Status:
UNKNOWN
Retreatment With Epidermal Growth Factor Receptor(EGFR) Tyrosine Kinase Inhibitor in EGFR Mutation Positive Patients
Lead Sponsor:
Korea University Guro Hospital
Collaborating Sponsors:
Chong Kun Dang Pharmaceutical Corp.
Conditions:
EGFR Positive Non-small Cell Lung Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
In this trial, treatment efficacy and safety of retreatment with 1st generation epidermal growth factor receptor(EGFR) tyrosine kinase inhibitor(TKI)s(Gefitinib/Erlotinib), will be assessed in patient...
Detailed Description
This study is designed to be multi-center, open-label, single-arm, prospective, phase II trial of patient with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients who previously tr...
Eligibility Criteria
Inclusion
- Males or females ≥ 19 years of age
- Non Small Cell Lung Cancer(Non-Squamous Cell Carcinoma) patients who had shown clinical benefits (Complete response(CR) or Partial response(PR) or Stable disease(SD) ≥6 months) from EGFR-TKIs as first line treatment and developed progressive disease, and then received cytotoxic chemotherapy more than 4 cycles and developed progressive disease, and then confirmed T790 negative and sensitizing EGFR mutation(E19Del, L858R, L861Q, G719X, E19insertion) positive in Histologic, cytologic specimen or blood.
- Patient with at least one measurable lesions according to RECIST v 1.1
- Expected life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group(ECOG) performance status ≤ 2
- Patients who have proper hematologic, renal and hepatic functions as follows:
- Absolute neutrophil count(ANC) ≥ 1,500/mm³
- platelets ≥ 100,000/mm³
- Hemoglobin ≥ 9g/dL
- Total bilirubin ≤ 1.25 X UNL
- Aspartate aminotransferase(AST or SGOT) and alanine aminotransferase(ALT or SGPT) ≤ 3.0 X UNL (if liver metastasis ≤5.0 X UNL)
- Alkaline phosphatase ≤ 2.5 X UNL (if liver metastasis ≤5.0 X UNL)
- Serum creatinine ≤ 1.5mg/dL
- patients who are willing to comply with study procedure and voluntarily provide informed consent with signature
Exclusion
- Patients who have preexisting or coexisting malignancies in other parts except for effectively treated non-melanoma skin cancer, cervical carcinoma in situ(CIS) cervical cancer within the last 5 years
- Patients with brain metastasis except for the followings:
- \- Asymptomatic and stable brain metastases for which local treatment has been given: corticosteroids treatment isn't requiured for at least 2 weeks before starting the study treatment.
- Patients currently receiving palliative radiation therapy or have toxicities from radiation therapy at screening.
- Patients with clinically active history of interstitial lung disease(ILD), Drug induced ILD, Radiation pneumonitis
- Patients with clinically significant cardiovascular disease or myocardial infarction within the past 12 months.
- Patients with active infection or severe systemic disease that are difficult to include in this study
- Patients who received radiation therapy to target lesion of this study.
- Patients who had major operation within 4 weeks before starting the study treatment and were not fully recovered.
- Patients who were administered other study drugs within 4 weeks before starting the study treatment
- Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive pregnancy test prior to study entry
- Patients who are difficult to include in this study in accordance with the investigator's judgment
- Patients with histories of hypersensitivity to investigational product(IP) or any components of the agent
- Patients with any of the following genetic predispositions including galactose intolerance, Lapp lactase deficiency, lactose intolerance or glucose-galactose malabsorption
- Patient previously received cytotoxic chemotherapy within 2 weeks of IP administration
- Patient received Immunotherapy prior to the study participation
- Patients who are difficult to include in this study in accordance with the investigator's judgment due to severe adverse effects during previous EGFR TKI treatment
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03382795
Start Date
January 3 2018
End Date
March 31 2023
Last Update
July 15 2021
Active Locations (8)
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1
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea, 14068
2
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
3
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea, 58128
4
Chungnam National University Hospital
Daejeon, South Korea, 35015