Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements (CLINALK)

May 23, 2023 updated by: Intergroupe Francophone de Cancerologie Thoracique
Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

Study Overview

Status

Completed

Conditions

Detailed Description

Several French studies on crizotinib have been conducted in recent years. These are not only patients treated in the PROFILE 1005 and 1007 clinical studies but also patients who have been treated with crizotinib in the named patient ATU followed by the cohort ATU (Expended Access Cohort). Under the ATU program and according to ATU regulations, a limited set of data is collected and furthermore the follow up is stopped as soon as the ATU program closes. Thus it is not possible to have access to long term data and post progression data. Our project is to collect data from the patients from the ATU program (named patient and cohort) and if possible patients treated after the marketing of crizotinib, before, during and after crizotinib therapy. Centers selected for this observational study will be those of the IFCT network that took part in the ATU program.

This will allow an accurate analysis of crizotinib therapy under "real life" conditions. It should be emphasized that this information is generally neither available from clinical trials nor from ATU programs.

Study Type

Observational

Enrollment (Actual)

318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Agen, France, 47923
        • Agen - CH
      • Angers, France, 49033
        • Angers - CHU
      • Angoulême, France, 16959
        • Angoulême - CH
      • Annecy, France, 74374
        • Annecy - CH
      • Avignon, France, 84918
        • Avignon - Institut Sainte-Catherine
      • Besancon, France, 25000
        • CHU Besancon - Pneumologie
      • Bordeaux, France, 33000
        • Bordeaux - Clinique Saint Augustin
      • Boulogne, France, 92104
        • Boulogne - Hôpital Ambroise Paré
      • Brest, France, 29200
        • Brest - Hôpital du Morvan
      • Cannes, France
        • CH de Cannes
      • Chambery, France
        • CH Chambery
      • Clermont-Ferrand, France, 63003
        • Clermont-Ferrand - CHU
      • Clermont-Ferrand, France, 63011
        • Clermont-Ferrand - Centre Jean Perrin
      • Colmar, France, 68000
        • Colmar - CH
      • Dax, France
        • CH de Dax
      • Dijon, France, 63000
        • Dijon - CHU
      • Dole, France, 39100
        • Dole - Centre Hospitalier Louis Pasteur
      • Douai, France, 59507
        • Douai - CH
      • Fréjus, France, 83608
        • Fréjus - CHI Saint Raphaël
      • Grenoble, France
        • CHRU Grenoble
      • Grenoble, France, 38028
        • Grenoble - Institut Daniel Hollard
      • Le Havre, France, 76600
        • Centre Hospitalier - Pneumologie
      • Le Mans, France, 72000
        • Centre Hospitalier - Pneumologie
      • Libourne, France, 35500
        • Libourne - CH
      • Lille, France
        • Centre Oscar Lambret
      • Limoges, France, 87042
        • Limoges - Hôpital du Cluzeau
      • Longjumeau, France, 91160
        • Longjumeau - CH
      • Marseille, France
        • Marseille - CRLCC
      • Marseille, France, 13285
        • Marseille - Hôpital Saint Joseph
      • Maubeuge, France
        • Polyclinique du Parc
      • Meaux, France, 77100
        • Meaux - CH
      • Meulan-en-Yvelines, France, 78250
        • Meulan - CHI
      • Mulhouse, France
        • CH de Mulhouse
      • Mâcon, France, 71018
        • Mâcon - CH
      • Nice, France
        • Centre Antoine Lacassagne
      • Paris, France
        • Paris - Curie
      • Paris, France, 75014
        • Paris - Hôpital Cochin
      • Paris, France, 75014
        • Paris - Hôpital Saint Joseph
      • Paris, France, 75015
        • Paris - Hôpital Européen Georges Pompidou
      • Paris, France
        • Hopital Tenon - Pneumologie
      • Pau, France, 64046
        • Pau - CH
      • Pierre Bénite, France, 69495
        • Lyon Sud
      • Poitiers, France
        • CHU
      • Reims, France, 51100
        • Reims - Institut Courlancy
      • Rennes, France, 35700
        • Rennes - Clinique Saint Laurent
      • Rodez, France, 12021
        • Rodez - CH
      • Rouen, France, 76000
        • Rouen - CHU
      • Saint Herblain, France, 44805
        • Saint Herblain - Institut de Cancérologie de l'Ouest - René Gauducheau
      • Saint Priest en Jarez, France, 42270
        • Saint Priest en Jarez - ICL
      • Saint-Denis, France, 97405
        • Saint Denis de la Réunion - CHD Guyon
      • Saint-Julien-en-Genevois, France, 74164
        • Saint-Julien-en-Genvois - CHI
      • Strasbourg, France, 63000
        • Strasbourg - NHC
      • Strasbourg, France, 67065
        • Strasbourg - Centre Paul Strauss
      • Suresnes, France, 92151
        • Suresnes - Hopital Foch
      • Toulon, France
        • Centre Hospitalier Intercommunal
      • Toulouse, France
        • Toulouse - CHU Larrey
      • Toulouse, France, 31300
        • Toulouse - Clinique Pasteur
      • Tours, France, 37000
        • Tours - CHU
      • Troyes, France, 10000
        • Troyes - CH
      • Vannes, France, 56017
        • Vannes - Centre Hospitalier Bretagne Atlantique
      • Villefranche, France
        • CH de Villefranche - Pneumologie
      • Villejuif, France, 94800
        • Villejuif - Institut Gustave Roussy
      • Vénissieux, France, 69200
        • Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with NSCLC carrying the ALK rearrangement in the named patient or cohort crizotinib ATU. This will be supplemented, where possible, by the patients with crizotinib prescriptions under the Marketing Authorisation.

Description

Inclusion Criteria:

  • Patient must have locally advanced or metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK determined by IHC and/or FISH.
  • Patient who received crizotinib on an expanded access basis (compassionate use) (ATU) due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable
  • Patient who received marketed crizotinib as a result of the standard care of metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK will also be eligible.
  • Patient was able to swallow capsules and had no surgical or anatomical condition that precluded the patient from swallowing and absorbing oral medications on an ongoing basis.
  • Patient has taken at least 1 week of treatment

Exclusion Criteria:

  • Patient included in a crizotinib clinical trial
  • Patient with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients ALK + who received crizotinib
patients with ALK rearrangement who started treatment with crizotinib (250 mg twice a day) between the 18/11/2010 and the 31/12/2013 (will include patients from the ATU programs and patients treated after the marketing of crizotinib)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years
overall survival post-progression on crizotinib
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rare and severe complications of crizotinib therapy
Time Frame: 5 years
Incidence of rare and severe complications of crizotinib therapy: hepatotoxicity, interstitial pneumonitis, diastolic heart failure
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intergroupe Francophone de Cancerologie Thoracique

Investigators

  • Principal Investigator: Denis Moro-Sibilot, Intergroupe Francophone de Cancerologie Thoracique
  • Principal Investigator: Michael Duruisseaux, Intergroupe Francophone de Cancerologie Thoracique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IFCT-1302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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