All-Patient General Drug Use Surveillance of Rozlytrek Capsule -ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer
Not Applicable
Recruiting
- Conditions
- ROS1 fusion gene-positive unresectable advanced or metastatic non-small cell lung cancer
- Registration Number
- JPRN-UMIN000039529
- Lead Sponsor
- Chugai Pharmaceutical Co. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
None
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety 1.Incidence of early symptoms of cognitive disorders or ataxia by type 2.Time of onset of early symptoms of cognitive disorders or ataxia (e.g., basic statistics) 3.Proportion of patients requiring action with respect to Rozlytrek (e.g., treatment interruption, treatment discontinuation) at onset of cognitive disorder or ataxia 4.Outcome rate (e.g., recovered, improved) by action taken with Rozlytrek (treatment interruption, treatment discontinuation) at onset of cognitive disorder or ataxia 5.Incidence of ADRs by type (by MedDRA PT, by safety concern defined in the safety specification) Effectiveness: 1.Investigator-assessed response rate (Assess response using RECIST.) 2.Investigator-assessed response rate in patients with ROS1 fusion gene mutations (Assess response using RECIST.)
- Secondary Outcome Measures
Name Time Method