Clinical trial NCT01250119: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-11-30
Enrollment: 688
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Percentage of Participants Who Tested Positive for EGFR Mutations
timeFrame: 14 days
measure: Percentage of Participants With EGFR Mutations by Subgroup
timeFrame: 14 Days
Secondary outcomes:
measure: Percentage of Participants With a Response by Best Objective Tumor Response
timeFrame: Screening, Day 1 of each 6 week visit starting from Visit 3 until PD, Death, Unacceptable Toxicity or Withdrawal of Consent up to 34 months
measure: Probability of Being Alive and Free of Progression by Timepoint
timeFrame: Months 0, 3, 6, 9, 12, 15, and 18
measure: Survival Time in Months
timeFrame: Baseline, Day 1 of each 6-week visit starting from Visit 3 until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
measure: Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument
timeFrame: Screening, Baseline and Final or Withdrawal Visit up to 34 months
measure: Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D
timeFrame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
measure: Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D
timeFrame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
measure: Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D
timeFrame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
measure: Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D
timeFrame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
measure: Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D
timeFrame: Baseline (Visit 1), Days 10 to 14 (Visit 2), Day 1 of every 6 weeks until PD, Death, Unacceptable toxicity or Withdrawal of consent up to 34 months
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
city: Belfast
country: United Kingdom
city: Bradford
country: United Kingdom
city: Brighton
country: United Kingdom
city: Chelsmford
country: United Kingdom
city: Colchester
country: United Kingdom
city: Dudley
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Grimsby
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Newtownards
country: United Kingdom
city: Portadown
country: United Kingdom
city: Rhyl
country: United Kingdom
city: Sutton in Ashfield
country: United Kingdom
city: Truro
country: United Kingdom
city: Westcliffe-on-sea
country: United Kingdom
city: York
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: