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NCT01532089 · ClinicalTrials.gov registry record · Phase 2
Erlotinib Hydrochloride With or Without Bevacizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
A Phase 2 study, sponsored by Academic and Community Cancer Research United.
- Completed
- Registry status
- Phase 2
- Development phase
- 88
- Enrollment target
NCT01532089: Completed Phase 2 study, sponsored by Academic and Community Cancer Research United.
NCT01532089 is a Phase 2 study that has completed, run by Academic and Community Cancer Research United. The registered enrollment target is 88 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01532089, a Phase 2 study, has completed, sponsored by Academic and Community Cancer Research United.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 88 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well erlotinib hydrochloride (Tarceva) with or without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may block tumor growth in different ways by targeting certain cells. Bevacizumab may also stop the growth of NSCLC by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether erlotinib hydrochloride is more effective when given alone or with bevacizumab in treating patients with NSCLC.
Primary Outcome
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The median and 95% confidence intervals are estimated u
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Bevacizumab
- DRUG Erlotinib
- DRUG Erlotinib Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2012-03-16 |
| Est. Completion | 2020-08-18 |
| Phase | Phase 2 |
What the finished NCT01532089 record still lists
NCT01532089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01532089 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01532089 about?
NCT01532089 is a clinical study titled "Erlotinib Hydrochloride With or Without Bevacizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations". This randomized phase II trial studies how well erlotinib hydrochloride (Tarceva) with or without bevacizumab (Avastin) works in treating patients with stage IV non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. Erlotinib hydrochloride may stop the growth of t...
What is the current status of trial NCT01532089?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2012-03-16. Estimated completion is 2020-08-18.
What interventions are being tested in trial NCT01532089?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Bevacizumab (BIOLOGICAL), Erlotinib (DRUG), Erlotinib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT01532089?
This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01532089's enrollment target sits among peer trials
88 803rd of 2000 higher than 1,191 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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