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)

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) - An Observational Study of Abnormalities of HER2 and its Related Molecules in Non-Small Cell Lung Cancers (HER2-CLHERC-A/HOT1303-A)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000012552

Enrollment

200

Registered

2013-12-11

Start date

2013-12-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 years and over at the time of consent 2) Histologically confirmed diagnosis of non-small cell lung cancer 3) EGFR mutation negative 4) Patients who meets either of the following criteria: i) unresectable locally advanced or metastatic disease ii) post-operative recurrent disease iii) progressive disease after radical radiation therapy 5) Patients who plan to receive first line chemotherapy or who undergo or complete first or subsequent lines of chemotherapy 6) Formalin-fixed paraffin embedded (FFPE) samples containing NSCLC tissue are available 7) Written informed consent

Exclusion criteria

Exclusion criteria: Alk fusion-positive patients who underwent ALK testing. (Patients who have not undergone ALK testing are eligible.)

Design outcomes

Primary

Measure	Time frame
Frequency of overexpression, amplification and mutation of HER2 in non-small cell lung cancer	—

Secondary

Measure	Time frame
1) Frequency of overexpression, amplification and mutation of HER2 related molecules including driver genes in non-small cell lung cancer 2) Correlation between HER2 and its related molecules 3) Correlation between their abnormalities and clinical and clincopathological features	—

Countries

Japan

Contacts

Public ContactIchiro Kinoshita

Hokkaido University Hospital Department of Medical Oncology

kinoshii@med.hokudai.ac.jp011-706-5551

Outcome results