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NCT Number: NCT02281214

NGS Genome Analysis in Personalisation of Lung Cancer Treatment

The identification of driver mutations in the epidermal growth factor receptor (EGFR) as the primary oncogenic event in a subset of lung adenocarcinomas led to a model of targeted treatment and genetic profiling of the disease. EGFR tyrosine kinase inhibitors (TKIs) confer remission in some patients, but use of the EGFR-TKIs is limited to patients with adenocarcinomas who have known activating EGFR mutations. And resistance to TKI treatment has become an increasingly important cause of treatment failure. Therefore, identification of the molecular components involved could lead to the development of effective therapy. Today only a limited number of genetic alterations are studied.

Next Generation Sequencing (NGS) has the potential of becoming an important tool in clinical and therapeutic decision-making in oncology owing to its enhanced sensitivity in DND mutation detection.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Georges François Leclerc

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients of bronchial adénocarcinoma with metastases can benefit from first-line therapy - targeted therapy by tyrosine kinase inhibitor(TKI) for EGFR mutation and chemotherapy for non EGFR mutation)
  • Patients with epidermoid cancer of the lungs can benefit from chemotherapy
  • man and women
  • age ≥ 18 years
  • Patients have signed a written informed consent form
  • Patients are affiliated to s social health insurance

Exclusion criteria

  • Survival time ≤ 3 months
  • Patients with cerebral metastases
  • Patients could not benefit from treatment for others diseases
  • Pregnancy or breast-feeding
  • Incapacity to sign the consent form for psychiatric, behavioural disorders
  • Private individuals of freedom or under tutelage

Treatment and study plan

blood sample, biopsy

Other

Blood samples and tumor biopsies will taken from patients before treatment and when tumor progression on therapy for Next Generation Sequencing (NGS) mutation analysis

Primary outcomes

  1. search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1... mutations and ALK, ROS rearrangements by NGS

    Time frame: search for EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1,... mutations and ALK , ROS rearrangements by NGS methods before treatment and when tumor progression in patients with first line metastatic lung cancer therapy (chimiotherapy, targeted therapy)

Secondary outcomes

  1. comparison of genome profiles (mutations and rearrangements)

    Time frame: comparison of genome profiles (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, ...mutations and ALK , ROS rearrangements) between targeted therapy for EGFR mutation and chemotherapy for non EGFR mutation

    To compare gene profiles (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) in primary lung tumors before treatment and when tumor progression on therapy according to treatment groups (targeted therapy for EGFR mutation and chemotherapy for non EGFR mutation) using NGS methods

  2. tumor genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) and circulating DNA genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements)

    Time frame: To compare tumor genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, AKT1, APC, ... mutations and ALK , ROS rearrangements) with circulating DNA genetic profile (EGFR, KRAS, BRAF, PIK3CA, HER2, ERBB2, ...mutations and rearrangements using NGS methods

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study title

Genome Analysis by Next Generation Sequencing in Personalisation of Lung Cancer Treatment

Acronym: ALCAPONE

Important dates

Study start
2014
Primary completion
2014
Study completion
2018
First posted
Nov 3, 2014
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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