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. - Full Text View

Purpose

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.

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:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

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, N18 1QX

London, United Kingdom, DD1 9SY

London, United Kingdom, W6 8RF

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:	March 2, 2015
Health Authority:	United Kingdom: Ministry of Health

Additional relevant MeSH terms:


Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases	Respiratory Tract Neoplasms Thoracic Neoplasms Erlotinib Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on March 03, 2015