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.

Hoffmann-La Roche688 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

688

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (22)

Unnamed facility

Belfast, United Kingdom

Unnamed facility

Belfast, United Kingdom

Unnamed facility

Bradford, United Kingdom

Unnamed facility

Brighton, United Kingdom

Unnamed facility

Chelsmford, United Kingdom

Unnamed facility

Colchester, United Kingdom

Unnamed facility

Dudley, United Kingdom

Unnamed facility

Glasgow, United Kingdom

Unnamed facility

Grimsby, United Kingdom

Unnamed facility

London, United Kingdom

...and 12 more locations

Outcomes

Primary Outcomes

Percentage of Participants Who Tested Positive for EGFR Mutations

All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.

Time frame: 14 days

Percentage of Participants With EGFR Mutations by Subgroup

Incidence of EGFR mutations were summarized with respect to different subgroups as follows: (1) equals (=) Histopathology, (2) = Stage of disease, (3) = Age at consent, (4) = Gender, (5) = Race, (6) = Smoking history.

Time frame: 14 Days

Secondary Outcomes

Percentage of Participants With a Response by Best Objective Tumor Response

Best objective response was defined as the best response recorded from the start of treatment until disease progression/recurrence. Tumor response was assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1". Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Partial Response (PR): At least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this may include the baseline sum). The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.

Time frame: 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

Probability of Being Alive and Free of Progression by Timepoint

Progression Free Survival (PFS) was defined as the interval (number of days) from the trial treatment start date to the earlier of the date of the first tumor response assessment of PD or the date of death by any cause. Participants who experienced neither of these events or who were lost to followup at the time of the analysis were censored at date of last contact. PFS was summarized according to the Kaplan-Meier method.

Time frame: Months 0, 3, 6, 9, 12, 15, and 18

Survival Time in Months

Duration of time in months from Screening until Death due to any cause.

Time frame: 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

Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument

The EQ-5D contains a descriptive system that measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D also contains a visual analog scale (EQ-VAS), which records the respondent's self-rated health status on a vertical graduated visual analog scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A negative change indicates improvement.

Time frame: Screening, Baseline and Final or Withdrawal Visit up to 34 months

Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D

The EQ-5D contains a descriptive system which measures 5 health dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The participants were required to rate their mobility as the following categories: Category 1. I have no problems in walking about; Category 2. I have some problems in walking about; Category 3. I am confined to bed.