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

Sponsor
Korea University Guro Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03382795
Collaborator
Chong Kun Dang Pharmaceutical Corp. (Industry)
63
8
1
62.9
7.9
0.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
63 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 3, 2018
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: EGFR retreat group

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

Outcome Measures

Primary Outcome Measures

  1. Objective Response Rate(ORR) including rage of CR&PR [Through study completion (5 years)]

    Assessed on based of RECIST 1.1.

Secondary Outcome Measures

  1. Progression Free Survival, PFS [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

  2. Overall Survival [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

  3. The incidence of Adverse Events(including Serious Adverse Events and Adverse Drug Reactions) [Through study completion (5 years)]

    Assessment on the base of NCI-CTCAE (version 4.03)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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.
  1. Patients currently receiving palliative radiation therapy or have toxicities from radiation therapy at screening.

  2. Patients with clinically active history of interstitial lung disease(ILD), Drug induced ILD, Radiation pneumonitis

  3. Patients with clinically significant cardiovascular disease or myocardial infarction within the past 12 months.

  4. Patients with active infection or severe systemic disease that are difficult to include in this study

  5. Patients who received radiation therapy to target lesion of this study.

  6. Patients who had major operation within 4 weeks before starting the study treatment and were not fully recovered.

  7. Patients who were administered other study drugs within 4 weeks before starting the study treatment

  8. 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

  9. Patients who are difficult to include in this study in accordance with the investigator's judgment

  10. Patients with histories of hypersensitivity to investigational product(IP) or any components of the agent

  11. Patients with any of the following genetic predispositions including galactose intolerance, Lapp lactase deficiency, lactose intolerance or glucose-galactose malabsorption

  12. Patient previously received cytotoxic chemotherapy within 2 weeks of IP administration

  13. Patient received Immunotherapy prior to the study participation

  14. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hallym University Sacred Heart Hospital Anyang Gyeonggi-do Korea, Republic of 14068
2 Pusan National University Yangsan Hospital Yangsan Gyeongsangnam-do Korea, Republic of 50612
3 Chonnam National University Hwasun Hospital Hwasun Jeollanam-do Korea, Republic of 58128
4 Chungnam National University Hospital Daejeon Korea, Republic of 35015
5 Yonsei University Severance Hospital Seoul Korea, Republic of 03722
6 Konkuk University Medical Center Seoul Korea, Republic of 05030
7 Asan Medical Center Seoul Korea, Republic of 05505
8 Korea University Guro Hospital Seoul Korea, Republic of 08308

Sponsors and Collaborators

  • Korea University Guro Hospital
  • Chong Kun Dang Pharmaceutical Corp.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Sung Yong Lee, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier:
NCT03382795
Other Study ID Numbers:
  • MLCSG2017001
First Posted:
Dec 26, 2017
Last Update Posted:
Jul 15, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sung Yong Lee, Professor, Korea University Guro Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2021