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A Study to Assess the Survival of Non-small Cell Lung Cancer Patients Treated With Tarceva After Failed Chemotherapy Treatment (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01990261
Recruitment Status : Terminated
First Posted : November 21, 2013
Results First Posted : July 28, 2016
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Non-Squamous Non-Small Cell Lung Cancer Drug: Erlotinib

Study Design
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Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Study Start Date : May 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Drug: Erlotinib
Erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
Other Name: Tarceva


Outcome Measures
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Primary Outcome Measures :
  1. Survival Rate at Month 6 [ Time Frame: Month 6 ]
  2. Survival Rate at Month 12 [ Time Frame: Month 12 ]
  3. Progression Free Survival (PFS) at Month 6 [ Time Frame: From inclusion up to disease progression or death whichever occurs first (up to 6 months) ]
    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.

  4. Progression Free Survival (PFS) at Month 12 [ Time Frame: From inclusion up to disease progression or death whichever occurs first (up to 12 months) ]
    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.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 12 months ]
    OS is defined as time from first administration of study drug until death from any cause.

  2. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to 12 months ]
    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.

  3. Overall Survival According to Prior Chemotherapy Treatment. [ Time Frame: Up to 12 months ]
    Prior chemotherapy treatment is presented as reported by the investigators.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult participants diagnosed with locally advanced, metastatic or recurrent non-small cell lung carcinoma with wild-type EGFR.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990261


Locations
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Romania
Bucharest, Romania, 022338
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01990261    
Other Study ID Numbers: ML28496
First Posted: November 21, 2013    Key Record Dates
Results First Posted: July 28, 2016
Last Update Posted: September 16, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action