NCT03623750: EPICAL

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

Completed Phase 1, PHASE2 Last updated 30 June 2022

What this trial tests

Phase 1, PHASE2 trial testing EGFR-TK Inhibitor in Carcinoma, Non-Small-Cell Lung in 23 participants. Completed in 14 December 2021.

Timeline

6 July 2018

Primary endpoint
26 March 2020

14 December 2021

Quick facts

Lead sponsor	Instituto Oncológico Dr Rosell
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	23
Start date	6 July 2018
Primary completion	26 March 2020
Estimated completion	14 December 2021
Sites	4 locations across Spain

Drugs / interventions tested

• EGFR-TK Inhibitor — full drug profile →
• EGF-PTI — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →

Sponsor

Instituto Oncológico Dr Rosell — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protein tyrosine kinase inhibitor resistance in malignant tumors: molecular mechanisms and future perspective.
   Yang Y, Li S, Wang Y, Zhao Y, et al · · 2022 · cited 182× · PMID 36115852 · DOI 10.1038/s41392-022-01168-8
2. EGFR first- and second-generation TKIs-there is still place for them in <i>EGFR</i>-mutant NSCLC patients.
   Karachaliou N, Fernandez-Bruno M, Bracht JWP, Rosell R. · · 2019 · cited 84× · PMID 35117062 · DOI 10.21037/tcr.2018.10.06
3. Nanomedicine in Non-Small Cell Lung Cancer: From Conventional Treatments to Immunotherapy.
   García-Fernández C, Fornaguera C, Borrós S. · · 2020 · cited 29× · PMID 32570729 · DOI 10.3390/cancers12061609
4. Drug resistance of targeted therapy for advanced non-small cell lung cancer harbored EGFR mutation: from mechanism analysis to clinical strategy.
   Zhao Y, Wang H, He C. · · 2021 · cited 26× · PMID 34661758 · DOI 10.1007/s00432-021-03828-8
5. The Position of EGF Deprivation in the Management of Advanced Non-Small Cell Lung Cancer.
   Crombet Ramos T, Santos Morales O, Dy GK, León Monzón K, et al · · 2021 · cited 12× · PMID 34211836 · DOI 10.3389/fonc.2021.639745
6. Anti-epidermal growth factor vaccine antibodies increase the antitumor activity of kinase inhibitors in ALK and RET rearranged lung cancer cells.
   Codony-Servat J, García-Roman S, Molina-Vila MÁ, Bertran-Alamillo J, et al · · 2021 · cited 8× · PMID 33129112 · DOI 10.1016/j.tranon.2020.100887
7. A Comprehensive Review of Contemporary Literature for Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancer and Their Toxicity.
   Lee CS, Sharma S, Miao E, Mensah C, et al · · 2020 · cited 8× · PMID 33117017 · DOI 10.2147/lctt.s258444
8. Lung cancer vaccine strategies: exploring the spectrum from traditional to RNA-based platforms.
   Pazoki A, Dadfar S, Alirezaee A, Oksenych V, et al · · 2025 · cited 2× · PMID 40625850 · DOI 10.3389/fbioe.2025.1617352