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NCT00525148 · ClinicalTrials.gov registry record · Phase 2
LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations
A Phase 2 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 2
- Development phase
- 129
- Enrollment target
NCT00525148 is a Phase 2 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 129 participants.
The verdict
NCT00525148, a Phase 2 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 129 participants
- Enrollment target
Study Summary
The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by RECIST criteria in patients with advanced NSCLC Stage IIIB or IV whose tumors harbor activating mutations within exon 18 to exon 21 of the EGFR receptor. Patients progressing or relapsing after one prior cytotoxic chemotherapy regimen as well as chemotherapy naïve patients (only in stage 2) will be allowed to enter into the trial.
Interventions
- DRUG BIBW 2992
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2007-08 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00525148
The ClinicalTrials.gov registry entry for NCT00525148 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BIBW 2992 is the first listed.
NCT00525148 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00525148 about?
NCT00525148 is a clinical study titled "LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations". The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by RECIST criteria in patients with advanced NSCLC Stage IIIB or IV whose tumors harbor activating mutations within exon 18 to exo...
What is the current status of trial NCT00525148?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 129 participants. The study started on 2007-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00525148?
The interventions under investigation include: BIBW 2992 (DRUG).
Who is sponsoring clinical trial NCT00525148?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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