Adenocarcinoma Lung Stage IV, HER2 Gene Mutation
Conditions
Keywords
pan-HER inhibitor
Brief summary
In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.
Detailed description
This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with stage IV lung adenocarcinoma with HER2 mutation who have not received prior EGFR-TKI. Approximately 47 patients will be enrolled into the trial, and expected study duration is 36 months from IRB and Korea: MFDS approval date. The study drug(poziotinib) will be administered orally as one 12 mg tablet once a day until disease progression or manifestation of unacceptable toxicity. The initial dose of the study drug 12 mg daily can be reduced to 8 mg once daily according to dose reduction criteria in protocol. A cycle of study treatment is defined as 28 days.
Interventions
DRUGPoziotinib
A cycle of study treatment is defined as 28 days.
Sponsors
Konkuk University Medical Center
Kyungpook National University Hospital
Kosin University Gospel Hospital
Chonnam National University Hospital
Chungnam National University Hospital
Korean Association for the Study of Targeted Therapy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. lung adenocarcinoma, stage IV 2. Patients with HER2 mutation by sequencing \- Confirmed triple-negative patients with remnant tumor DNA 3. Patients who have histories of previous exposure to at least one more systemic chemotherapies (not EGFR-TKI) 4. ECOG performance status 0\ 2 5. Patient with at least one measurable lesions according to RECIST 6. Patients who have proper organ functions as follows * Neutrophil count: \> 1,500/uL * Platelet count: \> 100,000/uL * Hb: \> 9.0g/dL * AST/ALT : \< 2.0 x upper normal limit * Bilirubin: \< 1.25 x upper normal limit * Serum creatinine : \< upper normal limit
Exclusion criteria
1. Expected lie expectancy \< 3 months 2. CNS metastasis or spinal cord compression which were not treated with operation and/or radiation therapy(but, Patient with medically stable condition after operation and/or radiation therapy, or without symptomatic metastasis of brain in accordance with the investigator's judgment could participate in the study) 3. Patients who have severe or unstable systemic disease in accordance with the investigator's judgment(ex, unstable or uncompensated respiratory, cardiac, hepatic or renal disease) 4. Patients who have histories of previous exposure to EGFR-TKI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate; ORR including rage of CR&PR | through study completion (3 years) | It will be assessed on based of RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression, TTP | through study completion (3 years) | from first IP administration to date of first documented progression |
Countries
South Korea
Outcome results
None listed