Immunological response of mutant EGFR-Targeted Peptide Vaccine Combined With EGFR Tyrosine kinase inhibitor (EGFR TKI) for Patients With Advanced Lung cancer harbouring EGFR mutations refractory to EGFR TKI treatment

CU Cancer Immunotherapy Fund, Thailand Science Research and Innovation (Fundamental Fund)0 个研究点目标入组 24 人开始时间: 2024年4月22日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1 Age at least 18 years
•2 Have histologically or cytologically-proven cancer of recurrent or advanced Lung cancer
•3 Have sensitive EGFR mutations in primary or metastatic tumor tissue
•4 Disease progression after first line EGFR TKI determined by primary oncologist
•5 Continuation of the same EGFR TKI beyond progression determined by primary oncologists decision.
•6 Measurable disease according to RECIST1.1
•7 Life expectancy of greater than 6 months
•8 ECOG Performance Status 0 or 1
•9 Have adequate organ and marrow function, as measured by laboratory values

•1 Active untreated brain or leptomeningeal metastasis
•2 Uncontrolled pleural effusion, pericardial effusions requiring recurrent drainage procedures (once monthly or more frequently)
•3 Active lung metastasis requiring oxygen support
•4 History of hypersensitivity to EGFR TKI
•5 History of hypersensitivity to poly-ICLC
•6 History of organ transplantation
•7 Has active autoimmune disease that has required systemic treatment in the past 2 years
•8 known HIV infections
•9 Any of the following cardiac criteria
•- Mean resting corrected QT interval (QTc) >470 msec
•- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg Complete left bundle branch block, third-degree heart block, second-degree heart block
•10 Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the Investigators opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
•11 Women who are pregnant or breast feeding

发起方

CU Cancer Immunotherapy Fund, Thailand Science Research and Innovation (Fundamental Fund)