Clinical trial NCT05641870: Molecular Profiling and Dynamic Changes of ctDNA in Unresectable Locally Advanced NSCLC
Official title: Molecular Profiling and Dynamic Changes of Circulating Tumor DNA in Unresectable Locally Advanced Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Stage III Lung Cancer
Unresectable Lung Carcinoma
Keywords: Liquid biopsy
ctDNA
Chemoradiotherapy
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Guardant Health, Inc.
First posted: 2022-12-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Quantitative variation of aberrant methylated ctDNA concentrations before chemoradiotherapy, after chemoradiotherapy, and every 3 months during 1 year of follow-up.
timeFrame: 16 months
measure: Correlation between patients' recurrence or progression, and quantitative detection of circulating tumour DNA (ctDNA) concentration.
timeFrame: 2 years
measure: Concordance of ctDNA genomic alterations detected in peripheral blood samples, with those in matched tumour samples.
timeFrame: At diagnosis
measure: Correlation between survival outcomes (progression free survival, overall survival) and quantitative detection of ctDNA genomic alterations or methylation status.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Parc de Salut Mar - Hospital del Mar
Study officials:
affiliation: Parc de Salut Mar
name: Edurne Arriola
role: PRINCIPAL_INVESTIGATOR
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