Trials / Completed
CompletedNCT00518011
A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.
A Randomized, Open Label Study Comparing the Effect of First-line Therapy With Tarceva + Gemcitabine Versus Gemcitabine Monotherapy on Treatment Response in Treatment-naïve Patients With Advanced Non-small Cell Lung Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Erlotinib | 150 mg po daily |
| DRUG | Gemcitabine | As prescribed |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2009-02-01
- Completion
- 2009-02-01
- First posted
- 2007-08-17
- Last updated
- 2016-05-16
- Results posted
- 2016-04-01
Locations
14 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT00518011. Inclusion in this directory is not an endorsement.