EGFR mutation Non-small cell lung cancer Therapeutic vaccine EGFR mutation Non-small cell lung cancer Therapeutic vaccine
Conditions
Interventions
Mutant EGFR-Targeted Peptide Vaccine plus poly-ICLC as adjuvant will be applied for 8 times over 9 weeks (D1, D8, D15, D22, D29, D36, D50, D64) in combination with continuation of EGFR TKI treatment
Experimental Biological/Vaccine
Vaccine
Sponsors
CU Cancer Immunotherapy Fund, Thailand Science Research and Innovation (Fundamental Fund)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T cell immunological response Day1, Day8, Day15, Day22, Day29, Day36, Day50, Day64 SFU per one million cells/ELISPOT | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety All Grade/NCTCAE v5.0,Objective response rate (ORR) Week 10 percentage/RECIST v1.1,1 year Progression Free Survival (PFS) 1 year percentage/ 1 year PFS | — |
Countries
Thailand
Contacts
Public ContactPiyada Sitthideatphaiboon
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed