UMIN-CTR Clinical Trial

Basic information
Public title	A multi-institutional retrospective study of dacomitinib in rechallenge setting for patients with EGFR mutation (TOPGAN2020-02)
Acronym	TOPGAN2020-02
Scientific Title	A multi-institutional retrospective study of dacomitinib in rechallenge setting for patients with EGFR mutation (TOPGAN2020-02)
Scientific Title:Acronym	TOPGAN2020-02
Region	Japan

Condition
Condition	non-small cell lung cancer(EGFR mutation +)
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the clinical coarse, the efficacy and safety, of dacomitinib for patients with EGFR mutation positive non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate the clinical coarse, the efficacy and safety, of dacomitinib for patients with EGFR mutation positive non-small cell lung cancer PFS
Key secondary outcomes	OS ORR AE

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 who received dacomitinib therapy as rechallenge setting between January 2019 and October 2020
Key exclusion criteria	None
Target sample size	40

Research contact person
Name of lead principal investigator	1st name MAKOTO Middle name Last name NISHIO
Organization	The Cancer Institute Hospital of JFCR
Division name	respiratory medicine
Zip code	135-8550
Address	31-8-3 Ariake, Koutou-ku,Tokyo
TEL	03-3520-0111
Email	ganken-net@umin.ac.jp

Public contact
Name of contact person	1st name HISASHI Middle name Tanaka Last name TANAKA
Organization	Hirosaki University garduate school of medicine
Division name	Respiratory medicine
Zip code	0368562
Address	Zaifu-cho
TEL	0172395468
Homepage URL
Email	xyghx335@gmail.com

Sponsor
Institute	TOPGAN group
Institute
Department

Funding Source
Organization	TOPGAN group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hirosaki University
Address	5, zaifu -cho, HIrosaki, Aomori, 036-8562
Tel	0172-33-5111
Email	rinri@hirosaki-u.ac.jp

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	2021 Year 01 Month 15 Day

Related information
URL releasing protocol	https://pubmed.ncbi.nlm.nih.gov/35415873/
Publication of results	Unpublished

Result
URL related to results and publications	https://pubmed.ncbi.nlm.nih.gov/35415873/
Number of participants that the trial has enrolled	40
Results	The median progression-free survival (PFS) was 4.3 months (95% confidence interval [CI], 2.5-5.6). The overall survival (OS) was 10.5 months (95% CI, 7.4-not reached).
Results date posted	2022 Year 07 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Lung cancer(EGFR posotive)
Participant flow	Patients who received dacomitinib for advanced EGFR-mutant NSCLC who had progressed after EGFR-TKI
Adverse events	diarrhea, paronychia, rash, and oral mucositis.
Outcome measures	PFS OS ORR AE
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 06 Month 01 Day
Date of IRB	2020 Year 06 Month 05 Day
Anticipated trial start date	2020 Year 06 Month 05 Day
Last follow-up date	2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective observational study

Management information
Registered date	2021 Year 01 Month 12 Day
Last modified on	2022 Year 07 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049065