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Pharmacogenomic Study Realized Within the Framework of the Common Care to "Non-small Cell Lung Carcinoma" at Any Stages Treated by Chemotherapy.

18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

Pharmacogenomic Study Realized Within the Framework of the Common Care to "Non-small Cell Lung Carcinoma" at Any Stages Treated by Chemotherapy.

Lung carcinoma will be the fifth death cause in the world in 2020. In Europe it causes more
deaths than carcinoma of breast, colon and prostate combined so it is a public healthcare
priority. Applying high throughput molecular analysis technologies to pharmacogenomics could
improve lung carcinoma care strategies. The study hypothesis is that the determination of
the genomic and proteomic profiles of non-small cell lung carcinoma patients will allow
treatment targeting , improving treatment efficacy and tolerance.

In order to carry out this study, the five thoracic oncology centers of the Rhône-Alpes
region will collaborate with several INSERM (French national research institute) units and
new biotechnology companies.

The primary objective of this study is to correlate molecular genetic profile with response
to chemotherapy in cases of primary chemotherapy treatment for non-small cell lung

Biological samples will be collected before and during patient care to correlate clinical
evolution (response and tolerance) with:

- circulating cell polymorphism profile

- proteomic profile

- genetic and epigenetic modifications of genes involved in DNA repair, drugs metabolism,
apoptosis cell regulation mechanisms, and cell mobility and adhesion mechanisms.

The main judgment criteria will be response to chemotherapy correlated with patient's
biological profile.

Second judgment criteria will be overall survival and hematology toxicity which will be
evaluated each new cycle of chemotherapy.

The second purpose of this study is to validate less invasive methods of sampling using
blood, expectoration, urine, fixed biopsies and lungs tapping, as a substitute to the
current reference (frozen tumor), which is out of reach in clinical examination.

This will contribute to setting of a multicentric resources bank, to define targets for new
drugs and to develop oligoarrays allowing adapted chemotherapies.

Two previous studies (1800 and 500 patients respectively) have already been carried out,
data and samples are available.

For this study, 600 patients will be included over 3 years.

Inclusion Criteria:

- Patient older than 18 suffering from Non-Small-Cell Lung Carcinoma

- Patient treated by chemotherapy with platinum salt

- Every stage TNM classification

- No previous chemotherapy

- One measurable lesion out of nervous central system at least

- Performance status from 0 to 2 on ECOG scale

- Life expectancy > 12 weeks

Exclusion Criteria:

- Previous or Concomitant carcinoma over 5 last years

- Concomitant radiotherapy

- Cardiac disease

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Chritian Brambilla, Pr.

Investigator Role:

Study Director

Investigator Affiliation:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

DCIC 04 40



Start Date:

July 2005

Completion Date:

August 2010

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Non-Small-Cell Lung
  • Pharmacogenomic
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms