MedTrace Logo

E GFR TKI and EGF-P TI C Ombination in EGFR mutA nt NSCL C

NCT03623750 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2022-06-30

No results posted yet for this study

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

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

EGFR-TK Inhibitor

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.

BIOLOGICAL

EGF-PTI

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 enter a maintenance phase during which reduced dose vaccinations will be performed every 2 or 3 months in conjunction with the interval between detailed check-up of the patient. As this interval can vary between patients, the interval for maintenance vaccination can also vary between 2 and 3 months.

DRUG

Cyclophosphamide

Eligible patients will receive a single pre-treatment of low dose of intravenous cyclophosphamide 200 mg/m2 (Day -3).

Sponsors & Collaborators

  • Bioven Europe

    collaborator INDUSTRY

  • MFAR

    collaborator OTHER

  • Instituto Oncológico Dr Rosell

    lead OTHER

Principal Investigators

  • Andrés Aguilar Hernández, M.D., PhD. · Instituto Oncológico Dr Rosell

  • Andrés Aguilar Hernández, M.D., PhD. · Instituto Oncológico Dr Rosell

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-06
Primary Completion
2020-03-26
Completion
2021-12-14

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623750 on ClinicalTrials.gov