Text Size

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01287754
First received: January 24, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes

January 24, 2011
May 7, 2013
October 2011
December 2015   (final data collection date for primary outcome measure)
Progression-free survival, tumour assessments according to RECIST criteria [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01287754 on ClinicalTrials.gov Archive Site
  • Objective response rate, tumour assessments according to RECIST criteria [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Rate of EGFR mutations in non-small cell lung cancer patients, assessed at screening [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations
A 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 assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
150 mg daily orally
Experimental: Single Arm
Intervention: Drug: erlotinib [Tarceva]
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
24
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
  • Measurable disease according to RECIST criteria
  • ECOG performance status 0-2
  • Adequate haematological, renal and liver function

Exclusion Criteria:

  • Previous chemotherapy or therapy against EGFR for metastatic disease
  • History of another malignancy, except for in situ carcinoma of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
  • Symptomatic cerebral metastases
  • Pre-existing parenchymal lung disease such as pulmonary fibrosis
  • Concomitant use of coumarins
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01287754
ML25575
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

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