Monitoring the safety and effectiveness of Xalkori in lung cancer patients
XALKORI ROS1+NSCLC DRUG USE INVESTIGATION
This study is testing how safe and effective the lung cancer drug Xalkori is for patients with non-small cell lung cancer who haven't used it before.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 1 site (Tokyo) |
| Trial ID | NCT03375242 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather data on the safety and efficacy of crizotinib (Xalkori) in patients with non-small cell lung cancer (NSCLC) who have not previously been treated with this medication. The study will focus on identifying any unexpected adverse drug reactions and the overall incidence of adverse effects associated with the drug. Additionally, it will explore factors that may influence the drug's safety and effectiveness in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with unresectable progressive or recurrent NSCLC who are naive to Xalkori and have a positive ROS1 gene status.
Not a fit: Patients with a history of hypersensitivity to any ingredients of Xalkori will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety profile of Xalkori, potentially leading to improved treatment strategies for patients with ROS1-positive NSCLC.
How similar studies have performed: While this study is observational and focuses on safety, similar studies evaluating crizotinib have shown promising results in treating ROS1-positive NSCLC.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tokyo
- Pfizer local country office — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.