Safety and Efficacy of Xalkori ROS1

XALKORI ROS1+NSCLC DRUG USE INVESTIGATION

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03375242

Enrollment

Registered

2017-12-18

Start date

2017-10-25

Completion date

2026-08-10

Last updated

2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

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.

Interventions

DRUGcrizotinib

XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg Frequency and duration are according to Package Insert as follows. " The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The incidence of adverse drug reactions in this surveillance.	52 weeks

Secondary

Measure	Time frame
Objective Response Rate (ORR)	12, 24, 52 weeks

Countries

Japan

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026