Analyzing resistance mutations in metastatic lung cancer using liquid biopsy
Prospective Study on Resistance-associated Mutations in Metastatic Lung Neoplasm Patients With Alterations in Driver Oncogenes, Except EGFR, Undergoing Treatment With Specific Inhibitors
This study is testing if a blood test can help find changes in the genes of lung cancer tumors in patients who are being treated, to better understand how the cancer might resist treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Monza, MB) |
| Trial ID | NCT06081270 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with metastatic non-small-cell lung cancer (NSCLC) who have specific genetic mutations. It employs liquid biopsy techniques to analyze circulating tumor DNA for resistance mutations that may develop during treatment with selective inhibitors. By utilizing next-generation sequencing, the study aims to provide insights into tumor heterogeneity and monitor treatment responses over time. The research is conducted at the San Gerardo Hospital in Monza, Italy.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with inoperable metastatic or locally advanced lung cancer and specific genetic mutations or rearrangements.
Not a fit: Patients without the specified genetic mutations or those with operable lung cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of drug resistance in lung cancer, potentially enhancing treatment outcomes.
How similar studies have performed: Other studies utilizing liquid biopsy for monitoring resistance mutations in cancer have shown promising results, indicating the potential effectiveness of this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Over 18 years of age. 2. Histological diagnosis of inoperable metastatic or locally advanced lung cancer. 3. Positivity for ALK, ROS1, MET, RET (Rearranged during transfection), NTRK (NEUROTROPHIC TYROSINE RECEPTOR KINASE) rearrangements, or KRAS (Kirsten rat sarcoma)-G12C (glycine 12 cysteine) or BRAF-V600E (valine 600 glutamate) mutations, detected by validated method (IHC Immunohistochemistry 3+, FISH (fluorescence in situ hybridization) or Next Generation Sequencing). 4. Patients undergoing radiological progression according to RECIST 1.1 criteria to treatment with generation I, II or III inhibitors in any line of treatment. Patients may also have been pre-treated with chemotherapy in earlier lines. 5. Presence of measurable disease on radiological investigations. Patients with brain metastases, even as a single site of disease, are eligible for the study. 6. Informed consent freely given and obtained before the start of the study. Exclusion Criteria: 1. Under 18 years of age 2. Unconfirmed histological diagnosis 3. Absence of rearrangement or mutation of ALK, ROS1, MET, RET, NTRK, KRAS-G12C or BRAF-V600E 4. Progression to chemotherapy in the absence of treatment with TKI or RAS or BRAF inhibitor 5. Unmeasurable disease
Where this trial is running
Monza, MB
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Mb, Italy (Recruiting)
Study contacts
- Principal investigator: Diego Cortinovis, MD — Fondazione IRCCS San Gerardo dei Tintori, Monza
- Study coordinator: Clinical Trial Administration
- Email: onco.noprofit@gmail.com
- Phone: +390392333203
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.