None listed
Conditions
Interventions
Drug : * Treatment Group:
HAD-B1 645mg 2 capsules, 2 times a day(1 capsule at a time) before breakfast and dinner + Afatinib 1 capsule/day
* Control Group:
Afatinib 1 capsule/day, Dose(20~40mg) can
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with non-small cell lung cancer histologically including mixed-histology of the locally advanced or metastatic stage. (Stage IIIA or higher by TNM 8th Edition) 2. A patient with EGFR-positive who requires primary treatment of Afatinib judged by the investigator 3. A patient with measurable diseases by RECIST 1.1 4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 5. A person who can take the drug orally at the judgment of the investigator 6. Over 19 years old 7. Sufficiently understand and voluntarily agree and sign in written consent form after hearing the explanation of this clinical trial
Exclusion criteria
Exclusion criteria: 1. T790M(acquired, re-biopsy) gene Positive 2. Active brain metastasis patients (stable for <4 weeks, patients with symptoms or meningeal disease). Dexamethasone treatment may be acceptable if a stable dose is administered for at least 4 weeks. 3. Those with severe gastrointestinal disorders with severe or uncontrolled diarrhea within 2 weeks of screening as the main symptom. (For example, Crohn's disease, malabsorption, or etiological diarrhea of CTC-grade 2 or higher based on the investigator's assessment.) 4. Determined that registration is difficult by the investigator due to existing interstitial lung disease 5. Severe hepatic impairment patient (Child Pugh C) 6. Severe renal impairment (eGFR <15 mL/min) or on dialysis 7. Clinically significant cardiovascular disease (NYHA category 3 congestive heart failure, unstable angina or uncontrolled arrhythmia, angina, myocardial infarction within 1 year, etc.) 8. Women of childbearing potential who do not use appropriate contraceptive methods before the start of the study 9. Maternal breastfeeding or pregnant 10. Suspected or known to have a serious mental illness such as drug abuse or alcoholism. 11. Hypersensitivity reaction to Afatinib or EGFR products. 12. Hypersensitivity to HAD-B1 and its component ingredients 13. Persons who participated in other clinical trials within 1 month of screening. 14. Those who do not comply with this clinical trial, including serious infectious diseases or organ dysfunction at the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Starting dose maintenance rate for afatinib;Disease Control Rate (DCR) according to RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) according to RECIST 1.1;Time to Progression (TTP);Overall survival rate (OS);Objective Response Rate(ORR) ;Tumor size reduction;Health-related Quality of Life;Tumor marker;Exploratory study between cold-heat pattern identification between congenital genotypes and/or treatment responses;Frequency and severity, pattern of Events of Special Interest (ESI);Overall safety profile;Treatment discontinuation rate and reasons, Dose reduction rate of Afatinib | — |
Countries
Korea, Republic of
Contacts
Public ContactMi Jung Jeon
Daejeon University
Outcome results
None listed