KCT0003376招募中未知
A Phase II Pilot, Single arm, Open label, Multi-center Study of Gefitinib as Sequential Therapy in Patients with Locally Advanced non-Small Cell Lung Cancer (Stage III) with Sensitizing EGFR Mutations who have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •1.Males or females = 19 years of age
- •2.Stage III, NSCLC patient with histological or cytological confirmation of sensitizing EGFR mutation(E19Del, L858R, L861Q, G719X)[according to edition 8 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology]
- •3.Non-Squamous Lung Cancer patients who received of platinum-based, Concurrent Chemoradiation Therapy
- •4.Patient who has completed the previous routine treatment(CCRT) within 14 to 42 days prior to first dose of investigational product in the study.
- •As routine practice
- •?The platinum-based chemotherapy regimen must contain one of the following agents: etoposide, a taxane (paclitaxel or docetaxel), vinblastine, vinorelbine or pemetrexed
- •?Following radiation therapy after starting chemotherapy in CCRT according to the site condition is permitted. But consolidation except for Durvalumab after CCRT is not permitted.
- •?Where possible, chemotherapy regimens should be given according to National Comprehensive Cancer Network (NCCN) Guidelines or European Society for Medical Oncology (ESMO) Guidelines.
- •?Recommended to have received a total dose of radiation of 60Gy±10%(54Gy-66Gy) in CCRT, but 45Gy±10% (40Gy-50Gy) in case of patient with previous operation for Lung cancer treatment. Sites are encouraged to adhere to mean organ radiation dosing as follows:
- •?Mean lung dose must be <20 Gy and/or V20 must be <35%
- •?Mean esophagus dose must be <34 Gy
- •?Heart V45 <35% or V30 <30%.
- •In case of unresectable, patients who have not progressed 90 days after completion of Durvalumab treatment after platinum-based, concurrent chemoradiotherapy could be enrolled in the study.
- •However, patients who have not progressed 90 days after completion of Durvalumab treatment could be enrolled if Durvalumab treatment has been discontinued due to patient refusal or side effects.
- •5.Patients must have not progressed following platinum-based, concurrent chemoradiation therapy(more than stable disease according to RECIST v1.1)
- •6.Expected life expectancy = 12 weeks
- •7.Eastern Cooperative Oncology Group(ECOG) performance status = 2
- •8.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 = 2 X UNL
- •?AST(SGOT), ALT(SGPT) = 3.0 X UNL
- •?Alkaline phosphatase = 2.5 X UNL
- •?Creatinine clearance = 20ml/min by Cockcroft-Gault formula
- •9.Patients who are willing to comply with study procedure and provide informed consent with signature prior to any study procedure
排除标准
- •1.Patients who have preexisting or coexisting malignancies in other parts within the last 5 years except non-melanoma skin cancer, CIS cervical cancer, gastric cancer, thyroid cancer, breast cancer and colon cancer that were treated with operation or radiation therapy.
- •2.Patients with clinically significant acute pulmonary dysfunction, idiopathic pulmonary fibrosis, ILD, pneumoconiosis or drug induced pneumonitis, or histories of these disease.
- •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 had major operation within 4 weeks before starting the study treatment and were not fully recovered
- •6.Patients who received any chemotherapy, EGFR-TKI treatment, radiation therapy or immunotherapy for cancer treatment except platinum-based, concurrent chemoradiation therapy
- •But patients who received Durvalumab treatment after platinum-based, concurrent chemoradiation therapy could be enrolled.
- •7.Patient with any unresolved toxicity CTCAE > Grade 2 from the prior chemoradiation therapy. But patients with irreversible toxicity that is not reasonably expected to be exacerbated by study drug may be included (eg, hearing loss, hair loss) after consultation with the coordination investigator
- •8.Patient with radiation pneumonitis CTCAE = Grade 2 from the prior chemoradiation therapy except patient who is tapering oral steroid off.
- •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 or glucose-galactose malabsorption
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