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NCT02228369 · ClinicalTrials.gov registry record · Phase 1
Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
NCT02228369: Completed Phase 1 study, sponsored by AstraZeneca.
NCT02228369 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 108 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02228369, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
Study Summary
This is the first time in patient study to assess the safety, tolerability and preliminary efficacy of AZD3759 in patients with advanced Non Small Cell Lung Cancer (NSCLC) In this study, patients with Leptomeningeal Metastasis and Brain Metastasis may also be enrolled to assess the anti-tumour efficacy, safety, pharmacokinetics and potential biological activity of AZD9291
Primary Outcome
Adverse events will be collected from Informed consent until the end of the follow-up period which is defined as 28 days (+7 days) after study treatment is discontinued.Physical exam (screening, single dosing day, Day 1 of every 3-week cycle of multiple dosing and treatment discontinuation). ECG and vital signs (screening, Day 1 and 2 of Cycle 0 for AZD3759 cohorts, Day 8 of Cycle 1 for AZD3759 cohorts, Day 1 of every 3-week cycle, treatment discontinuation, and if occurrence of any cardiac adve
Interventions
- DRUG AZD9291
- DRUG AZD3759
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2014-11-05 |
| Est. Completion | 2020-10-28 |
| Phase | Phase 1 |
What the finished NCT02228369 record still lists
NCT02228369 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 2 interventions - of which AZD9291 is the first listed.
NCT02228369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02228369 about?
NCT02228369 is a clinical study titled "Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors, AZD3759 or AZD9291, in Patients Who Have Advanced Non-Small Cell Lung Cancer". This is the first time in patient study to assess the safety, tolerability and preliminary efficacy of AZD3759 in patients with advanced Non Small Cell Lung Cancer (NSCLC) In this study, patients with Leptomeningeal Metastasis and Brain Metastasis may also be enrolled to assess the anti-tumour effic...
What is the current status of trial NCT02228369?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2014-11-05. Estimated completion is 2020-10-28.
What interventions are being tested in trial NCT02228369?
The interventions under investigation include: AZD9291 (DRUG), AZD3759 (DRUG).
Who is sponsoring clinical trial NCT02228369?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02228369's enrollment target sits among peer trials
108 523rd of 2000 higher than 1,470 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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