Advanced non-small cell lung cancer positive for HER2 exon 20 insertion mutation
Conditions
Interventions
Intravenous administration of T-DM1 (3.6 mg/kg) on day1 q21 days until discontinuation of the protocol unless any of the discontinuation criteria of protocol treatment is applicable.
Sponsors
Kyushu University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Confirmed histologically or cytologically as NSCLC 2.Clinical stage III or IV or postoperative recurrent NSCLC 3.Positive for HER2 exon 20 insertion 4.Tissue samples of FFPE (5 micrometer x 10 slices) are thought to be available with consent of the patient 5.Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2 6.Treatment history of chemotherapy within 1 or 2 regimens. Single use of immune-checkpoint inhibitors or adjuvant chemotherapy which passed over 24 weeks (168 days) from the last administration are not included in the count of regimen. Combination use of immune-checkpoint inhibitors and chemotherapy is deemed as 1 regimen 7. Aged 20 years or older at the time of informed consent 8.Harboring one or more measurable disease assessed by RECIST v1.1 9.Without SVC syndrome, pericardial effusion, pleural effusion or ascites with Grade 3 or more (CTCAE v5.0) 10. LVEF >= 50% assessed by echocardiogram within 28 days 11. Sufficient time has passed from the previous treatment a) operation with general anesthesia: 2 weeks b) biopsy with incision and treatment for injury: 2 weeks c) palliative radiotherapy for metastasis: 2 weeks (gamma knife or SRS for brain metastasis: 1 week) 12. All of the following criteria are met based on the latest data obtained within 14 days before enrollment 1)Neutrophil count >= 1,500/microliter 2)Hemoglobin >= 9.0 g/dL 3)Platelet count >= 10X10^4/ microliter 4)Total bilirubin <= 1.5 x ULN 5)AST <= 2.5 x ULN 6)ALT <= 2.5 x ULN 7)Serum creatinine <= 1.5 x ULN 8)PT and APTT <= 1.5 x ULN 9) SpO2 >= 92% at room air. Patients with SpO2 < 92% are eligible if PaO2 is >= 60 torr. 10)Provided written informed consent
Exclusion criteria
Exclusion criteria: 1.Patients with an infection requiring systemic treatment 2.Patients with treatment history of HER2 inhibitors 3.History of hypersensitivity of grade 3 or more to additive substance (sodium succinate, sucrose, polysorbate 20) of that of severe hypersensitivity to other drugs 4.Patients with clinically significant psychiatric disease or symptom that would interfere with participation in this study. 5.With driver mutation other than HER2 mutation (EGFR activating mutation, ALK fusion gene, ROS1 fusion gene, BRAF V600E, RET fusion gene, MET exon 14 skip mutation, NTRK fusion gene) 6.Patients with symptomatic brain metastases 7.Patients with carcinomatous meningitis 8.Patients with active double cancer 9.Patients with poorly controlled hypertension or diabetes mellitus 10.Patients with clinically meaningful heart diseases including 1)New York Heart Association(NYHA)class II or more or heart disorder with Grade 3 or more assessed by CTCAE v5.0 2)Patients with congestive heart failure or medication-needed ventricular arrythmia within 6 months 11.Patients with clinically meaningful coronary artery disease (unstable angina, myocardial infarct) within 6 months 12. Patients with positive for hepatitis B surface (HBs) antigen or positive hepatitis C virus (HCV) antibody 13. Patients with distinct interstitial pneumonitis or pulmonary fibrosis based on chest CT 14. Pregnant or lactating females. Females of child-bearing potential with the positive result of the urine pregnancy test that was carried out within 14 days before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate: RR | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival: PFS Overall Survival: OS Duration of Response: DoR Percentage of patients with at least 1 adverse event | — |
Countries
Japan
Contacts
Public ContactIsamu Okamoto
Kyushu University Hospital Research Institute for Diseases of the Chest
Outcome results
None listed