Clinical trial NCT02727335: Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements
Official title: Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer
Anaplastic Lymphoma Kinase Gene Mutation
Keywords: Non-squamous non-small cell lung cancer
crizotinib
real-world study
IFCT
Lead sponsor: Intergroupe Francophone de Cancerologie Thoracique
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: rare and severe complications of crizotinib therapy
timeFrame: 5 years
Other outcomes:
Locations:
city: Agen
country: France
facility: Agen - CH
city: Angers
country: France
facility: Angers - CHU
city: Angoulême
country: France
facility: Angoulême - CH
city: Annecy
country: France
facility: Annecy - CH
city: Avignon
country: France
facility: Avignon - Institut Sainte-Catherine
city: Besancon
country: France
facility: CHU Besancon - Pneumologie
city: Bordeaux
country: France
facility: Bordeaux - Clinique Saint Augustin
city: Boulogne
country: France
facility: Boulogne - Hôpital Ambroise Paré
city: Brest
country: France
facility: Brest - Hôpital du Morvan
city: Cannes
country: France
facility: CH de Cannes
city: Chambery
country: France
facility: CH Chambery
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand - CHU
city: Clermont-Ferrand
country: France
facility: Clermont-Ferrand - Centre Jean Perrin
city: Colmar
country: France
facility: Colmar - CH
city: Dax
country: France
facility: CH de Dax
city: Dijon
country: France
facility: Dijon - CHU
city: Dole
country: France
facility: Dole - Centre Hospitalier Louis Pasteur
city: Douai
country: France
facility: Douai - CH
city: Fréjus
country: France
facility: Fréjus - CHI Saint Raphaël
city: Grenoble
country: France
facility: Grenoble - Institut Daniel Hollard
city: Grenoble
country: France
facility: CHRU Grenoble
city: Le Havre
country: France
facility: Centre Hospitalier - Pneumologie
city: Le Mans
country: France
facility: Centre Hospitalier - Pneumologie
city: Libourne
country: France
facility: Libourne - CH
city: Lille
country: France
facility: Centre Oscar Lambret
city: Limoges
country: France
facility: Limoges - Hôpital du Cluzeau
city: Longjumeau
country: France
facility: Longjumeau - CH
city: Marseille
country: France
facility: Marseille - Hôpital Saint Joseph
city: Marseille
country: France
facility: Marseille - CRLCC
city: Maubeuge
country: France
facility: Polyclinique du Parc
city: Meaux
country: France
facility: Meaux - CH
city: Meulan-en-Yvelines
country: France
facility: Meulan - CHI
city: Mulhouse
country: France
facility: CH de Mulhouse
city: Mâcon
country: France
facility: Mâcon - CH
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Paris - Hôpital Cochin
city: Paris
country: France
facility: Paris - Hôpital Saint Joseph
city: Paris
country: France
facility: Paris - Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hopital Tenon - Pneumologie
city: Paris
country: France
facility: Paris - Curie
city: Pau
country: France
facility: Pau - CH
city: Pierre Bénite
country: France
facility: Lyon Sud
city: Poitiers
country: France
facility: CHU
city: Reims
country: France
facility: Reims - Institut Courlancy
city: Rennes
country: France
facility: Rennes - Clinique Saint Laurent
city: Rodez
country: France
facility: Rodez - CH
city: Rouen
country: France
facility: Rouen - CHU
city: Saint Herblain
country: France
facility: Saint Herblain - Institut de Cancérologie de l'Ouest - René Gauducheau
city: Saint Priest en Jarez
country: France
facility: Saint Priest en Jarez - ICL
city: Saint-Denis
country: France
facility: Saint Denis de la Réunion - CHD Guyon
city: Saint-Julien-en-Genevois
country: France
facility: Saint-Julien-en-Genvois - CHI
city: Strasbourg
country: France
facility: Strasbourg - NHC
city: Strasbourg
country: France
facility: Strasbourg - Centre Paul Strauss
city: Suresnes
country: France
facility: Suresnes - Hopital Foch
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal
city: Toulouse
country: France
facility: Toulouse - Clinique Pasteur
city: Toulouse
country: France
facility: Toulouse - CHU Larrey
city: Tours
country: France
facility: Tours - CHU
city: Troyes
country: France
facility: Troyes - CH
city: Vannes
country: France
facility: Vannes - Centre Hospitalier Bretagne Atlantique
city: Villefranche
country: France
facility: CH de Villefranche - Pneumologie
city: Villejuif
country: France
facility: Villejuif - Institut Gustave Roussy
city: Vénissieux
country: France
facility: Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud
Study officials:
affiliation: Intergroupe Francophone de Cancerologie Thoracique
name: Denis Moro-Sibilot
role: PRINCIPAL_INVESTIGATOR
affiliation: Intergroupe Francophone de Cancerologie Thoracique
name: Michael Duruisseaux
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.