UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035622 |
|---|---|
| Receipt number | 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 | 2022/01/24 09:11:42 |
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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
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
okamotoi@kokyu.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
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
ishida-e@med.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
JapicCTI-194620
Org. issuing International ID_1
Japic Clinical Trials Information
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
22
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 12 | Month | 24 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2021 | Year | 05 | Month | 24 | Day |
Date trial data considered complete
| 2021 | Year | 06 | Month | 03 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 22 | Day |
Last modified on
| 2022 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040516
