Safety and Efficacy of Xalkori ROS1

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: crizotinib

• Registration Number: NCT03375242
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-25
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2026-08-24
• Study Completion: 2026-08-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
crizotinib	crizotinib	-

Primary Outcome Measures

Name	Time	Method
The incidence of adverse drug reactions in this surveillance.	52 weeks

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	12, 24, 52 weeks

Trial Locations

Locations (1)

Pfizer local country office; 🇯🇵 Tokyo, Japan