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NCT00949650 · ClinicalTrials.gov registry record · Phase 3
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 345
- Enrollment target
NCT00949650: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT00949650 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 345 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00949650, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 345 participants
- Enrollment target
Study Summary
This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.
Primary Outcome
PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.
Interventions
- DRUG Cisplatin
- DRUG Pemetrexed
- DRUG BIBW 2992
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 345 participants |
| Start Date | 2009-08-14 |
| Est. Completion | 2017-03-16 |
| Phase | Phase 3 |
What the finished NCT00949650 record still lists
NCT00949650 is an interventional study that assigns participants to a tested intervention. The registered 345 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT00949650 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00949650 about?
NCT00949650 is a clinical study titled "BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation". This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplat...
What is the current status of trial NCT00949650?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 345 participants. The study started on 2009-08-14. Estimated completion is 2017-03-16.
What interventions are being tested in trial NCT00949650?
The interventions under investigation include: Cisplatin (DRUG), Pemetrexed (DRUG), BIBW 2992 (DRUG).
Who is sponsoring clinical trial NCT00949650?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00949650's enrollment target sits among peer trials
345 1050th of 2000 higher than 951 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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