Clinical trial · Interventional
Retreatment With Epidermal Growth Factor Receptor(EGFR) Tyrosine Kinase Inhibitor in EGFR Mutation Positive Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Positive Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EGFR | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EGFR retreat group
- interventionNames
- Drug: EGFR
Primary outcomes (1)
- measure
- Objective Response Rate(ORR) including rage of CR&PR
- timeFrame
- Through study completion (5 years)
- description
- Assessed on based of RECIST 1.1.
Secondary outcomes (3)
- measure
- Progression Free Survival, PFS
- timeFrame
- Through study completion (5 years)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (18)
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- BACKGROUNDKinoshita FL, Ito Y, Nakayama T. Trends in Lung Cancer Incidence Rates by Histological Type in 1975-2008: A Population-Based Study in Osaka, Japan. J Epidemiol. 2016 Nov 5;26(11):579-586. doi: 10.2188/jea.JE20150257. Epub 2016 Apr 30. PMID 27150013
- BACKGROUNDDela Cruz CS, Tanoue LT, Matthay RA. Lung cancer: epidemiology, etiology, and prevention. Clin Chest Med. 2011 Dec;32(4):605-44. doi: 10.1016/j.ccm.2011.09.001. PMID 22054876
- BACKGROUNDShin A, Oh CM, Kim BW, Woo H, Won YJ, Lee JS. Lung Cancer Epidemiology in Korea. Cancer Res Treat. 2017 Jul;49(3):616-626. doi: 10.4143/crt.2016.178. Epub 2016 Sep 23. PMID 27669705
- BACKGROUNDJackman DM, Miller VA, Cioffredi LA, Yeap BY, Janne PA, Riely GJ, Ruiz MG, Giaccone G, Sequist LV, Johnson BE. Impact of epidermal growth factor receptor and KRAS mutations on clinical outcomes in previously untreated non-small cell lung cancer patients: results of an online tumor registry of clinical trials. Clin Cancer Res. 2009 Aug 15;15(16):5267-73. doi: 10.1158/1078-0432.CCR-09-0888. Epub 2009 Aug 11. PMID 19671843
- BACKGROUNDMok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.