UMIN-CTR Clinical Trial

Basic information
Public title	All-Patient General Drug Use Surveillance of Rozlytrek Capsule -ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer-
Acronym	All-Patient General Drug Use Surveillance of Rozlytrek Capsule -ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer-
Scientific Title	All-Patient General Drug Use Surveillance of Rozlytrek Capsule -ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer-
Scientific Title:Acronym	All-Patient General Drug Use Surveillance of Rozlytrek Capsule -ROS1 fusion gene-positive unresectable advanced or recurrent non-small cell lung cancer-
Region	Japan

Condition
Condition	ROS1 fusion gene-positive unresectable advanced or metastatic non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The primary objectives are to evaluate the following during clinical use of Rozlytrek. 1.Type and time of onset of early symptoms of cognitive disorders (e.g., cognitive disorder, confusional state, mental status changes, memory impairment, hallucination) and ataxia 2.Action taken with Rozlytrek for and outcome of cognitive disorders (e.g., cognitive disorder, confusional state, mental status changes, memory impairment, hallucination) and ataxia 3.Incidence of cardiac disorders (excluding prolonged QT), prolonged QT, syncope, and interstitial lung disease 4.Incidence of serious adverse events not defined in the safety specification 5.Investigator-assessed response rate Safety concerns defined in the safety specification: Cognitive disorders/ataxia, cardiac disorders (excluding prolonged QT), prolonged QT, syncope, interstitial lung disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.)
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key 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.
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Nomura
Organization	Chugai Pharmaceutical Co. Ltd.
Division name	Safety Science Dept.
Zip code	1038324
Address	1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL	03-3281-6611
Email	nomuramkt@chugai-pharm.co.jp

Public contact
Name of contact person	1st name Ryousuke Middle name Last name Harada
Organization	Chugai Pharmaceutical Co. Ltd.
Division name	Real World Data Science Dept.
Zip code	1038324
Address	1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL	03-3281-6611
Homepage URL
Email	haradarus@chugai-pharm.co.jp

Sponsor
Institute	Chugai Pharmaceutical Co. Ltd.
Institute
Department

Funding Source
Organization	Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	None
Address	None
Tel	None
Email	None

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date	2020 Year 02 Month 17 Day
Last follow-up date	2023 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2022 Year 01 Month 13 Day
Last modified on	2022 Year 01 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045060

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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