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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035622
Receipt No. R000040516
Scientific Title A Multicenter Phase II study of Trastuzumab emtansine for non-small cell lung cancer positive for HER2 exon 20 insertion mutation.
Date of disclosure of the study information 2019/01/22
Last modified on 2019/08/22

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Basic information
Public title A Multicenter Phase II study of Trastuzumab emtansine for non-small cell lung cancer positive for HER2 exon 20 insertion mutation.
Acronym PRECISION trial
Scientific Title A Multicenter Phase II study of Trastuzumab emtansine for non-small cell lung cancer positive for HER2 exon 20 insertion mutation.
Scientific Title:Acronym PRECISION trial
Region
Japan

Condition
Condition Advanced non-small cell lung cancer positive for HER2 exon 20 insertion mutation
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy and safety in the treatment of trastuzumab emtansine (T-DM1) for advanced non-small cell lung cancer positive for HER2 exon 20 insertion mutation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate: RR
Key secondary outcomes Progression-free survival: PFS
Overall Survival: OS
Duration of Response: DoR
Percentage of patients with at least 1 adverse event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous administration of T-DM1 (3.6 mg/kg) on day1 q21 days until discontinuation of the protocol unless any of the discontinuation criteria of protocol treatment is applicable.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Confirmed histologically or cytologically as NSCLC
2.Clinical stage III or IV or postoperative recurrent NSCLC
3.Positive for HER2 exon 20 insertion
4.Tissue samples of FFPE (5 micrometer x 10 slices) are thought to be available with consent of the patient
5.Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2
6.Treatment history of chemotherapy within 1 or 2 regimens. Single use of immune-checkpoint inhibitors or adjuvant chemotherapy which passed over 24 weeks (168 days) from the last administration are not included in the count of regimen. Combination use of immune-checkpoint inhibitors and chemotherapy is deemed as 1 regimen
7. Aged 20 years or older at the time of informed consent
8.Harboring one or more measurable disease assessed by RECIST v1.1
9.Without SVC syndrome, pericardial effusion, pleural effusion or ascites with Grade 3 or more (CTCAE v5.0)
10. LVEF >= 50% assessed by echocardiogram within 28 days
11. Sufficient time has passed from the previous treatment
a) operation with general anesthesia: 2 weeks
b) biopsy with incision and treatment for injury: 2 weeks
c) palliative radiotherapy for metastasis: 2 weeks
(gamma knife or SRS for brain metastasis: 1 week)
12. All of the following criteria are met based on the latest data obtained within 14 days before enrollment
1)Neutrophil count >= 1,500/microliter
2)Hemoglobin >= 9.0 g/dL
3)Platelet count >= 10X10^4/ microliter
4)Total bilirubin <= 1.5 x ULN
5)AST <= 2.5 x ULN
6)ALT <= 2.5 x ULN
7)Serum creatinine <= 1.5 x ULN
8)PT and APTT <= 1.5 x ULN
9) SpO2 >= 92% at room air. Patients with SpO2 < 92% are eligible if PaO2 is >= 60 torr.
10)Provided written informed consent
Key exclusion criteria 1.Patients with an infection requiring systemic treatment
2.Patients with treatment history of HER2 inhibitors
3.History of hypersensitivity of grade 3 or more to additive substance (sodium succinate, sucrose, polysorbate 20) of that of severe hypersensitivity to other drugs
4.Patients with clinically significant psychiatric disease or symptom that would interfere with participation in this study.
5.With driver mutation other than HER2 mutation (EGFR activating mutation, ALK fusion gene, ROS1 fusion gene, BRAF V600E, RET fusion gene, MET exon 14 skip mutation, NTRK fusion gene)
6.Patients with symptomatic brain metastases
7.Patients with carcinomatous meningitis
8.Patients with active double cancer
9.Patients with poorly controlled hypertension or diabetes mellitus
10.Patients with clinically meaningful heart diseases including
1)New York Heart Association(NYHA)class II or more or heart disorder with Grade 3 or more assessed by CTCAE v5.0
2)Patients with congestive heart failure or medication-needed ventricular arrythmia within 6 months
11.Patients with clinically meaningful coronary artery disease (unstable angina, myocardial infarct) within 6 months
12. Patients with positive for hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody
13. Patients with distinct interstitial pneumonitis or pulmonary fibrosis based on chest CT
14. Pregnant or lactating females. Females of child-bearing potential with the positive result of the urine pregnancy test that was carried out within 14 days before enrollment
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Isamu
Middle name
Last name Okamoto
Organization Kyushu University Hospital
Division name Research Institute for Diseases of the Chest
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5378
Email okamotoi@kokyu.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Isamu
Middle name
Last name Okamoto
Organization Kyushu University Hospital
Division name Research Institute for Diseases of the Chest
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
TEL 092-642-5378
Homepage URL
Email okamotoi@kokyu.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development:AMED
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Kyushu University Institutional Review Board
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
Tel 092-642-5774
Email ishida.eik@iberica.co.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 九州大学病院(福岡県)       Kyushu University Hospital
大阪市立総合医療センター(大阪府) Osaka City General Hospital
鳥取大学医学部附属病院(鳥取県)     Tottori University Hospital
名古屋大学医学部附属病院(愛知県)    Nagoya University Hospital
がん研究会有明病院(東京都)       Cancer Institute Hospital
仙台厚生病院(宮城県) Sendai Kousei Hospital
国立がん研究センター 東病院(千葉県)  National Cancer Center Hospital East
静岡県立静岡がんセンター(静岡県)    Shizuoka Cancer Center

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 22 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 27 Day
Date of IRB
2019 Year 01 Month 07 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 01 Month 22 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040516

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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