Back to resultsA Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer
Primary Purpose
Non-Squamous Non-Small Cell Lung Cancer
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
erlotinib [Tarceva]
Sponsored by
About this trial
This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- adult patients >= 18 years of age;
- inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer;
- ECOG performance status of 0-3;
- previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.
Exclusion Criteria:
- prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
- unstable systemic disease;
- any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
- any significant ophthalmologic abnormality.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs)
Secondary Outcome Measures
Best Response Rate per investigator assessment
Time to Progression (TTP)
Overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01066884
Brief Title
A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (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 safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
erlotinib [Tarceva]
Intervention Description
150mg po daily
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
Length of patient on study (length of time of patient on study determined by investigator)
Secondary Outcome Measure Information:
Title
Best Response Rate per investigator assessment
Time Frame
Length of patient on study (length of time of patient on study determined by investigator)
Title
Time to Progression (TTP)
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Title
Overall survival
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
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;
inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer;
ECOG performance status of 0-3;
previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.
Exclusion Criteria:
prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
unstable systemic disease;
any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
any significant ophthalmologic abnormality.
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
Balashikha
ZIP/Postal Code
143900
Country
Russian Federation
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer
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