A Phase II, Multicenter Study of Lazertinib as Consolidation Therapy in Patients with Locally Advanced, Unresectable, EGFR Mutation positive Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed following Definitive, Platinum-based, Chemoradiation Therapy (PLATINUM Trial)

Koera University Guro Hospital0 个研究点目标入组 77 人开始时间: 待定最近更新: 2023年2月8日

试验速览

暂无简介。

•1. 18 years and older
•2. Histologically and cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) non-squamous cell carcinoma who present with locally advanced, unresectable, Stage III disease
•3. ECOG PS 0,1
•4. Expected life expectancy of 6 months and more
•5. Patients who have received at least 2 cycles of definitive platinum-based concurrent chemoradiation therapy (CCRT) and who must be within 1 to 42 days after completion of radiation therapy
•6. Patients must not have had disease progression during or following CCRT
•7. Patients with adequate organ and bone marrow function
•8. Patients who give in written consent voluntarily to participate in this study

•1. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation interstitial pneumonia
•2. History of other primary malignancy
•3. Mixed small cell and NSCLC histology
•4. Prior treatment with EGFR-TKI Therapy
•5. Unresolved toxicity of CTCAE grade 2 or higher following chemoradiation
•6. Current history of CTCAE grade 2 or higher pneumonia prior to chemoradiation therapy
•7. Patients with severe hypersensitivity to active ingredient or excipient of the investigational medicinal product
•8. Pregnant or breastfeeding patients
•9. Patients who do not agree to contraception with medically acceptable method for at least 6 months after the end of study intervention treatment
•10. Patients who participated in clinical trials within 4 weeks before participating in this study
•11. Judgment by the investigator that the patient is unsuitable to participate in this study

发起方

Koera University Guro Hospital