A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer
|ClinicalTrials.gov Identifier: NCT00701558|
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : May 19, 2016
Last Update Posted : June 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Metastatic||Drug: Erlotinib Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Erlotinib + Gemcitabine
Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.
150 mg po daily
Other Name: TarcevaDrug: Gemcitabine
1000 mg/m^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles
- Time to Disease Progression [ Time Frame: From the time of randomization until disease progression or death (up to 193 weeks)] ]Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
- Overall Response Rate (ORR) [ Time Frame: From the time of randomization until disease progression or death (up to 193 weeks) ]Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Overall Survival [ Time Frame: From the time of randomization until death (up to 193 weeks) ]Overall survival was defined as the interval between the day of randomization and the date of death from any cause.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701558
|Bucuresti, Romania, 022328|
|Study Director:||Clinical Trials||Hoffmann-La Roche|