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.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01250119
First received: November 29, 2010
Last updated: April 7, 2014
Last verified: April 2014

November 29, 2010
April 7, 2014
March 2011
May 2014   (final data collection date for primary outcome measure)
Prevalence of epidermal growth factor receptor (EGFR) mutation in NSCLC patients in the UK [ Time Frame: 18 months (diagnostic phase) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01250119 on ClinicalTrials.gov Archive Site
  • Quality of life (Euro Qol Group EQ-5D questionnaire) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Overall response rate (tumour assessments as per centre standard of care according to RECIST criteria) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Progression-free survival (tumour assessments as per centre standard of care according to RECIST criteria) [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 30 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.
Assess the Incidence of Mutations in the Tyrosine Kinase Domain of the Endothelial Growth Factor Receptor in UK Patients With Newly Diagnosed Metastatic or Recurrent Non-small Cell Lung Cancer and to Investigate the Quality of Life of These Patients Undergoing First-line Therapy With Erlotinib.

This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with positive EGFR mutation results will enter an open-label, single arm study to evaluate progression-free survival and quality of life with first-line Tarceva (erlotinib) therapy. Patients will receive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatment is until progressive disease or unacceptable toxicity occurs. Patients with negative EGFR mutation results will be offered treatment as per the centre's standard of care.

Not Provided
Interventional
Phase 2
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
129
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • 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:

  • Previous treatment for NSCLC with chemotherapy or therapy against EGFR, either with antibody or small molecule (tyrosine kinase inhibitor)
  • Symptomatic cerebral metastases
  • Pregnant or lactating women
  • Any other concomitant anti-cancer therapy (until disease progression and discontinuation of Tarceva therapy)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01250119
ML25279, 2010-021120-96
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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