Back to resultsA 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
Primary Purpose
Non-small Cell Lung Cancer Metastatic
Status
Completed
Phase
Phase 2
Locations
Romania
Study Type
Interventional
Intervention
Erlotinib
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer Metastatic
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
- no previous systemic chemotherapy, radiation therapy or immunotherapy;
- Eastern Cooperative Oncology Group (ECOG) >=2.
Exclusion Criteria:
- prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
- active, non-controlled systemic disease;
- any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Erlotinib + Gemcitabine
Arm Description
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.
Outcomes
Primary Outcome Measures
Time to Disease Progression
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)
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.
Secondary Outcome Measures
Overall Survival
Overall survival was defined as the interval between the day of randomization and the date of death from any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00701558
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Erlotinib + Gemcitabine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
150 mg po daily
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1000 mg/m^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles
Primary Outcome Measure Information:
Title
Time to Disease Progression
Description
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.
Time Frame
From the time of randomization until disease progression or death (up to 193 weeks)]
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
From the time of randomization until disease progression or death (up to 193 weeks)
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the interval between the day of randomization and the date of death from any cause.
Time Frame
From the time of randomization until death (up to 193 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
no previous systemic chemotherapy, radiation therapy or immunotherapy;
Eastern Cooperative Oncology Group (ECOG) >=2.
Exclusion Criteria:
prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
active, non-controlled systemic disease;
any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
12. IPD Sharing Statement
Learn more about this trial
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
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