Her2 overexpression/amplification/mutation-positive, pretreated, non-small cell lung cancers
Conditions
Interventions
Drug: Trastuzumab (Herceptin) Trastuzumab 6 mg/kg every 3 weeks i.v. (loading dose 8 mg/kg i.v.)
Sponsors
Hokkaido Lung Cancer Clinical Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Overall survival Adverse events | — |
Countries
Japan
Contacts
Public ContactIchiro Kinoshita
Hokkaido University Hospital Department of Medical Oncology
Outcome results
None listed