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.
2 other identifiers
interventional
688
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2011
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2010
CompletedFirst Posted
Study publicly available on registry
November 30, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
October 5, 2015
CompletedMarch 14, 2016
February 1, 2016
3.2 years
November 29, 2010
August 28, 2015
February 16, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
14 Days
Secondary Outcomes (9)
Percentage of Participants With a Response by Best Objective Tumor Response
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
Months 0, 3, 6, 9, 12, 15, and 18
Survival Time in Months
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
Screening, Baseline and Final or Withdrawal Visit up to 34 months
Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D
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
- +4 more secondary outcomes
Study Arms (1)
Single Arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Unknown Facility
Belfast, BT47 6SB, United Kingdom
Unknown Facility
Belfast, BT9 7AB, United Kingdom
Unknown Facility
Bradford, BD9 6RJ, United Kingdom
Unknown Facility
Brighton, BN2 5BE, United Kingdom
Unknown Facility
Chelsmford, CM1 7ET, United Kingdom
Unknown Facility
Colchester, C03 3NB, United Kingdom
Unknown Facility
Dudley, DY1 2HQ, United Kingdom
Unknown Facility
Glasgow, G12 0YN, United Kingdom
Unknown Facility
Grimsby, DN33 2BA, United Kingdom
Unknown Facility
London, DD1 9SY, United Kingdom
Unknown Facility
London, N18 1QX, United Kingdom
Unknown Facility
London, NW1 2PG, United Kingdom
Unknown Facility
London, NW3 2QG, United Kingdom
Unknown Facility
London, SW17 0QT, United Kingdom
Unknown Facility
London, W6 8RF, United Kingdom
Unknown Facility
Newtownards, BT16 1RH, United Kingdom
Unknown Facility
Portadown, BT63 5QQ, United Kingdom
Unknown Facility
Rhyl, LL18 5UJ, United Kingdom
Unknown Facility
Sutton in Ashfield, NG17 4JL, United Kingdom
Unknown Facility
Truro, TR1 3LJ, United Kingdom
Unknown Facility
Westcliffe-on-sea, SS0 0RY, United Kingdom
Unknown Facility
York, BD20 6TD, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann- LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2010
First Posted
November 30, 2010
Study Start
March 1, 2011
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
March 14, 2016
Results First Posted
October 5, 2015
Record last verified: 2016-02