Prospective Study on Resistance-associated Mutations in Metastatic Lung Neoplasm Patients With Alterations in Driver Oncogenes, Except EGFR, Undergoing Treatment With Specific Inhibitors

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

This single-centre prospective study is aimed at analysing, by means of liquid biopsy with next generation sequencing analysis on circulating tumor DNA, resistance mutations arising during therapy with selective inhibitors in patients with RTK-positive NSCLC or with mutations in the Ras/MAPK (mitogen-activated protein kinase) pathway, treated at the San Gerardo Hospital, Monza.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Over 18 years of age.

• Histological diagnosis of inoperable metastatic or locally advanced lung cancer.

• 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).

• 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.

• Presence of measurable disease on radiological investigations. Patients with brain metastases, even as a single site of disease, are eligible for the study.

• Informed consent freely given and obtained before the start of the study.

Locations
Other Locations
Italy
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
Contact Information
Primary
Clinical Trial Administration
onco.noprofit@gmail.com
+390392333203
Backup
Luca Mologni, PhD
luca.mologni@unimib.it
Time Frame
Start Date: 2021-12-12
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 20
Related Therapeutic Areas
Sponsors
Leads: University of Milano Bicocca

This content was sourced from clinicaltrials.gov