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Trial record 1 of 1 for:    NCT03718117
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Descriptive Observational Study ALK-2016-CPHG (ALK2016CPHG)

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ClinicalTrials.gov Identifier: NCT03718117
Recruitment Status : Active, not recruiting
First Posted : October 24, 2018
Last Update Posted : May 31, 2019
Sponsor:
Collaborator:
French College of General Hospital Pneumologists (CPHG)
Information provided by (Responsible Party):
Pfizer

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


Condition or disease
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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
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.
Actual Study Start Date : January 3, 2017
Estimated Primary Completion Date : December 6, 2019
Estimated Study Completion Date : December 6, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib




Primary Outcome Measures :
  1. Demographical Characteristics of Participants [ Time Frame: Baseline up tp Month 18 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718117


Locations
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France
Centre Hospitalier Intercommunal Aix-Pertuis, Site d'Aix en Provence, Service De Pneumologie
Aix en Provence, France, 13616
Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie
Aix en Provence, France, 13616
Clinique de l Europe
Amiens, France, 80000
Hopital Robert Ballanger, Service de Pneumologie
Aulnay sous Bois, France, 93 602
Centre Hospitalier d Avignon
Avignon, France, 84902
Centre Hospitalier De La Cote Basque
Bayonne, France, 64109
Centre Hospitalier de Beauvais
Beauvais, France, 60021
Centre Hospitalier General Beziers, Service De Pneumologie
Beziers, France, 34525
Centre Hospitalier De Cahors - CHG Jean Rougier
Cahors, France, 46005
Centre Hospitalier de Cannes
Cannes, France, 06414
Centre Hospitalier Chalon sur Saone William Morey
Chalon sur Saone, France, 71321
Centre Hospitalier Metropole de Savoie-Site de Chambery
Chambery, France, 73000
Hopitaux Civils de Colmar - Hopital Louis Pasteur
Colmar Cedex, France, 68024
Centre Hospitalier Alpes Leman
Contamine sur Arve, France, 74130
Centre Hospitalier Intercommunal Frejus
Frejus, France, 83600
CHD Vendee, Service De Pneumologie
La Roche Sue Yon, France, 85925
Centre Hospitalier Départemental Les Oudairies
La Roche Sur Yon Cedex 9, France, 85925
CHD Vendee
La Roche Sur Yon, France, 85925
Le Mans Hospital Center
Le Mans, France, 72037
Centre Hospitalier De Libourne - Hopital Robert Boulin
Libourne, France, 33505
Centre Hospitalier des Deux Vallees - Longjumeau BP 125
Longjumeau, France, 91161
Centre Hospitalier de Macon
Macon cedex, France, 71018
Centre hospitalier Francois Quesnay - Mantes la Jolie
Mantes la Jolie, France, 78201
Hopital Europeen - Service de Pneumologie
Marseille, France, 13003
Centre Hospitalier de Meaux
Meaux, France, 77104
GHR Mulhouse Sud Alsace
Mulhouse, France, 68051
Centre Hospitalier de l'Agglomeration de Nevers
Nevers, France, 58033
Centre Hospitalier Regional d Orleans
Orleans, France, 45000
Groupe Hospitalier Paris Saint Joseph
Paris, France, 75014
Centre Hospitalier Annecy Genevois
Pringy, France, 74374
Centre Hospitalier Int. Elbeuf Louviers Val De Reuil, Service De Pneumologie
Saint Aubin les Elbeuf, France, 76503
Groupe Hospitalier Sud Reunion
Saint Pierre La Réunion, France, 97448
Hopitaux du Leman
Thonon les Bains, France
Centre Hospitalier de Troyes, Service de Pneumologie - Oncologie Thoracique
Troyes, France, 10003
Centre Hospitalier de Villefranche sur Saone - BP80436
Villefranche sur Saone, France, 69655
Sponsors and Collaborators
Pfizer
French College of General Hospital Pneumologists (CPHG)
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03718117     History of Changes
Other Study ID Numbers: A8081060
ALK-2016-CPHG ( Other Identifier: Alias Study Number )
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Non-Small Cell Lung Cancer (NSCLC)
crizotinib
ALK gene rearrangement or ROS1 gene rearrangement

Additional relevant MeSH terms:
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Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action