considered by the investigator to be related to study drug, excluding toxicities related to disease progression or intercurrent illness: Grade 3 thrombocytopenia for \> 7 days or with Grade \> 2 bleeding, vomiting/diarrhea for \> 3 days, fatigue; Grade ≥ 3 febrile neutropenia, nausea for \> 3 days; Grade 4 neutropenia, thrombocytopenia, anemia, ophthalmologic AE, laboratory val
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Paclitaxel
- DRUG Bemarituzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2022-03-29 |
| Est. Completion | 2024-05-28 |
| Phase | Phase 1 |
Why NCT05267470 stopped before completion
NCT05267470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05267470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05267470 about?
NCT05267470 is a clinical study titled "A Study of Bemarituzumab Monotherapy and Combination With Other Anti-cancer Therapy in SqNSCLC With FGFR2b Overexpression (FORTITUDE-201)". The primary objectives of this study are to evaluate the safety and tolerability of bemarituzumab monotherapy and combination with other anti-cancer therapies, and to determine the recommended phase 3 dose of bemarituzumab in combination with other anti-cancer therapies.
What is the current status of trial NCT05267470?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2022-03-29. Estimated completion is 2024-05-28.
What interventions are being tested in trial NCT05267470?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Docetaxel (DRUG), Paclitaxel (DRUG), Bemarituzumab (DRUG).
Who is sponsoring clinical trial NCT05267470?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05267470's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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