Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Durvalumab

Tumor samples will be collected as standard diagnostic procedure at diagnosis. Plasma samples from whole blood extractions will also be collected at diagnosis, after chemoradiotherapy, and every 3 months from there until completing one year of follow-up.

Sample collection

Genomic alterations of tumor tissue samples will be analyzed locally by next-generation sequencing when material is adequate, as standard diagnostic procedure.

Characterization of the tumoral tissue genomic alterations

Patients will be treated with standard chemotherapy (following the clinical practice at each institution). Radiotherapy will be delivered concurrently when feasible with a total dose of 60-66 Gy. In selected cases, due to frailty of the patient or impaired pulmonary function, radiotherapy will be delivered sequentially. In tumors with positive PD-L1 expression, a year of durvalumab 10 mg/m2 every 2 weeks will be administered if there are no contraindications.

Chemoradiation treatment regimen and maintenance (if amenable)

Blood samples for ctDNA genomic and methylation analysis (4 mL of plasma for each sample) will be sent to the Guardant Health Laboratories in the US and analyzed after Contractual Agreement signature, using the Guardant Reveal test.

This liquid biopsy test uses ctDNA to detect presence of MRD and monitor for recurrence after definitive surgical/systemic therapy for patients with cancer. It has been validated in early-stage colorectal cancer and integrates assessment of somatic alterations with an epigenomic cancer signature to identify the presence of methylation signatures associated with cancer versus normal DNA.

Genomic and methylation analysis in liquid biopsy

Edurne Arriola

Pedro Rocha

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.

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.

Tumor samples from tissue biopsy or citology. Whole blood samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC	NCT05641870	Lung Cancer Stage III Lung ... Unresectable Lu...	Sample collecti... Characterizatio... Chemoradiation ... Genomic and met...	18 Years -	Parc de Salut Mar
Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC	NCT05641870	Lung Cancer Stage III Lung ... Unresectable Lu...	Sample collecti... Characterizatio... Chemoradiation ... Genomic and met...	18 Years -	Parc de Salut Mar
Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC	NCT05641870	Lung Cancer Stage III Lung ... Unresectable Lu...	Sample collecti... Characterizatio... Chemoradiation ... Genomic and met...	18 Years -	Parc de Salut Mar

Spots Global Cancer Trial Database for characterization of the tumoral tissue genomic alterations