Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00556322 |
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva and that of standard of care chemotherapy in patients with advanced, recurrent, or metastatic NSCLC experiencing disease progression after failure of platinum-based chemotherapy.Eligible patients will be randomized to receive either Tarceva 150mg po daily, or comparator (either Alimta 500mg/m2 every 3 weeks, or Taxotere 75mg/m2 every 3 weeks). The anticipated time on study treatment is until disease progression ,and the target sample size is 500+ individuals.
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Cancer |
Drug: erlotinib [Tarceva] Drug: Alimta or Taxotere |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Randomized Study to Evaluate the Effect of Tarceva, Compared With Alimta (Pemetrexed) or Taxotere (Docetaxel),on Survival in Patients With Advanced, Recurrent or Metastatic Non-Small Cell Lung Cancer Who Have Experienced Disease Progression During Platinum-Based Chemotherapy |
Estimated Enrollment: | 650 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | August 2014 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: erlotinib [Tarceva]
150mg po daily
|
2: Active Comparator |
Drug: Alimta or Taxotere
500mg/m2 / 3 weeks (Alimta) or 75mg/m2 / 3 weeks (Taxotere)
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Please reference Study ID Number: BO18602 | 973-235-5000 | |
Contact: or | 800-526-6367 (FOR US ONLY) |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | BO18602 |
Study First Received: | November 9, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00556322 |
Health Authority: | Slovenia: Ministry of Health |
Thoracic Neoplasms Erlotinib Non-small cell lung cancer Disease Progression Recurrence Carcinoma Folic Acid |
Docetaxel Pemetrexed Respiratory Tract Diseases Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |
Folic Acid Antagonists Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses |