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

July 13, 2021 updated by: Sung Yong Lee, Korea University Guro Hospital

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 35015
        • Chungnam National University Hospital
      • Seoul, Korea, Republic of, 05030
        • Konkuk University Medical Center
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Severance Hospital
    • Gyeonggi-do
      • Anyang, Gyeonggi-do, Korea, Republic of, 14068
        • Hallym University Sacred Heart Hospital
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
        • Pusan National University Yangsan Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGFR retreat group
Drug: EGFR
Gefitinib 250mg or Erlotinib 150mg medication, Once-Daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate(ORR) including rage of CR&PR
Time Frame: Through study completion (5 years)
Assessed on based of RECIST 1.1.
Through study completion (5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival, PFS
Time Frame: Through study completion (5 years)
Progression-free survival (PFS) the time from first dose of the study drug until the date of disease progression or death by any cause
Through study completion (5 years)
Overall Survival
Time Frame: Through study completion (5 years)
Overall Survival (OR) the time from first dose of the study drug until the date of death by any cause
Through study completion (5 years)
The incidence of Adverse Events(including Serious Adverse Events and Adverse Drug Reactions)
Time Frame: Through study completion (5 years)
Assessment on the base of NCI-CTCAE (version 4.03)
Through study completion (5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Collaborators

Chong Kun Dang Pharmaceutical Corp.

Investigators

  • Principal Investigator: Sung Yong Lee, MD, Ph.D., Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2018

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

December 19, 2017

First Posted (Actual)

December 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLCSG2017001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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