Clinical trial NCT03718117: Descriptive Observational Study ALK-2016-CPHG
Official title: CHARACTERISTICS OF ADULT PATIENTS TREATED WITH CRIZOTINIB FOR ADVANCED NON-SMALL-CELL LUNG CANCER (NSCLC) WITH ALK GENE REARRANGEMENT OR ROS1 GENE REARRANGEMENT IN GENERAL HOSPITALS.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC
Crizotinib
ALK Gene Rearrangement or ROS1 Gene Rearrangement
Keywords: Non-Small Cell Lung Cancer (NSCLC)
crizotinib
ALK gene rearrangement or ROS1 gene rearrangement
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: French College of General Hospital Pneumologists (CPHG)
First posted: 2018-10-24
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with ALK positive or ROS1-positive Locally advanced or metastatic non-small cell lung cancer NSCLC, initiated in the previous 3 months or participants initiating crizotinib treatment regardless of the line of treatment

Brief summary: Descriptive Observational Study.

Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals

Detailed description: Describe the characteristics of patients treated with crizotinib Describe efficacy, safety, observance and QoL.

Eligibility criteria: Inclusion criteria

* Age ≥ 18 years
* Locally advanced or metastatic NSCLC
* Patient ALK gene rearrangement or ROS1 gene rearrangement
* Patient having initiated in the previous 3 months or patient initiating crizotinib treatment regardless of the line of treatment
* Patient followed up by a physician in a hospital pulmonary medicine department
* Subject of reproductive age, using an effective method of contraception
* Patient informed verbally and in writing on the study and having consented to his/her personal data being collected within the scope of the study.

Non-inclusion criteria

* Patient included within the scope of an interventional therapeutic trial
* Patient not presenting with ALK gene rearrangement or ROS1 gene rearrangement
* Patient not available for follow-up throughout the duration of the study
* Patient deemed to be incapable of responding to the study questions for linguistic, cognitive or organisational reasons.

Primary outcomes:
measure: Age: Line of Treatment
timeFrame: Baseline
measure: Body Weight: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Body Mass Index (BMI): Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Gender: Line of Treatment
timeFrame: Baseline
measure: Number of Participants Classified According to Smoking Status at Baseline: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Pack Years: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Duration of Smoking and Duration of Quitting Smoke: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Assessment: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to ECOG Performance Status Scores: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Time Since Diagnosis of NSCLC: Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to Type of Tumor's Histology: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to Tumor Stage: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to Tumor Location: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to Presence of Metastases: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to Number of Metastatic Sites: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to Location of Metastases: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Time Since the First Strategy Start to Crizotinib Initiation: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized as "Yes" or "No" for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Cycles for Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Duration of Different Lines of Previous Chemotherapy: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized as "Yes" or "No" for Previous Brain Irradiation Therapy, Previous Radiotherapies and Previous Tyrosine Kinase Inhibitor Therapy: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Dose of Previous Brain Irradiation and Radiotherapies: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Duration of Previous Brain Irradiation Therapy and Radiotherapies: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
Secondary outcomes:
measure: Number of Participants Categorized According to Diagnostic Method to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to Origin of Specimen to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to Analysis Platform to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to Technique Used to Detect ALK and ROS1 Gene Rearrangement: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Duration Between Sending and Receipt of ALK and ROS1 Results: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Among Whom Search for Other Biological Markers Was Carried Out: Line of Treatment and Gene Rearrangement
timeFrame: Baseline
measure: Number of Participants Categorized According to Clinical Response at Month 3, 6, 9, 12, 15 and 18
timeFrame: Month 3, 6, 9, 12, 15 and 18
measure: Number of Participants Categorized According to Tumor Response at Month 3, 6, 9, 12, 15 and 18
timeFrame: Month 3, 6, 9, 12, 15 and 18
measure: Time Since Diagnosis to Progression at Month 3, 6, 9, 12, 15 and 18
timeFrame: Month 3, 6, 9, 12, 15 and 18
measure: Number of Participants With Site of Progression as Primary Tumor at Month 3, 6, 9, 12, 15 and 18
timeFrame: Month 3, 6, 9, 12, 15 and 18
measure: Number of Participants With Site of Progression as Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18
timeFrame: Month 3, 6, 9, 12, 15 and 18
measure: Number of Participants Categorized According to Location of Progression in Already Existing Metastasis at Month 3, 6, 9, 12, 15 and 18
timeFrame: Month 3, 6, 9, 12, 15 and 18
measure: Number of Participants With Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18
timeFrame: Month 3, 6, 9, 12, 15 and 18
measure: Number of Participants Categorized According to Location of Site of Progression as New Metastases at Month 3, 6, 9, 12, 15 and 18
timeFrame: Month 3, 6, 9, 12, 15 and 18
measure: Treatment Duration Until Progression With Brain Metastases
timeFrame: Baseline
measure: Number of Participants With Biopsy on Progression at Month 3, 6, 9, 12, 15 and 18
timeFrame: Month 3, 6, 9, 12, 15 and 18
measure: Objective Response Rate (ORR)
timeFrame: Maximum up to 18 months
measure: Disease Control Rate (DCR) at Month 12 and 18
timeFrame: Month 12, 18
measure: European Organization for Research and Treatment of Cancer (EORTC) Lung Cancer (LC) Module 13 Symptom Scales Scores at Baseline, Month 3, 6, 9, 12, 15 and 18
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18
measure: Time to Median Progression Free Survival (Months) With Its 95%CI
timeFrame: 18 months
measure: 18-Month Overall Survival (OS) Rate (95%CI)
timeFrame: 18 months
measure: Number of Participants Per Morisky Score Classification at Month 3, 6, 9, 12, 15 and 18
timeFrame: Month 3, 6, 9, 12, 15 and 18
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to maximum of 18 months
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie
city: Amiens
country: France
facility: Clinique de l Europe
city: Aulnay sous Bois
country: France
facility: Hopital Robert Ballanger, Service de Pneumologie
city: Avignon
country: France
facility: Centre Hospitalier d Avignon
city: Beauvais
country: France
facility: Centre Hospitalier de Beauvais
city: Beziers
country: France
facility: Centre Hospitalier General Beziers, Service De Pneumologie
city: Cannes
country: France
facility: Centre Hospitalier de Cannes
city: Chalon sur Saone
country: France
facility: Centre Hospitalier Chalon sur Saone William Morey
city: Chambery
country: France
facility: Centre Hospitalier Metropole de Savoie-Site de Chambery
city: Colmar Cedex
country: France
facility: Hopitaux Civils de Colmar - Hopital Louis Pasteur
city: Contamine sur Arve
country: France
facility: Centre Hospitalier ALPES LEMAN
city: Frejus
country: France
facility: Centre Hospitalier Intercommunal Frejus
city: La Roche Sur Yon Cedex 9
country: France
facility: Centre Hospitalier Départemental Les Oudairies
city: La Roche Sur Yon
country: France
facility: CHD Vendee
city: Le Mans
country: France
facility: Le Mans Hospital Center
city: Longjumeau
country: France
facility: Centre Hospitalier des Deux Vallees - Longjumeau BP 125
city: Macon cedex
country: France
facility: Centre Hospitalier de Macon
city: Marseille
country: France
facility: Hopital Europeen - Service de Pneumologie
city: Mulhouse
country: France
facility: GHR Mulhouse Sud Alsace
city: Nevers
country: France
facility: Centre Hospitalier de l'Agglomeration de Nevers
city: Orleans
country: France
facility: Centre Hospitalier Regional d Orleans
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois
city: Saint Pierre La Réunion
country: France
facility: Groupe Hospitalier Sud Reunion
city: Thonon les Bains
country: France
facility: Hopitaux du Leman
city: Troyes
country: France
facility: Centre Hospitalier de Troyes, Service de Pneumologie - Oncologie Thoracique
city: Villefranche sur Saone
country: France
facility: Centre Hospitalier de Villefranche sur Saone - BP80436
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: