UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012551 |
|---|---|
| Receipt number | R000014685 |
| Scientific Title | A Phase II, Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Trastuzumab (Herceptin) in Patients with Her2 Overexpression/Amplification/Mutation-Positive, Pretreated, Non-Small Cell Lung Cancer (HER2-CLHERC-B/HOT1303-B) |
| Date of disclosure of the study information | 2013/12/11 |
| Last modified on | 2021/08/25 14:44:58 |
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Basic information
Public title
A Phase II, Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Trastuzumab (Herceptin) in Patients with Her2 Overexpression/Amplification/Mutation-Positive, Pretreated, Non-Small Cell Lung Cancer (HER2-CLHERC-B/HOT1303-B)
Acronym
Phase II Study of Trastuzumab for HER2-positive Non-Small Cell Lung Cancers (HER2-CLHERC-B/HOT1303-B)
Scientific Title
A Phase II, Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Trastuzumab (Herceptin) in Patients with Her2 Overexpression/Amplification/Mutation-Positive, Pretreated, Non-Small Cell Lung Cancer (HER2-CLHERC-B/HOT1303-B)
Scientific Title:Acronym
Phase II Study of Trastuzumab for HER2-positive Non-Small Cell Lung Cancers (HER2-CLHERC-B/HOT1303-B)
Region
| Japan |
Condition
Condition
Her2 overexpression/amplification/mutation-positive, pretreated, non-small cell lung cancers
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Trastuzumab in patients with Her2 overexpression/amplification/mutation-positive, pretreated, non-small cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression free survival
Overall survival
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug: Trastuzumab (Herceptin)
Trastuzumab 6 mg/kg every 3 weeks i.v. (loading dose 8 mg/kg i.v.)
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) Patients who were eligible and enrolled in "An Observational Screening Study of Overexpression/Amplification/Mutation of HER2 and its Related Molecules in Non-Small Cell Lung Cancer Patients for Personalized Medicine with Trastuzumab (HER2-CLHERC-A/HOT1303-A)" .
(See UMIN000012552 for details.)
Or patients who were eligible and enrolled in "Lung Cancer Genomic Screening Project for Individualized Medicine in Japan (LC-SCRUM-Japan)". (See UMIN000010234 for details.)
2) HER2-positive tumor that meets a) or b) of the following definition in HOT1303-A, or b) in LC-SCRUM-Japan:
a) IHC 3+, or IHC 2+ and HER2 gene amplification by dual color in situ hybridization (DISH) [HER2/CEP17 signal ratio of 2.0 or more]
b) presence of HER2 gene mutation in exon 8, 19, 20 and 21 with any relationship with trastuzumab sensitivity by preclinical or clinical studies
3) Prior chemotherapy with two or more regimens, including at least one platinum-based combination
4) One or more measurable lesion by RECIST v1.1
5) Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
6) Adequate function of main organ (bone marrow, lung, liver, renal and heart) that meets the following criteria:
a) absolute granulocyte count >= 1500/mm3
b) hemoglobin >= 9.0g/dL
c) platelet count >= 100,000/mm3
d) serum bilirubin <= 1.5 mg/dL
e) AST,ALT <= 100 IU/l
f) serum creatinine <= 1.2 mg/dL or Ccr caliculated by the Cockcroft-Gault formula >= 50ml/min
g) PaO2 (Room air) >= 60Torr (or SpO2 >= 95%)
7) Life expectancy more than 3 months
8) Written informed consent
Key exclusion criteria
1) ALK fusion positive
2) K-RAS mutation positive
3) Patients who have the following serious illness or medical condition;
a) congestive heart failure or history of documented congestive heart failure
b) angina pectoris requiring medication
c) history of myocardial infarction
d) poorly controlled hypertension (systolic >160 mmHg or diastolic >100 mmHg)
e) clinically significant valvular heart disease
f) high-risk uncontrolled arrhythmias.
4) Baseline left ventricular ejection fraction (LVEF) <50%
5) Exceeding critical dosage in prior treatment by the drug with cardiac toxicity such as anthracycline drugs
6) Interstitial pneumonitis or pulmonary fibrosis detectable on chest X-ray film or CT scan
7) Patients with dyspnoea at rest due to malignant or other disease or who require supportive oxygen therapy
8) Drug allergy career with inappropriateness for participation to this study
9) Active infectious disease that interferes to this treatment
10) Patients receiving chronic or high dose corticosteroid therapy (inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed)
11) Other serious medical complications (cerebrovascular disorder, active digestive ulcer, uncontrolled diabetes mellitus, psychological/mental illness that becomes obstacle for this study, etc)
12) HBsAg-positive; if HBcAb-positive and/or HBsAb-positive, HBV DNA-positive
13) Requirement for drainage therapy of pleural, abdominal or cardiac effusion.
14) Patients with symptomatic brain metastasis
15) Radiotherapy within 4 weeks of start of study treatment (2 week interval allowed if palliative radiotherapy given to bone metastatic site peripherally and patient recoverd from any acute toxicity)
16) Major surgery within 4 weeks of start of study treatment, without complete recovery
17) Patients with active concomitant malignancy
18) Pregnant, lactating women.
19) Inappropriate patients judged by physicians
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Akita |
Organization
Hokkaido University Hospital
Division name
Department of Medical Oncology
Zip code
Address
North 14, West 5, Kita-ku, Sapporo, 060-8648 Japan
TEL
011-706-5551
hdakita@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichiro Kinoshita |
Organization
Hokkaido University Hospital
Division name
Department of Medical Oncology
Zip code
Address
North 14, West 5, Kita-ku, Sapporo, 060-8648 Japan
TEL
011-706-5551
Homepage URL
kinoshii@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Lung Cancer Clinical Study Group
Institute
Department
Personal name
Funding Source
Organization
Clinical Trials Core Hospitals Project
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北海道大学病院（北海道)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 11 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2013 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 29 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 29 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 11 | Day |
Last modified on
| 2021 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014685
