Clinical trial · Observational
Overcoming Resistance to EGFR Neutralization by Combination of Monoclonal Antibodies and Novel Cancer Drugs
Overcoming Resistance to EGFR Neutralization by Combination of Monoclonal Antibodies and Novel Cancer Drugs (Superamento Della Resistenza Alla Neutralizzazione di EGFR Nel Trattamento Con Anticorpi Monoclonali e Nuovi Farmaci Oncologici)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- 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
- description
- 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).
Secondary outcomes (1)
- measure
- 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
- timeFrame
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available