E GFR TKI and EGF-P TI C Ombination in EGFR mutA nt NSCL C
Status:
Active, not recruiting
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
This is a multicentre, open-label, uncontrolled, Phase Ib clinical study. Patients who give
informed consent will be screened for the study, including genotyping of the tumour and
baseline characteristics. Eligible patients will receive a single pre-treatment of low dose
of intravenous cyclophosphamide 200 mg/m2 (Day -3). Patients will commence daily oral therapy
with the EGFR TKI afatinib as soon as possible, preferably on the same day as low dose
cyclophosphamide. Afatinib will be prescribed according to the Summary of Product
Characteristics (SmPC) of the product, and will continue in nominal 21-day cycles for as long
as clinically indicated. The first day of dosing with EGF-PTI will be designated Day 1.
Immunisation with EGF-PTI will commence 3 days after low dose cyclophosphamide and
commencement of EGFR TKI, and will be repeated on Day 14, Day 28, Day 43, and Day 92. After
the 5 th vaccination, patients will be followed up every 6 weeks for basic safety data and
every 3 months for complete efficacy data, safety data, and maintenance (reduced) doses of
EGF-PTI. Patients will continue in the study until disease progression, death, safety
concerns (in the opinion of the investigator), non-compliance with the protocol, the patient
withdraws from the study, 1 year after randomisation of the last patient, or the study is
stopped the sponsor, whichever occurs sooner
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Instituto Oncológico Dr Rosell
Collaborators:
Bioven (Europe) Limited Bioven Europe MFAR MFAR Clinical Research