Trials / Completed
CompletedNCT00949650
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 345 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pemetrexed | Pemetrexed IV given once every 3 weeks for up to 6 cycles |
| DRUG | BIBW 2992 | BIBW 2992 once daily until progression |
| DRUG | Cisplatin | Cisplatin IV given once every 3 weeks for up to 6 cycles |
Timeline
- Start date
- 2009-08-14
- Primary completion
- 2012-02-09
- Completion
- 2017-03-16
- First posted
- 2009-07-30
- Last updated
- 2018-04-06
- Results posted
- 2013-11-19
Locations
133 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Malaysia, Peru, Philippines, Romania, Russia, South Korea, Taiwan, Thailand, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00949650. Inclusion in this directory is not an endorsement.