Descriptive Observational Study ALK-2016-CPHG (ALK2016CPHG)

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.

Descriptive Observational Study.

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

Study Overview

• Status: Completed
• Conditions: NSCLC; Crizotinib; ALK Gene Rearrangement or ROS1 Gene Rearrangement

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• France
  • Aix en Provence, France, 13616
    • Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie
  • Amiens, France, 80000
    • Clinique de l Europe
  • Aulnay sous Bois, France, 93 602
    • Hopital Robert Ballanger, Service de Pneumologie
  • Avignon, France, 84902
    • Centre Hospitalier d Avignon
  • Beauvais, France, 60021
    • Centre Hospitalier de Beauvais
  • Beziers, France, 34525
    • Centre Hospitalier General Beziers, Service De Pneumologie
  • Cannes, France, 06414
    • Centre Hospitalier de Cannes
  • Chalon sur Saone, France, 71321
    • Centre Hospitalier Chalon Sur Saône William Morey
  • Chambery, France, 73000
    • Centre Hospitalier Metropole de Savoie-Site de Chambery
  • Colmar Cedex, France, 68024
    • Hopitaux Civils de Colmar - Hopital Louis Pasteur
  • Contamine sur Arve, France, 74130
    • Centre Hospitalier Alpes Léman
  • Frejus, France, 83600
    • Centre Hospitalier Intercommunal Frejus
  • La Roche Sur Yon, France, 85925
    • CHD Vendee
  • La Roche Sur Yon Cedex 9, France, 85925
    • Centre Hospitalier Départemental Les Oudairies
  • Le Mans, France, 72037
    • Le Mans Hospital Center
  • Longjumeau, France, 91161
    • Centre Hospitalier des Deux Vallees - Longjumeau BP 125
  • Macon cedex, France, 71018
    • Centre Hospitalier de Mâcon
  • Marseille, France, 13003
    • Hopital Europeen - Service de Pneumologie
  • Mulhouse, France, 68051
    • Ghr Mulhouse Sud Alsace
  • Nevers, France, 58033
    • Centre Hospitalier de l'Agglomeration de Nevers
  • Orleans, France, 45000
    • Centre Hospitalier Regional d Orleans
  • Pringy, France, 74374
    • Centre Hospitalier Annecy Genevois
  • Saint Pierre La Réunion, France, 97448
    • Groupe hospitalier Sud Reunion
  • Thonon les Bains, France
    • Hopitaux du Leman
  • Troyes, France, 10003
    • Centre Hospitalier de Troyes, Service de Pneumologie - Oncologie Thoracique
  • Villefranche sur Saone, France, 69655
    • Centre Hospitalier de Villefranche sur Saone - BP80436

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Demographical Characteristics of Participants	Baseline up tp Month 18

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of subjects using the diagnostic method used to detect ALK (Anaplastic lymphoma kinase) gene rearrangement	Baseline
Number of Participants With Clinical Response through Month 18	Month 3, Month 6, Month 9, Month 12, Month 15, Month 18
Objective Tumor Response	Baseline up to month 18
Progression-Free Survival (PFS)	Baseline up to Month 18
Number of participants with a change from baseline in (QLQ-LC 13) Quality of life Questionnaire for Lung Cancer	Baseline through Month 18
Change from baseline Morisky self-administered questionnaire	Baseline through month 18
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabitly]	Time from first dose of study drug though month 18
Number of subjects using diagnostic method used to detect ROS1 gene rearrangement	Baseline
Overall Survival (OS)	Baseline , Month 12, Month 18

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: French College of General Hospital Pneumologists (CPHG)

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 24, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer (NSCLC); crizotinib; ALK gene rearrangement or ROS1 gene rearrangement
• Other Study ID Numbers: A8081060; ALK-2016-CPHG (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No