NCT00339586

Brief Summary

Current chemotherapy for advanced non-small cell lung cancer, not amenable for curative local treatment (surgery or chemoradiotherapy), has a modest life-prolonging effect and can improve quality of life. There is however no potential for long-term cure for these patients. Chemotherapy also produces variable and often significant toxicity. Current retrospective evidence suggests that significant clinical responses can be obtained when patients whose cancer cells have an EGFR TKD mutation are treated with an EGFR TKI. The ease of administration and toxicity profile of TKI compare favourably with that of chemotherapy, even single agents such as for example gemcitabine The present study will establish the clinical benefit rate of TKI as a first line treatment in patients with EGFR mutations and thus estimate the proportion of patients who might benefit for a prolonged period from a treatment with a modest toxicity profile.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
Last Updated

June 21, 2006

Status Verified

January 1, 2006

First QC Date

June 19, 2006

Last Update Submit

June 19, 2006

Conditions

Lung NeoplasmsNon-Small Cell Lung CancerAdenocarcinoma, Bronchiolo-Alveolar

Keywords

Non-small cell lung cancertyrosine kinase inhibitionfirst-line treatmentmutant EGFR-gene

Outcome Measures

Primary Outcomes (1)

  • Establish clinical benefit (progression free survival) of first line RTKI in patients with stage IV and stage IIIB NSCLC not eligible for curative-intent treatment (chemo-radiotherapy) carrying a mutant EGFR-1.

Secondary Outcomes (5)

  • Determine response rate (OR and stable disease) and duration under erlotinib treatment.

  • Determine the effect on Quality of Life (QOL) of first-line anti-EGFR-1 treatment.

  • Determine the value of positron emission tomography (PET)-scan as an early predictor of response and clinical benefit.

  • Overall survival from the time of study entry to the date of death or date of last follow-up.

  • Determine biological correlates for response/resistance in tumour tissues.

Interventions

ErlotinibDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological or cytological diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) adenocarcinoma of the lung in a patient with a smoking history of \< 15 years and quit smoking \> 1 year before diagnosis.
  • Evidence of disease but measurable disease is not mandatory.
  • years of age or older.
  • ECOG performance status of 0 - 3.
  • Patients not eligible for standard curative-intent treatment with surgery or chemo-radiotherapy.
  • Life expectancy ³ 3 months.
  • Adequate bone marrow, hepatic and renal function:
  • Granulocyte count \> 1.5 x 109/L and platelet count \> 100 x 109/L Serum bilirubin must be \< 1.5 upper limit of normal (ULN). If alkaline phosphatase is \> 2.5 x ULN, SGOT (AST) and SGPT (ALT) must be \< 1.5 x ULN.
  • Serum creatinine \< 1.5 ULN or creatinine clearance \> 60 ml/min.
  • Ability for giving informed consent for participating in the study and filling out FACT-L quality of life scales.
  • Able to comply with study and follow-up procedures.
  • Availability of tumour biopsy sample (fixed in formalin and, if possible, also snap frozen tumour sample). If frozen samples are available, these will be collected by central data management.
  • Signed Informed Consent for performing mutation analysis and subsequent biomarker analysis.
  • Separate signed Informed Consent for participation in the treatment phase of the study.
  • Ability to take oral medication.
  • +1 more criteria

You may not qualify if:

  • Patients for whom urgent chemotherapy or radiotherapy is deemed necessary (e.g. rapidly progressive disease).
  • Current symptomatic central nervous disorder, brain or leptomeningeal metastasis.
  • Pre-existing symptomatic interstitial lung disease, not related to the current malignancy.
  • Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors (small molecule or monoclonal antibody) or chemotherapy
  • Significant malabsorption syndrome or disease affecting the gastrointestinal tract function
  • Pregnant or breast-feeding women; for women in reproductive condition, a negative pregnancy test is required.
  • Concomitant food or drug intake which potentially impairs absorption and metabolisation of RTKI's.
  • Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
  • Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
  • Any significant ophthalmological abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ VUB

Jette, 1090, Belgium

RECRUITING

Related Publications (1)

  • De Greve J, Van Meerbeeck J, Vansteenkiste JF, Decoster L, Meert AP, Vuylsteke P, Focan C, Canon JL, Humblet Y, Berchem G, Colinet B, Galdermans D, Bosquee L, Vermeij J, Dewaele A, Geers C, Schallier D, Teugels E. Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT). PLoS One. 2016 Mar 31;11(3):e0147599. doi: 10.1371/journal.pone.0147599. eCollection 2016.

    PMID: 27032107DERIVED

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma, Bronchiolo-Alveolar

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinoma of LungAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jacques De Grève, MD PhD

    AZ-VUB

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques De Grève, MD PhD

CONTACT

0032 2 477 64 15jacques.degreve@az.vub.ac.be

Nicolas Fontaine, Mr

CONTACT

0032 2 477 54 61nicolas.fontaine@az.vub.ac.be

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

January 1, 2006

Last Updated

June 21, 2006

Record last verified: 2006-01

Locations

BE(1)