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A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01260181
First received: December 13, 2010
Last updated: March 15, 2017
Last verified: March 2017

December 13, 2010
March 15, 2017
March 31, 2011
December 31, 2017   (Final data collection date for primary outcome measure)
Percentage of Participants with Objective Response (Complete Response [CR]/Partial Response [PR]) Based on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 [ Time Frame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) ]
Overall Response Rate: tumour assessments by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST 1.1 criteria [ Time Frame: approximately 3.5 years ]
Complete list of historical versions of study NCT01260181 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) Based on CT or MRI According to RECIST v 1.1 [ Time Frame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) ]
  • Overall Survival [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline up to 5 years ]
  • Percentage of Participants with Epidermal Growth Factor Receptor (EGFR) Mutation in Study Population [ Time Frame: Screening (21 days prior to Day 1) ]
  • Median Time Taken for the First Response Based on RECIST v 1.1 as Determined by the Investigator [ Time Frame: Baseline up to 5 years (assessed at Baseline, every 8 weeks until disease progression or death or end of treatment period [up to 5 years]) ]
  • Progression-free survival: tumour assessments by CT or MRI according to RECIST 1.1 criteria [ Time Frame: approximately 3.5 years ]
  • Overall Survival [ Time Frame: approximately 3.5 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ]
  • Epidermal Growth Factor Receptor (EGFR) mutation rate in study population, assessed at screening [ Time Frame: approximately 12 months ]
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Not Provided
 
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
Phase II, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor
This single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Non-Squamous Non-Small Cell Lung Cancer
Drug: Erlotinib
Erlotinib 150 mg tablet will be given orally daily.
Experimental: Erlotinib
Participants will receive erlotinib 150 millgrams (mg) orally daily until disease progression.
Intervention: Drug: Erlotinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 31, 2018
December 31, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Locally advanced or metastatic NSCLC with EGFR mutations
  • Measurable disease according to RECIST criteria
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Previous chemotherapy or therapy against EGFR for metastatic disease
  • Symptomatic cerebral metastases
  • Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
  • History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
  • Concomitant use of coumarins
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
 
NCT01260181
ML25434
2010-022509-17
Not Provided
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP