Safety and Efficacy of Xalkori ROS1

Last updated: February 12, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Treatment

crizotinib

Clinical Study ID

NCT03375242
A8081051
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: crizotinib
Phase:
Study Start date:
October 25, 2017
Estimated Completion Date:
August 24, 2026

Connect with a study center

  • Pfizer local country office

    Tokyo,
    Japan

    Active - Recruiting

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