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Trial Title:
Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC
NCT ID:
NCT05641870
Condition:
Lung Cancer
Stage III Lung Cancer
Unresectable Lung Carcinoma
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Liquid biopsy
ctDNA
Chemoradiotherapy
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Sample collection
Description:
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.
Intervention type:
Diagnostic Test
Intervention name:
Characterization of the tumoral tissue genomic alterations
Description:
Genomic alterations of tumor tissue samples will be analyzed locally by next-generation
sequencing when material is adequate, as standard diagnostic procedure.
Intervention type:
Drug
Intervention name:
Chemoradiation treatment regimen and maintenance (if amenable)
Description:
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.
Intervention type:
Diagnostic Test
Intervention name:
Genomic and methylation analysis in liquid biopsy
Description:
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.
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Newly diagnosed, histologically confirmed, unresectable stage III NSCLC patients,
amenable to receive standard of care chemoradiotherapy with or without durvalumab
maintenance.
Patients will be recruited in two centers: Hospital del Mar (Barcelona, Spain) and
Instituto Português de Oncologia (Porto, Portugal). The expected number of enrolments is
30-40 patients per year per institution. All patients will be informed of the research
nature of the study and will be included after written informed consent is provided.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Parc de Salut Mar - Hospital del Mar
Address:
City:
Barcelona
Zip:
08003
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Edurne Arriola
Phone:
932483137
Email:
earriola@psmar.cat
Contact backup:
Last name:
Pedro Rocha
Phone:
932483137
Email:
psimoes@psmar.cat
Start date:
February 1, 2021
Completion date:
December 2023
Lead sponsor:
Agency:
Parc de Salut Mar
Agency class:
Other
Collaborator:
Agency:
Guardant Health, Inc.
Agency class:
Industry
Source:
Parc de Salut Mar
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05641870
