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

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ClinicalTrials.gov Identifier: NCT05641870
Recruitment Status : Recruiting
First Posted : December 8, 2022
Last Update Posted : December 12, 2022
Sponsor:
Collaborator:
Guardant Health, Inc.
Information provided by (Responsible Party):
Edurne Arriola, Parc de Salut Mar

Study Description
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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.

Condition or disease Intervention/treatment
Lung Cancer Stage III Lung Cancer Unresectable Lung Carcinoma Procedure: Sample collection Diagnostic Test: Characterization of the tumoral tissue genomic alterations Drug: Chemoradiation treatment regimen and maintenance (if amenable) Diagnostic Test: Genomic and methylation analysis in liquid biopsy

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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 16 Months
Official Title: Molecular Profiling and Dynamic Changes of Circulating Tumor DNA in Unresectable Locally Advanced Non-small Cell Lung Cancer
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.


Outcome Measures
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Primary Outcome Measures :
  1. Quantitative variation of aberrant methylated ctDNA concentrations before chemoradiotherapy, after chemoradiotherapy, and every 3 months during 1 year of follow-up. [ Time Frame: 16 months ]
  2. Correlation between patients' recurrence or progression, and quantitative detection of circulating tumour DNA (ctDNA) concentration. [ Time Frame: 2 years ]
  3. Concordance of ctDNA genomic alterations detected in peripheral blood samples, with those in matched tumour samples. [ Time Frame: At diagnosis ]
  4. Correlation between survival outcomes (progression free survival, overall survival) and quantitative detection of ctDNA genomic alterations or methylation status. [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Tumor samples from tissue biopsy or citology. Whole blood samples.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05641870


Contacts
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Contact: Edurne Arriola 932483137 ext +34 earriola@psmar.cat
Contact: Pedro Rocha 932483137 psimoes@psmar.cat

Locations
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Spain
Parc de Salut Mar - Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Edurne Arriola    932483137    earriola@psmar.cat   
Contact: Pedro Rocha    932483137    psimoes@psmar.cat   
Sponsors and Collaborators
Parc de Salut Mar
Guardant Health, Inc.
Investigators
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Principal Investigator: Edurne Arriola Parc de Salut Mar
More Information
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Publications:

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Responsible Party: Edurne Arriola, Principal Investigator, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT05641870    
Other Study ID Numbers: 2022/10344/I
First Posted: December 8, 2022    Key Record Dates
Last Update Posted: December 12, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Edurne Arriola, Parc de Salut Mar:
Liquid biopsy
ctDNA
Chemoradiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases