Description:
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 patients with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma
patients who previously treated with EGFR TKI and cytotoxic chemotherapy
Title
- Brief Title: Retreatment With Epidermal Growth Factor Receptor(EGFR) Tyrosine Kinase Inhibitor in EGFR Mutation Positive Patients
- Official Title: Retreatment With 1st Generation EGFR TKIs in Sensitizing EGFR Mutation Positive Non-Squamous Cell Carcinoma Patients Who Previously Treated With EGFR TKI and Cytotoxic Chemotherapy
Clinical Trial IDs
- ORG STUDY ID:
MLCSG2017001
- NCT ID:
NCT03382795
Conditions
- EGFR Positive Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
EGFR | | EGFR retreat group |
Purpose
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 patients with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma
patients who previously treated with EGFR TKI and cytotoxic chemotherapy
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 treated with EGFR TKI and cytotoxic chemotherapy. Approximately 69 patients
will be enrolled into the trial, and expected study duration is 48 months from Institutional
Review Board(IRB) and Korea Ministry of Food and Drug Safety(MFDS) approval date.
The study drug will be administered orally as one tablet(Gefitinib 250mg/ Erlotinib 150mg)
once a day until disease progression or manifestation of unacceptable toxicity. The initial
dose of the study drug daily can be reduced according to dose reduction criteria in protocol.
A cycle of study treatment is defined as 28 days, and subjects will visit the site every 2
cycles(56 days).
Trial Arms
Name | Type | Description | Interventions |
---|
EGFR retreat group | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
1. Males or females ≥ 19 years of age
2. 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.
3. Patient with at least one measurable lesions according to RECIST v 1.1
4. Expected life expectancy ≥ 12 weeks
5. Eastern Cooperative Oncology Group(ECOG) performance status ≤ 2
6. 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
7. patients who are willing to comply with study procedure and voluntarily provide
informed consent with signature
Exclusion Criteria:
1. 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
2. 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.
3. Patients currently receiving palliative radiation therapy or have toxicities from
radiation therapy at screening.
4. Patients with clinically active history of interstitial lung disease(ILD), Drug
induced ILD, Radiation pneumonitis
5. Patients with clinically significant cardiovascular disease or myocardial infarction
within the past 12 months.
6. Patients with active infection or severe systemic disease that are difficult to
include in this study
7. Patients who received radiation therapy to target lesion of this study.
8. Patients who had major operation within 4 weeks before starting the study treatment
and were not fully recovered.
9. Patients who were administered other study drugs within 4 weeks before starting the
study treatment
10. 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
11. Patients who are difficult to include in this study in accordance with the
investigator's judgment
12. Patients with histories of hypersensitivity to investigational product(IP) or any
components of the agent
13. Patients with any of the following genetic predispositions including galactose
intolerance, Lapp lactase deficiency, lactose intolerance or glucose-galactose
malabsorption
14. Patient previously received cytotoxic chemotherapy within 2 weeks of IP administration
15. Patient received Immunotherapy prior to the study participation
16. 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 19 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective Response Rate(ORR) including rage of CR&PR |
Time Frame: | Through study completion (5 years) |
Safety Issue: | |
Description: | Assessed on based of RECIST 1.1. |
Secondary Outcome Measures
Measure: | Progression Free Survival, PFS |
Time Frame: | Through study completion (5 years) |
Safety Issue: | |
Description: | Progression-free survival (PFS) the time from first dose of the study drug until the date of disease progression or death by any cause |
Measure: | Overall Survival |
Time Frame: | Through study completion (5 years) |
Safety Issue: | |
Description: | Overall Survival (OR) the time from first dose of the study drug until the date of death by any cause |
Measure: | The incidence of Adverse Events(including Serious Adverse Events and Adverse Drug Reactions) |
Time Frame: | Through study completion (5 years) |
Safety Issue: | |
Description: | Assessment on the base of NCI-CTCAE (version 4.03) |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Korea University Guro Hospital |
Trial Keywords
- Epidermal growth factor receptor tyrosine kinase inhibitor
- Cytotoxic chemotherapy
- Epidermal growth factor receptor mutation
Last Updated
July 15, 2021