The purpose of this open-label, single-arm, multi-center phase II trial is to evaluate the efficacy and safety of novel pan-HER inhibitor, NOV120101 (Poziotinib), as a first-line monotherapeutic agent in patients with lung adenocarcinoma harboring EGFR mutation.
Name: NOV120101 (Poziotinib)
Description: NOV120101 (Poziotinib)12 mg PO once daily until disease progression or unacceptable toxicity developmentType: DrugNOV120101 (Poziotinib)
Description: the proportion of patients with complete response (CR) and/or partial response (PR)
Measure: Objective response rate (ORR) Time: about 3 yearsDescription: the proportion of patients with complete response (CR) and/or partial response (PR) at 12 months following start of study drug administration.
Measure: Progression free survival (PFS) rate at 12 months Time: 12 months after enrollment of the last subjectDescription: the proportion of patients with CR, PR and/or stable disease (SD)
Measure: Disease control rate (DCR) Time: 3 yearsDescription: The length of time during and after medication or treatment during which the disease being treated (usually cnacer) does not get worse.
Measure: Progression free survival (PFS) Time: 3 yearsDescription: the time from study drug administration until death from any cause
Measure: Overall survival (OS) Time: 3 yearsDescription: Change means the end of treatment minus baseline in each patient
Measure: Change of quality of life (QoL) measured by EQ-5D questionnaire Time: 3 yearsDescription: to observe pharmacokinetic parameter, inter-individual variability and intra-individual variability considering covariates, demographic factors, influencing PK profile.
Measure: Population pharmacokinetics (PK) of NOV120101 (Poziotinib) Time: 3 months after enrollment of the last subjectDescription: to observe HGF expression status in plasma and T790M mutation induction status from plasma DNA
Measure: Subgroup analyses according to the genetic information Time: 3 yearsSingle Group Assignment
There are 2 SNPs
Inclusion Criteria: 1. Male or female patients aged 20 years or older 2. Pathologically confirmed stage IIIB (unresectable) or IV lung adenocarcinoma 3. Documented EGFR mutation (e.g., exon 19 deletion, exon 21 L858R, etc.) with tumor tissue 4. Patients who have 1 or more measurable lesions according to RECIST version 1.1 5. ECOG performance status 2 or less 6. --- L858R ---
Patients who cannot participate in this trial by investigator's judgment Inclusion Criteria: 1. Male or female patients aged 20 years or older 2. Pathologically confirmed stage IIIB (unresectable) or IV lung adenocarcinoma 3. Documented EGFR mutation (e.g., exon 19 deletion, exon 21 L858R, etc.) with tumor tissue 4. Patients who have 1 or more measurable lesions according to RECIST version 1.1 5. ECOG performance status 2 or less 6. --- L858R ---
to observe HGF expression status in plasma and T790M mutation induction status from plasma DNA. --- T790M ---