MedTrace Logo

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

NCT05641870 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2022-12-12

No results posted yet for this study

Summary

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.

Conditions

  • Lung Cancer
  • Stage III Lung Cancer
  • Unresectable Lung Carcinoma

Interventions

PROCEDURE

Sample collection

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.

DIAGNOSTIC_TEST

Characterization of the tumoral tissue genomic alterations

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

DRUG

Chemoradiation treatment regimen and maintenance (if amenable)

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.

DIAGNOSTIC_TEST

Genomic and methylation analysis in liquid biopsy

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.

Sponsors & Collaborators

  • Guardant Health, Inc.

    collaborator INDUSTRY

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Edurne Arriola · Parc de Salut Mar

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05641870 on ClinicalTrials.gov