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NCT00567359 · ClinicalTrials.gov registry record · Phase 2
Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT00567359: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT00567359 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00567359, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor. Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.
Primary Outcome
The number of participants alive and free from disease recurrence 2 years after enrollment. Participants were monitored for disease recurrence with the use of surveillance radiographs. When possible and medically appropriate, tissue biopsies were obtained to prove recurrence.
Interventions
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2007-12 |
| Est. Completion | 2017-12 |
| Phase | Phase 2 |
What the finished NCT00567359 record still lists
NCT00567359 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which Erlotinib is the first listed.
NCT00567359 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00567359 about?
NCT00567359 is a clinical study titled "Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR". In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/o...
What is the current status of trial NCT00567359?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2007-12. Estimated completion is 2017-12.
What interventions are being tested in trial NCT00567359?
The interventions under investigation include: Erlotinib (DRUG).
Who is sponsoring clinical trial NCT00567359?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00567359's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 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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