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NCT03318939 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation
A Phase 2 study, sponsored by Spectrum Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 648
- Enrollment target
NCT03318939: Clinical Trial Phase 2 study, sponsored by Spectrum Pharmaceuticals.
NCT03318939 is a Phase 2 study that was terminated before completion, run by Spectrum Pharmaceuticals. The registered enrollment target is 648 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (387% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03318939, a Phase 2 study, was terminated before completion, sponsored by Spectrum Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 648 participants
- Enrollment target
Study Summary
This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were added with Amendment 2 (Cohorts 5, 6 and 7).
Primary Outcome
ORR was defined as the percentage of participants whose best overall response (BOR) was confirmed to be complete response (CR) or partial response (PR) from the first dose of poziotinib until the last tumor assessment on study. ORR was assessed by the Independent Radiologic Review Committee according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all non-nodal target lesions. Any pathological lymph nodes must have become normal
Interventions
- DRUG Poziotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 648 participants |
| Start Date | 2017-10-11 |
| Est. Completion | 2023-04-03 |
| Phase | Phase 2 |
Why NCT03318939 stopped before completion
NCT03318939 is an interventional study that assigns participants to a tested intervention. The registered 648 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (387% higher).
The record links to 0 conditions, and to 1 intervention - of which Poziotinib is the first listed.
NCT03318939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03318939 about?
NCT03318939 is a clinical study titled "Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation". This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven participant cohorts for up to 603 previously treated and treatment-naïve NSCLC participant. Cohorts 3 and 4 were added with Amendment 1 and three additional cohorts were adde...
What is the current status of trial NCT03318939?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 648 participants. The study started on 2017-10-11. Estimated completion is 2023-04-03.
What interventions are being tested in trial NCT03318939?
The interventions under investigation include: Poziotinib (DRUG).
Who is sponsoring clinical trial NCT03318939?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03318939's enrollment target sits among peer trials
648 50th of 2000 higher than 1,951 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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