- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01990261
A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment (STAR)
August 8, 2016 updated by: Hoffmann-La Roche
The Survival of Non-Small Cell Lung Carcinoma EGFR Non-mutated (Wild Type) Patients Treated With Erlotinib (TARceva) After the Failure of at Least One Chemotherapy Regimen
This study will evaluate the survival of non-small cell lung cancer (wild-type EGFR) participants treated with Tarceva after at least one failed chemotherapy treatment, and the impact of prior chemotherapy treatments.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
33
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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Bucharest, Romania, 022338
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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
Sampling Method
Probability Sample
Study Population
Adult participants diagnosed with locally advanced, metastatic or recurrent non-small cell lung carcinoma with wild-type EGFR.
Description
Inclusion Criteria:
- Adults >/= 18 years
- Histologically documented locally advanced, metastatic, or recurrent non-small cell lung carcinoma with wild-type EGFR eligible for Tarceva treatment.
- At least one failed chemotherapy treatment.
Exclusion Criteria:
- Unknown EGFR mutation status
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Erlotinib
Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
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Erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival Rate at Month 6
Time Frame: Month 6
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Month 6
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Survival Rate at Month 12
Time Frame: Month 12
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Month 12
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Progression Free Survival (PFS) at Month 6
Time Frame: From inclusion up to disease progression or death whichever occurs first (up to 6 months)
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PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first.
Disease progression was determined according to local treatment guidelines.
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From inclusion up to disease progression or death whichever occurs first (up to 6 months)
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Progression Free Survival (PFS) at Month 12
Time Frame: From inclusion up to disease progression or death whichever occurs first (up to 12 months)
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PFS is defined as the time from inclusion in the study to the disease progression or death whichever occurs first.
Disease progression was determined according to local treatment guidelines.
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From inclusion up to disease progression or death whichever occurs first (up to 12 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Up to 12 months
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OS is defined as time from first administration of study drug until death from any cause.
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Up to 12 months
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Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to 12 months
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An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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Up to 12 months
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Overall Survival According to Prior Chemotherapy Treatment.
Time Frame: Up to 12 months
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Prior chemotherapy treatment is presented as reported by the investigators.
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Up to 12 months
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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
May 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
October 31, 2013
First Submitted That Met QC Criteria
November 20, 2013
First Posted (Estimate)
November 21, 2013
Study Record Updates
Last Update Posted (Estimate)
September 16, 2016
Last Update Submitted That Met QC Criteria
August 8, 2016
Last Verified
June 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
- ML28496
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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