A Study to Assess the Incidence of EGFR Mutation in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-Small Cell Lung Cancer in the UK, And of Tarceva (Erlotinib) as First-Line Therapy in EGFR Mutation Positive Patients.
NCT ID: NCT01250119
Last Updated: 2016-03-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
688 participants
INTERVENTIONAL
2011-03-31
2014-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
NCT01260181
A Study of Tarceva (Erlotinib) as First Line Therapy in Participants With Non-Small Cell Lung Cancer Harbouring Epidermal Growth Factor Receptor (EGFR) Mutations
NCT01310036
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
NCT01287754
A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
NCT01609543
A Study of the Effect of R1507 in Combination With Tarceva (Erlotinib) on Progression-Free Survival in Patients With Stage IIIb/IV Non-Small Cell Lung Cancer (NSCLC) Having Received Tarceva Monotherapy.
NCT00773383
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single Arm
erlotinib [Tarceva]
150 mg daily, orally
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
erlotinib [Tarceva]
150 mg daily, orally
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Locally advanced or metastatic (stage IIIB/IV) non-small cell lung cancer (NSCLC)
* ECOG performance status 0-3
* Treatment phase: histologically confirmed EGFR exon 19 deletion or exon 21 mutation in the diagnostic phase of the study
* Adequate haematological, liver and renal function
* Female patients must be postmenopausal, surgically sterile, or agree to use a barrier method of contraception
* Male patients must be surgically sterile or agree to use a barrier method of contraception
Exclusion Criteria
* Symptomatic cerebral metastases
* Pregnant or lactating women
* Any other concomitant anti-cancer therapy (until disease progression and discontinuation of Tarceva therapy)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Belfast, , United Kingdom
Belfast, , United Kingdom
Bradford, , United Kingdom
Brighton, , United Kingdom
Chelsmford, , United Kingdom
Colchester, , United Kingdom
Dudley, , United Kingdom
Glasgow, , United Kingdom
Grimsby, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Newtownards, , United Kingdom
Portadown, , United Kingdom
Rhyl, , United Kingdom
Sutton in Ashfield, , United Kingdom
Truro, , United Kingdom
Westcliffe-on-sea, , United Kingdom
York, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-021120-96
Identifier Type: -
Identifier Source: secondary_id
ML25279
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.