UMIN-CTR Clinical Trial

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

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

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

Primary outcomes

Response rate

Key secondary outcomes

Progression free survival
Overall survival
Adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hokkaido Lung Cancer Clinical Study Group

Institute

Department

Personal name

Organization

Clinical Trials Core Hospitals Project

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道大学病院（北海道)

Date of disclosure of the study information

2013

Year

12

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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