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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

Tracking Information
First Submitted Date November 29, 2022
First Posted Date December 8, 2022
Last Update Posted Date December 12, 2022
Actual Study Start Date February 1, 2021
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 29, 2022)
  • 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 ]
  • Correlation between patients' recurrence or progression, and quantitative detection of circulating tumour DNA (ctDNA) concentration. [ Time Frame: 2 years ]
  • Concordance of ctDNA genomic alterations detected in peripheral blood samples, with those in matched tumour samples. [ Time Frame: At diagnosis ]
  • Correlation between survival outcomes (progression free survival, overall survival) and quantitative detection of ctDNA genomic alterations or methylation status. [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 16 Months
Biospecimen Retention:   Samples With DNA
Description:
Tumor samples from tissue biopsy or citology. Whole blood samples.
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.
Condition
  • Lung Cancer
  • Stage III Lung Cancer
  • Unresectable Lung Carcinoma
Intervention
  • 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 29, 2022)		 80
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Edurne Arriola 932483137 ext +34 earriola@psmar.cat
Contact: Pedro Rocha 932483137 psimoes@psmar.cat
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT05641870
Other Study ID Numbers 2022/10344/I
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Edurne Arriola, Parc de Salut Mar
Original Responsible Party Edurne Arriola, Parc de Salut Mar, Dr.
Current Study Sponsor Parc de Salut Mar
Original Study Sponsor Same as current
Collaborators Guardant Health, Inc.
Investigators
Principal Investigator: Edurne Arriola Parc de Salut Mar
PRS Account Parc de Salut Mar
Verification Date December 2022