Clinical trial · Observational
Safety and Efficacy of Xalkori ROS1
XALKORI ROS1+NSCLC DRUG USE INVESTIGATION
NCT03375242CI-TRIAL-00124560completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| crizotinib | Drug | Crizotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- crizotinib
- interventionNames
- Drug: crizotinib
Primary outcomes (1)
- measure
- The incidence of adverse drug reactions in this surveillance.
- timeFrame
- 52 weeks
Secondary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 12, 24, 52 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.