Status:
UNKNOWN
Prospective Study on Resistance-associated Mutations in Metastatic Lung Cancer
Lead Sponsor:
University of Milano Bicocca
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Brief 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 wit...
Detailed Description
Non-small-cell lung cancer (NSCLC) is a heterogeneous disease that may have several genetic alterations in oncogenes responsible for progression. 30-40% of NSCLC patients carry mutations affecting the...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Under 18 years of age
- Unconfirmed histological diagnosis
- Absence of rearrangement or mutation of ALK, ROS1, MET, RET, NTRK, KRAS-G12C or BRAF-V600E
- Progression to chemotherapy in the absence of treatment with TKI or RAS or BRAF inhibitor
- Unmeasurable disease
Key Trial Info
Start Date :
December 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06081270
Start Date
December 12 2021
End Date
December 31 2024
Last Update
October 13 2023
Active Locations (1)
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1
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, Italy, 20900