UMIN-CTR Clinical Trial

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
Email	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
Email	kinoshii@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido Lung Cancer Clinical Study Group
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014685