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Non-small Cell Lung CancerCLINALKNCT02727335

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

An observational study of Non-small Cell Lung Cancer and Anaplastic Lymphoma Kinase Gene Mutation, run by Intergroupe Francophone de Cancerologie Thoracique at 63 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib Read more about this study

Who is it for?
Ages 18 years and older
How many people
318 participants
Where
63 sitesFrance
Study dates
May 2014to Dec 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

63 sites in 1 country.

63 sites in 1 country

France63 sites

  • Agen - CH

    Agen, 47923

  • Angers - CHU

    Angers, 49033

  • Angoulême - CH

    Angoulême, 16959

  • Annecy - CH

    Annecy, 74374

  • Avignon - Institut Sainte-Catherine

    Avignon, 84918

  • CHU Besancon - Pneumologie

    Besançon, 25000

  • Bordeaux - Clinique Saint Augustin

    Bordeaux, 33000

  • Boulogne - Hôpital Ambroise Paré

    Boulogne, 92104

  • Brest - Hôpital du Morvan

    Brest, 29200

  • CH de Cannes

    Cannes

  • CH Chambery

    Chambéry

  • Clermont-Ferrand - CHU

    Clermont-Ferrand, 63003

  • Clermont-Ferrand - Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Colmar - CH

    Colmar, 68000

  • CH de Dax

    Dax

  • Dijon - CHU

    Dijon, 63000

  • Dole - Centre Hospitalier Louis Pasteur

    Dole, 39100

  • Douai - CH

    Douai, 59507

  • Fréjus - CHI Saint Raphaël

    Fréjus, 83608

  • Grenoble - Institut Daniel Hollard

    Grenoble, 38028

  • CHRU Grenoble

    Grenoble

  • Centre Hospitalier - Pneumologie

    Le Havre, 76600

  • Centre Hospitalier - Pneumologie

    Le Mans, 72000

  • Libourne - CH

    Libourne, 35500

  • Centre Oscar Lambret

    Lille

  • Limoges - Hôpital du Cluzeau

    Limoges, 87042

  • Longjumeau - CH

    Longjumeau, 91160

  • Mâcon - CH

    Mâcon, 71018

  • Marseille - Hôpital Saint Joseph

    Marseille, 13285

  • Marseille - CRLCC

    Marseille

  • Polyclinique du Parc

    Maubeuge

  • Meaux - CH

    Meaux, 77100

  • Meulan - CHI

    Meulan-en-Yvelines, 78250

  • CH de Mulhouse

    Mulhouse

  • Centre Antoine Lacassagne

    Nice

  • Paris - Hôpital Cochin

    Paris, 75014

  • Paris - Hôpital Saint Joseph

    Paris, 75014

  • Paris - Hôpital Européen Georges Pompidou

    Paris, 75015

  • Hopital Tenon - Pneumologie

    Paris

  • Paris - Curie

    Paris

  • Pau - CH

    Pau, 64046

  • Lyon Sud

    Pierre-Bénite, 69495

  • CHU

    Poitiers

  • Reims - Institut Courlancy

    Reims, 51100

  • Rennes - Clinique Saint Laurent

    Rennes, 35700

  • Rodez - CH

    Rodez, 12021

  • Rouen - CHU

    Rouen, 76000

  • Saint Denis de la Réunion - CHD Guyon

    Saint-Denis, 97405

  • Saint Herblain - Institut de Cancérologie de l'Ouest - René Gauducheau

    Saint-Herblain, 44805

  • Saint-Julien-en-Genvois - CHI

    Saint-Julien-en-Genevois, 74164

  • Saint Priest en Jarez - ICL

    Saint-Priest-en-Jarez, 42270

  • Strasbourg - NHC

    Strasbourg, 63000

  • Strasbourg - Centre Paul Strauss

    Strasbourg, 67065

  • Suresnes - Hopital Foch

    Suresnes, 92151

  • Centre Hospitalier Intercommunal

    Toulon

  • Toulouse - Clinique Pasteur

    Toulouse, 31300

  • Toulouse - CHU Larrey

    Toulouse

  • Tours - CHU

    Tours, 37000

  • Troyes - CH

    Troyes, 10000

  • Vannes - Centre Hospitalier Bretagne Atlantique

    Vannes, 56017

  • Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud

    Vénissieux, 69200

  • CH de Villefranche - Pneumologie

    Villefranche

  • Villejuif - Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

Read the 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.

Keywords
Non-squamous non-small cell lung cancer, crizotinib, real-world study, IFCT
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02727335
Study groupRoleWhat they receive
patients ALK + who received crizotinibpatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    overall survival post-progression on crizotinib

    Measured: 5 years

Secondary outcomes (1)

  1. rare and severe complications of crizotinib therapy

    Incidence of rare and severe complications of crizotinib therapy: hepatotoxicity, interstitial pneumonitis, diastolic heart failure

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2016 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02727335
Sponsor's protocol ID
IFCT-1302
Acronym
CLINALK
Status last verified
May 2023
First submitted
9 Mar 2016
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Duruisseaux M, Besse B, Cadranel J, Perol M, Mennecier B, Bigay-Game L, Descourt R, Dansin E, Audigier-Valette C, Moreau L, Hureaux J, Veillon R, Otto J, Madroszyk-Flandin A, Cortot A, Guichard F, Boudou-Rouquette P, Langlais A, Missy P, Morin F, Moro-Sibilot D. Overall survival with crizotinib and next-generation ALK inhibitors in ALK-positive non-small-cell lung cancer (IFCT-1302 CLINALK): a French nationwide cohort retrospective study. Oncotarget. 2017 Mar 28;8(13):21903-21917. doi: 10.18632/oncotarget.15746.

    PubMed 28423535

Questions about this trial

What is this clinical trial studying?

An observational study of Non-small Cell Lung Cancer and Anaplastic Lymphoma Kinase Gene Mutation, run by Intergroupe Francophone de Cancerologie Thoracique at 63 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02727335, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.

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