None listed
Conditions
Interventions
Drug : Treatment group 1 ((HAD-B1 0.972g/day) : HAD-B1 650mg 2 capsules + placebo HAD-B1 650mg 2capsules, 2 times a day, before breakfast and dinner, 2capsules at a time
Treatment group 2 (HAD-B1 1.94
Sponsors
Kosin University Gospel Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 19-years-old; 2. Diagnosed with locally advanced or metastatic NSCLC who were unable to undergosurgery or radiation therapy; 3. Histologically or cytologically EGFR-positive, required afatinib therapy being failed or tolerated at least one cycle of erlotinib or gefitinib therapy; 4. With a lesion that can be measured by chest X-ray, CT or MRI with a single diameter or two diameters; 5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2; 6. Over six months life expectancy who have normal bone marrow function and solid organ function for more than 6 months; - Bone marrow: ANC = 1.5x 109/L, platelet = 10x109/L, hemoglobin = 10g/dL - Liver function: AST/ALT levels are below than 2 times of the normal upper limit - Kidney function: creatinine levels are below than 2 times of the normal upper limit 7. Voluntarily sign a written informed consent in this trial.
Exclusion criteria
Exclusion criteria: 1. Experienced severe drug hypersensitivity to a particular drug or hard to administer oral drug; 2. Currently pregnant or breastfeeding(Fertile women need adequate contraception during the study period); 3. Metastasized to the central nervous system or considered to need concurrent therapy, such as primary site radiation therapy, chemotherapy, or immunotherapy; 4. T790M (threonine-to-methionine amino acid change at position 790) of the EGFR kinase domain(acquired, rebiopsy) mutation-positive; 5. Other serious disease; (a) Uncontrollable congestive heart failure or unstable angina, myocardial infarction within 1 year of study participation, uncontrollable hypertension or high-risk arrhythmia (b) unable to understand the research content due to neurological or psychiatric disorders such as dementia and seizures (c) Uncontrollable infections such as tuberculosis and hepatitis 6. A history of diagnosis or treatment of malignant tumors other than non-small cell lung cancer; 7. Participated in the combined administration of other drug research except for afatinib and other clinical trials within 2 weeks; 8. Needed to change the cycles of chemotherapy or dosing regimens other than cisplatin or Needed to change the cycles of radiation doses during radiotherapy; 9. Needed administration of immuno-inhibitors or platinum-based chemotherapy after PD-L1 expression test with multiple metastases with symptoms; 10. Should take prohibited-medication during this clinical trial; 11. Be judged to be unsuitable for this clinical trial by researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between two dose groups (0.972 g, 1.944 g) and placebo (0 g) at the end visit (visit 4, medication 12th week) | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison between the two dose groups (0.972 g, 1.944 g) and the placebo group (0 g) at the visit 2(6 weeks) and end visit 4 ( 12 weeks) for evaluation of DCR(CR, PR, SD, PFS, TTP);Comparison between the two dose groups (0.972 g, 1.944 g) and the placebo group (0 g) at the visit 2(6 weeks) and end visit 4 ( 12 weeks) for evaluation of anemia and neutropenia(absolute neutrophil counts);Comparison between the two dose groups (0.972 g, 1.944 g) and the placebo group (0 g) at the visit 2(6 weeks) and end visit 4 ( 12 weeks) for evaluation of QOL and anti-fatigue questionnaire(EORTC QLQ-C30) | — |
Countries
Korea, Republic of
Contacts
Public ContactHwa-Seung Yoo
Dunsan Korean Medicine Hospital of Daejeon University
Outcome results
None listed