Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC

Parc de Salut Mar

Status: Enrolling

Conditions: Stage III Lung Cancer; Lung Cancer; Unresectable Lung Carcinoma

Treatments: Diagnostic Test: Characterization of the tumoral tissue genomic alterations; Diagnostic Test: Genomic and methylation analysis in liquid biopsy; Drug: Chemoradiation treatment regimen and maintenance (if amenable); Procedure: Sample collection

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05641870

2022/10344/I

Details and patient eligibility

About

Multi-center observational clinical study to evaluate the application value of ctDNA monitoring in efficacy assessment and relapse prediction in patients diagnosed with unresectable, locally advanced NSCLC receiving CRT with or without durvalumab maintenance treatment.

Full description

Newly diagnosed, histologically confirmed, unresectable stage III NSCLC patients, amenable to receive standard of care chemoradiotherapy with or without durvalumab maintenance, will be enrolled in this study. Whole blood collection will be conducted during the treatment for ctDNA detection in specific time-points of interest. Next-generation sequencing using commercially available panels, and analysis of ctDNA aberrant methylation will be performed. Results will be correlated to patients' recurrence times and survival outcomes.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with newly diagnosed, histologically confirmed, unresectable locally advanced NSCLC.
• ≥18 years of age.
• Ability to understand the written informed consent and willingness to sign it.

Exclusion criteria

• Patients who are unwilling to follow-up evaluation of response to therapy.
• Any condition that, in the opinion of the investigator, would interfere with study results.