Overcoming Resistance to EGFR Neutralization by Combination of Monoclonal Antibodies and Novel Cancer Drugs

NCT06863818 | Active Not Recruiting

• 2 other identifiers: OROLCTRC-2022-2773347
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study is aimed at patients with advanced cancer and EGFR mutation. Some molecules recently discovered at the level of tumor tissue can influence the response to anti-EGFR drugs. Among these molecules is NRG1, which binds to the EGFR receptor family. Unravelling the mechanisms that give cancer cells resistance to such biologics could improve response to therapy and survival. And analyzing tumors during anti-EGFR drug therapy used in clinical practice could allow us to perform analyses on NRG1 and hypothesize a possible strategy to increase survival

Conditions

Non Small Cell Lung Cancer

Keywords

EGFR mutation

Outcome Measures

Primary Outcomes (1)

• To evaluate in vitro the molecular mechanisms that regulate the expression of NRG1 and/or IL-1 in relation to ERBB family receptors (EGFR, HER2, HER3 and HER4) before and after the standard therapy resistance phase in patients with mutation in

  The expression of NRG1 and receptors of the ERBB family, pre- and post-treatment, and any receptors involved in resistance, including c-MET, IL-1R1, IL-1 and PD-L1, will be evaluated on tumor tissue. A qualitative and quantitative comparative evaluation of the expression of these genes between T0 and T2 will then be carried out. The expression of some cytokines including IL-1 and NRG1, at the T0, T1 and T2 timepoints, will be assessed by ELISA on blood and effusions (ascites, pleural fluid).

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary Outcomes (1)

• To evaluate the response to TKIs and/or mAbs of isolated tumor tissue before and after the resistance phase to standard therapy in patients with EGFR mutation and propagated in vitro, in the presence of the lymphocyte component (T lymphocytes). The devel

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have EGFR receptor amplification/overexpression or activating mutations, either responsive to anti-EGFR therapy (TKIs or mABs) or recurrent despite anti-EGFR therapy (TKIs or mABs), will be enrolled in the study.

You may qualify if:

• patients aged ≥ 18 years
• patients with advanced cancer characterized by amplification/overexpression or activating mutations of the EGFR receptor.
• patients who are candidates for treatment with TKI and/or mAbs both in the first and second line, according to clinical practice.
• possibility of obtaining all information relating to the clinical history - obtaining written informed consent

You may not qualify if:

• Patients who in the opinion of the investigator may not be compliant with the needs of the study
• patients suffering from pathologies (e.g. psychiatric, neurological) that do not allow the obtaining of valid informed consent

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma and tumor tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andrea Ardizzoni, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: March 7, 2025
• Study Start: October 10, 2022
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)