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: February 16, 2016
Last verified: February 2016
  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-Squamous Non-Small Cell Lung Cancer
Drug: erlotinib [Tarceva]
Phase 2

Study Type: Interventional
Study Design: 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:
  • Percentage of Participants Who Tested Positive for EGFR Mutations [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    All participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletion or exon 21 mutations.

  • Percentage of Participants With EGFR Mutations by Subgroup [ Time Frame: 14 Days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants With a Response by Best Objective Tumor Response [ 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 ] [ Designated as safety issue: No ]
    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.

  • Probability of Being Alive and Free of Progression by Timepoint [ Time Frame: Months 0, 3, 6, 9, 12, 15, and 18 ] [ Designated as safety issue: No ]
    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.

  • Survival Time in Months [ 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 ] [ Designated as safety issue: No ]
    Duration of time in months from Screening until Death due to any cause.

  • Quality of Life Assessment Using EuroQol(EQ) 5D Visual Analog Score (VAS) Instrument [ Time Frame: Screening, Baseline and Final or Withdrawal Visit up to 34 months ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Problems With Mobility as Assessed Using the EQ-5D [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Problems With Self-Care as Assessed Using the EQ-5D [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 self-care as the following categories: Category 1. I have no problems with self-care; Category 2. I have some problems washing or dressing myself; Category 3. I am unable to wash or dress myself.

  • Percentage of Participants With Problems With Usual Activities as Assessed Using the EQ-5D [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 ability to perform usual activities as the following categories: Category 1. I have no problems with performing my usual activities; Category 2. I have some problems with performing my usual activities; Category 3. I am unable to perform my usual activities.

  • Percentage of Participants With Pain/Discomfort as Assessed Using the EQ-5D [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 pain as the following categories: Category 1. I have no pain or discomfort; Category 2. I have moderate pain or discomfort; Category 3. I have extreme pain or discomfort.

  • Percentage of Participants With Anxiety/Depression as Assessed Using the EQ-5D [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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 pain as the following categories: Category 1. I am not anxious or depressed; Category 2. I am moderately anxious or depressed; Category 3.I am extremely anxious or depressed.


Enrollment: 688
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, NW1 2PG
London, United Kingdom, N18 1QX
London, United Kingdom, DD1 9SY
London, United Kingdom, NW3 2QG
London, United Kingdom, SW17 0QT
London, United Kingdom, W6 8RF
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

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
Results First Received: August 28, 2015
Last Updated: February 16, 2016
Health Authority: United Kingdom: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
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 May 05, 2016