Safety and Efficacy of Xalkori ROS1

Pfizer

Status: Enrolling

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: crizotinib

Study type: Observational

Funder types: Industry

Identifiers

NCT03375242

NCT03375242 (Registry Identifier)

A8081051

Details and patient eligibility

About

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with unresectable progressive/recurrent NSCLC who are naive to XALKORI and whose tumor is ROS1 gene positive

Exclusion criteria

• Patients with past history of hypersensitivity to any of the ingredients of XALKORI

Trial design

100 participants in 1 patient group

crizotinib

Treatment:

Drug: crizotinib