Status:

RECRUITING

Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC

Lead Sponsor:

Groupe Francais De Pneumo-Cancerologie

Collaborating Sponsors:

Takeda

Conditions:

Non-small Cell Lung Cancer

ALK Gene Rearrangement Positive

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort ...

Detailed Description

BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with new generation TKIs in first line, included in the national EXPLORE ALK cohort (...

Eligibility Criteria

Inclusion Criteria:

  • Stage IIIB/IV NSCLC non eligible to locoregional treatment with curative intent
  • ALK rearrangement confirmed by IHC and/or FISH or NGS according to local methods
  • Patient included in the EXPLORE ALK study
  • Age > or = 18 years
  • Patient treated with first-line new generation ALKi
  • Patient agrees to sign an informed consent form and to collect blood samples at inclusion, first tumor evaluation and progression and for whom tumor biopsy at diagnosis is available
  • Patient enrolled in the french National Health Insurance program or with a third- party payer

Exclusion Criteria:

  • Patients who do not wish to participate in Bioexalk
  • Patients under guardianship

Key Trial Info

Start Date :

September 22 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2027

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT05122806

Start Date

September 22 2021

End Date

June 30 2027

Last Update

August 6 2025

Active Locations (46)

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Page 1 of 12 (46 locations)

1

Pneumologie CHU Félix Guyon

Saint-Denis, La Réunion, France, 97400

2

Centre Hospitalier d'Aix en Provence

Aix-en-Provence, France, 13616

3

Pneumologie CHU

Amiens, France, 80054

4

Centre Hospitalier Universitaire

Angers, France, 49033

Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC | DecenTrialz