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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01250119
First received: November 29, 2010
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This study will assess the prevalence of epidermal growth factor receptor (EGFR) mutations in newly diagnosed patients with locally advanced or metastatic non-s mall 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 rece ive Tarceva at a dose of 150 mg orally daily. Anticipated time on study treatmen t is until progressive disease or unacceptable toxicity occurs. Patients with ne gative EGFR mutation results will be offered treatment as per the centre's stand ard of care.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 129
Study Start Date: March 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: erlotinib [Tarceva]
150 mg daily, orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01250119

Locations
United Kingdom
Belfast, United Kingdom, BT47 6SB
Belfast, United Kingdom, BT9 7AB
Bradford, United Kingdom, BD9 6RJ
Brighton, United Kingdom, BN2 5BE
Chelsmford, United Kingdom, CM1 7ET
Colchester, United Kingdom, C03 3NB
Dudley, United Kingdom, DY1 2HQ
Glasgow, United Kingdom, G12 0YN
Grimsby, United Kingdom, DN33 2BA
London, United Kingdom, W6 8RF
London, United Kingdom, DD1 9SY
London, United Kingdom, N18 1QX
London, United Kingdom, SW17 0QT
London, United Kingdom, NW1 2PG
London, United Kingdom, NW3 2QG
Newtownards, United Kingdom, BT16 1RH
Portadown, United Kingdom, BT63 5QQ
Rhyl, United Kingdom, LL18 5UJ
Sutton in Ashfield, United Kingdom, NG17 4JL
Truro, United Kingdom, TR1 3LJ
Westcliffe-on-sea, United Kingdom, SS0 0RY
York, United Kingdom, BD20 6TD
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01250119     History of Changes
Other Study ID Numbers: ML25279, 2010-021120-96
Study First Received: November 29, 2010
Last Updated: July 21, 2014
Health Authority: United Kingdom: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Endothelial Growth Factors
Erlotinib
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014