Safety and Efficacy of Xalkori ROS1

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.

Completed

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crizotinib

Drug

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. "

Other names: XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg

Primary outcomes

The incidence of adverse drug reactions in this surveillance.

Time frame: 52 weeks

Secondary outcomes

Objective Response Rate (ORR)

Time frame: 12, 24, 52 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

XALKORI ROS1+NSCLC DRUG USE INVESTIGATION

Important dates

Study start: 2017
Primary completion: 2026
Study completion: 2026
First posted: Dec 18, 2017
Registry last updated: Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed