All-Patient General Drug Use Surveillance of Rozlytrek Capsule -ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer-

All-Patient General Drug Use Surveillance of Rozlytrek Capsule -ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer- - All-Patient General Drug Use Surveillance of Rozlytrek Capsule -ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039529

Enrollment

200

Registered

2020-02-21

Start date

2020-02-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ROS1 fusion gene-positive unresectable advanced or metastatic non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients eligible for enrollment: All patients with ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer who are planning to use Rozlytrek during the enrollment period. Patients eligible for case report form (CRF) collection: All patients eligible for enrollment who receive Rozlytrek CRFs will be collected for all patients with ROS1 fusion gene-positive unresectable advanced non-small cell lung cancer who receive Rozlytrek. Data will also be collected retrospectively from patients with ROS1 fusion gene-positive unresectable advanced non-small cell lung cancer who receive Rozlytrek before conclusion of the agreement for this surveillance study.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
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.)	—

Measure

Time frame

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.)

—

Countries

Japan

Contacts

Public ContactRyousuke Harada

Chugai Pharmaceutical Co. Ltd. Safety Science Dept.

haradarus@chugai-pharm.co.jp03-3281-6611

Outcome results