NSCLC Clinical Trial
— ALK2016CPHGOfficial 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.
| Verified date | September 2021 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
Descriptive Observational Study. Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals
| Status | Completed |
| Enrollment | 71 |
| Est. completion date | July 1, 2020 |
| Est. primary completion date | July 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Intercommunal du Pays d'Aix-Pertuis,Service de Pneumologie | Aix en Provence | |
| France | Clinique de l Europe | Amiens | |
| France | Hopital Robert Ballanger, Service de Pneumologie | Aulnay sous Bois | |
| France | Centre Hospitalier d Avignon | Avignon | |
| France | Centre Hospitalier de Beauvais | Beauvais | |
| France | Centre Hospitalier General Beziers, Service De Pneumologie | Beziers | |
| France | Centre Hospitalier de Cannes | Cannes | |
| France | Centre Hospitalier Chalon sur Saone William Morey | Chalon sur Saone | |
| France | Centre Hospitalier Metropole de Savoie-Site de Chambery | Chambery | |
| France | Hopitaux Civils de Colmar - Hopital Louis Pasteur | Colmar Cedex | |
| France | Centre Hospitalier ALPES LEMAN | Contamine sur Arve | |
| France | Centre Hospitalier Intercommunal Frejus | Frejus | |
| France | CHD Vendee | La Roche Sur Yon | |
| France | Centre Hospitalier Départemental Les Oudairies | La Roche Sur Yon Cedex 9 | |
| France | Le Mans Hospital Center | Le Mans | |
| France | Centre Hospitalier des Deux Vallees - Longjumeau BP 125 | Longjumeau | |
| France | Centre Hospitalier de Macon | Macon cedex | |
| France | Hopital Europeen - Service de Pneumologie | Marseille | |
| France | GHR Mulhouse Sud Alsace | Mulhouse | |
| France | Centre Hospitalier de l'Agglomeration de Nevers | Nevers | |
| France | Centre Hospitalier Regional d Orleans | Orleans | |
| France | Centre Hospitalier Annecy Genevois | Pringy | |
| France | Groupe Hospitalier Sud Reunion | Saint Pierre La Réunion | |
| France | Hopitaux du Leman | Thonon les Bains | |
| France | Centre Hospitalier de Troyes, Service de Pneumologie - Oncologie Thoracique | Troyes | |
| France | Centre Hospitalier de Villefranche sur Saone - BP80436 | Villefranche sur Saone |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer | French College of General Hospital Pneumologists (CPHG) |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Demographical Characteristics of Participants | Baseline up tp Month 18 | ||
| Secondary | Number of subjects using the diagnostic method used to detect ALK (Anaplastic lymphoma kinase) gene rearrangement | Baseline | ||
| Secondary | Number of Participants With Clinical Response through Month 18 | Month 3, Month 6, Month 9, Month 12, Month 15, Month 18 | ||
| Secondary | Objective Tumor Response | Baseline up to month 18 | ||
| Secondary | Progression-Free Survival (PFS) | Baseline up to Month 18 | ||
| Secondary | Number of participants with a change from baseline in (QLQ-LC 13) Quality of life Questionnaire for Lung Cancer | Baseline through Month 18 | ||
| Secondary | Change from baseline Morisky self-administered questionnaire | Baseline through month 18 | ||
| Secondary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerabitly] | Time from first dose of study drug though month 18 | ||
| Secondary | Number of subjects using diagnostic method used to detect ROS1 gene rearrangement | Baseline | ||
| Secondary | Overall Survival (OS) | Baseline , Month 12, Month 18 |
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