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

Phase 1

Recruiting

• Conditions: EGFR mutationNon-small cell lung cancerTherapeutic vaccine; EGFR mutation; Non-small cell lung cancer; Therapeutic vaccine

• Registration Number: TCTR20240422007
• Lead Sponsor: CU Cancer Immunotherapy Fund, Thailand Science Research and Innovation (Fundamental Fund)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-22
• Last Update Posted: 19 August 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T cell immunological response Day1, Day8, Day15, Day22, Day29, Day36, Day50, Day64 SFU per one million cells/ELISPOT

Secondary Outcome Measures

Name	Time	Method
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