Retreatment With Epidermal Growth Factor Receptor(EGFR) Tyrosine Kinase Inhibitor in EGFR Mutation Positive Patients

NCT03382795 | Unknown Phase 2

• 1 other identifier: MLCSG2017001
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 8

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 patients with sensitizing EGFR mutation positive Non-Squamous Cell Carcinoma patients who previously treated with EGFR TKI and cytotoxic chemotherapy

Conditions

EGFR Positive Non-small Cell Lung Cancer

Keywords

Epidermal growth factor receptor tyrosine kinase inhibitor; Cytotoxic chemotherapy; Epidermal growth factor receptor mutation

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR) including rage of CR&PR

  Assessed on based of RECIST 1.1.

  Through study completion (5 years)

Secondary Outcomes (3)

• Progression Free Survival, PFS

  Through study completion (5 years)

• Overall Survival

  Through study completion (5 years)

• The incidence of Adverse Events(including Serious Adverse Events and Adverse Drug Reactions)

  Through study completion (5 years)

Study Arms (1)

EGFR retreat group

EXPERIMENTAL

Drug: EGFR

Interventions

EGFR DRUG

Gefitinib 250mg or Erlotinib 150mg medication, Once-Daily.

EGFR retreat group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Chong Kun Dang Pharmaceutical Corp.: collaborator

Study Sites (8)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, 50612, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Yonsei University Severance Hospital

Seoul, 03722, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

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Related Links

• GLOBOCAN 2012: estimated cancer incidence, mortality and prevalence worldwide in 2012. All cancers (excluding nonmelanoma skin cancer) estimated incidence, mortality and prevalence worldwide in 2012 \[Internet\]. Geneva: World Health Organization

Study Officials

• Sung Yong Lee, MD, Ph.D.

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: January 3, 2018
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

KR (8)