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Trial record 15 of 37 for:    Recruiting, Not yet recruiting, Available Studies | Receptor tyrosine kinase

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

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ClinicalTrials.gov Identifier: NCT03382795
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical Corp.
Information provided by (Responsible Party):
Sung Yong Lee, Korea University Guro Hospital

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
EGFR Positive Non-small Cell Lung Cancer Drug: EGFR 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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
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 : January 3, 2018
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Objective Response Rate(ORR) including rage of CR&PR [ Time Frame: Through study completion (5 years) ]
    Assessed on based of RECIST 1.1.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382795


Contacts
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Contact: Sung Yong Lee, MD, Ph.D. 82-2-2626-3030 dragonett@naver.com
Contact: Youngsun Cho gomtty@daum.net

Locations
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Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang, Gyeonggi-do, Korea, Republic of, 14068
Contact: Seung Hun Jang, MD, Ph.D.         
Principal Investigator: Seung Hun Jang, MD, Ph.D.         
Pusan National University Yangsan Hospital Recruiting
Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
Contact: Seong Hoon Yoon, MD, Ph.D.         
Principal Investigator: Seong Hoon Yoon, MD, Ph.D.         
Sub-Investigator: YUN SEONG KIM, MD, Ph.D.         
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jeollanam-do, Korea, Republic of, 58128
Contact: In Jae Oh, MD, Ph.D.         
Principal Investigator: In Jae Oh, MD, Ph.D.         
Sub-Investigator: Young Chul Kim, MD, Ph.D.         
Sub-Investigator: Chul Kyu Park, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of, 35015
Contact: Jeong Eun Lee, MD, Ph.D.         
Principal Investigator: Jeong Eun Lee, MD, Ph.D.         
Sub-Investigator: Chaeuk Chung, MD, Ph.D.         
Sub-Investigator: Dong Il Park, MD         
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Eun Young Kim, MD, Ph.D.         
Principal Investigator: Eun Young Kim, MD, Ph.D.         
Sub-Investigator: Jeong Mo Lee, MD         
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 05030
Contact: Kye Young Lee, MD, Ph.D.         
Principal Investigator: Kye Young Lee, MD, Ph.D.         
Sub-Investigator: Hee Joung Kim, MD, Ph.D.         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Jae Cheol Lee, MD, Ph.D.         
Principal Investigator: Jae Cheol Lee, MD, Ph.D.         
Sub-Investigator: Chang-Min Choi, MD, Ph.D.         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 08308
Contact: Seung-hoe Song, MBE    82-2-2626-1635    ssessong@korea.ac.kr   
Principal Investigator: Sung Yong Lee, MD, Ph.D.         
Sub-Investigator: Jee Youn Oh, MD         
Sponsors and Collaborators
Korea University Guro Hospital
Chong Kun Dang Pharmaceutical Corp.
Investigators
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Principal Investigator: Sung Yong Lee, MD, Ph.D. Professor

Additional Information:
Publications:
Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Muñoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

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Responsible Party: Sung Yong Lee, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03382795     History of Changes
Other Study ID Numbers: MLCSG2017001
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sung Yong Lee, Korea University Guro Hospital:
Epidermal growth factor receptor tyrosine kinase inhibitor
Cytotoxic chemotherapy
Epidermal growth factor receptor mutation

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action