Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements
CLINALK
1 other identifier
observational
318
1 country
63
Brief Summary
Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2014
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 9, 2016
CompletedFirst Posted
Study publicly available on registry
April 4, 2016
CompletedMay 24, 2023
May 1, 2023
1.6 years
March 9, 2016
May 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
overall survival post-progression on crizotinib
5 years
Secondary Outcomes (1)
rare and severe complications of crizotinib therapy
5 years
Study Arms (1)
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)
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Agen - CH
Agen, 47923, France
Angers - CHU
Angers, 49033, France
Angoulême - CH
Angoulême, 16959, France
Annecy - CH
Annecy, 74374, France
Avignon - Institut Sainte-Catherine
Avignon, 84918, France
CHU Besancon - Pneumologie
Besançon, 25000, France
Bordeaux - Clinique Saint Augustin
Bordeaux, 33000, France
Boulogne - Hôpital Ambroise Paré
Boulogne, 92104, France
Brest - Hôpital du Morvan
Brest, 29200, France
CH de Cannes
Cannes, France
CH Chambery
Chambéry, France
Clermont-Ferrand - CHU
Clermont-Ferrand, 63003, France
Clermont-Ferrand - Centre Jean Perrin
Clermont-Ferrand, 63011, France
Colmar - CH
Colmar, 68000, France
CH de Dax
Dax, France
Dijon - CHU
Dijon, 63000, France
Dole - Centre Hospitalier Louis Pasteur
Dole, 39100, France
Douai - CH
Douai, 59507, France
Fréjus - CHI Saint Raphaël
Fréjus, 83608, France
Grenoble - Institut Daniel Hollard
Grenoble, 38028, France
CHRU Grenoble
Grenoble, France
Centre Hospitalier - Pneumologie
Le Havre, 76600, France
Centre Hospitalier - Pneumologie
Le Mans, 72000, France
Libourne - CH
Libourne, 35500, France
Centre Oscar Lambret
Lille, France
Limoges - Hôpital du Cluzeau
Limoges, 87042, France
Longjumeau - CH
Longjumeau, 91160, France
Marseille - Hôpital Saint Joseph
Marseille, 13285, France
Marseille - CRLCC
Marseille, France
Polyclinique du Parc
Maubeuge, France
Mâcon - CH
Mâcon, 71018, France
Meaux - CH
Meaux, 77100, France
Meulan - CHI
Meulan-en-Yvelines, 78250, France
CH de Mulhouse
Mulhouse, France
Centre Antoine Lacassagne
Nice, France
Paris - Hôpital Cochin
Paris, 75014, France
Paris - Hôpital Saint Joseph
Paris, 75014, France
Paris - Hôpital Européen Georges Pompidou
Paris, 75015, France
Hopital Tenon - Pneumologie
Paris, France
Paris - Curie
Paris, France
Pau - CH
Pau, 64046, France
Lyon Sud
Pierre-Bénite, 69495, France
CHU
Poitiers, France
Reims - Institut Courlancy
Reims, 51100, France
Rennes - Clinique Saint Laurent
Rennes, 35700, France
Rodez - CH
Rodez, 12021, France
Rouen - CHU
Rouen, 76000, France
Saint Denis de la Réunion - CHD Guyon
Saint-Denis, 97405, France
Saint Herblain - Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, 44805, France
Saint-Julien-en-Genvois - CHI
Saint-Julien-en-Genevois, 74164, France
Saint Priest en Jarez - ICL
Saint-Priest-en-Jarez, 42270, France
Strasbourg - NHC
Strasbourg, 63000, France
Strasbourg - Centre Paul Strauss
Strasbourg, 67065, France
Suresnes - Hopital Foch
Suresnes, 92151, France
Centre Hospitalier Intercommunal
Toulon, France
Toulouse - Clinique Pasteur
Toulouse, 31300, France
Toulouse - CHU Larrey
Toulouse, France
Tours - CHU
Tours, 37000, France
Troyes - CH
Troyes, 10000, France
Vannes - Centre Hospitalier Bretagne Atlantique
Vannes, 56017, France
Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud
Vénissieux, 69200, France
CH de Villefranche - Pneumologie
Villefranche, France
Villejuif - Institut Gustave Roussy
Villejuif, 94800, France
Related Publications (1)
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.
PMID: 28423535RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Denis Moro-Sibilot
Intergroupe Francophone de Cancerologie Thoracique
- PRINCIPAL INVESTIGATOR
Michael Duruisseaux
Intergroupe Francophone de Cancerologie Thoracique
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2016
First Posted
April 4, 2016
Study Start
May 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
May 24, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share