- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01066884
A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer
August 22, 2016 updated by: Hoffmann-La Roche
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Balashikha, Russian Federation, 143900
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Krasnoyarsk, Russian Federation, 660133
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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150mg po daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of adverse events (AEs)
Time Frame: Length of patient on study (length of time of patient on study determined by investigator)
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Length of patient on study (length of time of patient on study determined by investigator)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Best Response Rate per investigator assessment
Time Frame: Length of patient on study (length of time of patient on study determined by investigator)
|
Length of patient on study (length of time of patient on study determined by investigator)
|
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
|
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
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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
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
February 4, 2010
First Submitted That Met QC Criteria
February 9, 2010
First Posted (Estimate)
February 10, 2010
Study Record Updates
Last Update Posted (Estimate)
August 24, 2016
Last Update Submitted That Met QC Criteria
August 22, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Erlotinib Hydrochloride
Other Study ID Numbers
- ML20569
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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