Clinical trial · Interventional
Poziotinib in Stage IV Lung Adenocarcinoma With HER2 Mutation (KASTT001)
A Phase II Study to Assess Efficacy of Pan-HER Inhibitor (HM781-36B, Poziotinib) in Stage IV Lung Adenocarcinoma With HER2 Mutation
NCT02979821CI-TRIAL-00033083completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this trial, treatment efficacy and safety of Poziotinib will be assessed in patients with stage IV lung adenocarcinoma harboring HER2 mutation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma Lung Stage IV | Lung Adenocarcinoma | PROBABILISTIC | 0.70 |
| HER2 Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Poziotinib | Drug | Poziotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Poziotinib
- description
- 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.
- interventionNames
- Drug: Poziotinib
Primary outcomes (1)
- measure
- Objective Response Rate; ORR including rage of CR&PR
- timeFrame
- through study completion (3 years)
- description
- It will be assessed on based of RECIST 1.1.
Secondary outcomes (1)
- measure
- Time to progression, TTP
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.