Descriptive Observational Study ALK-2016-CPHG (ALK2016CPHG)

Pfizer

Status: Completed

Conditions: Crizotinib; ALK Gene Rearrangement or ROS1 Gene Rearrangement; NSCLC

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03718117

ALK-2016-CPHG (Other Identifier)

A8081060

Details and patient eligibility

About

Descriptive Observational Study.

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

Full description

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

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design