Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Stage III NSCLC

NCT06111807 | Recruiting

• 1 other identifier: GUIDE.MRD-03-NSCLC
• Study Type: observational
• Target: 248
• Locations: 3 countries
• Sites: 6

Brief Summary

Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for non small cell lung cancer (NSCLC), the methods used to decide who gets additional post radical (surgery or definite chemo-radiotherapy) treatment are suboptimal. Some patients get too much treatment, while others do not get enough. There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points. The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient. GUIDE.MRD-03-NSCLC is a part of the GUIDE.MRD project.

Conditions

Lung Cancer Stage III

Keywords

Circulating tumor DNA; ctDNA diagnostics; Minimal residual disease; Sensitivity; Specificity; complete pathological response

Outcome Measures

Primary Outcomes (1)

• Collection of clinical plasma samples at relevant time points

  For head-to-head performance assessment and benchmarking of ctDNA diagnostics

  8 months after end of recruitment

Secondary Outcomes (3)

• The 3-year recurrence-free survival

  3 years after end of recruitment

• Lead time between ctDNA detection and clinical recurrence

  3 years after end of recruitment

• Prognostic value of ctDNA analysis at relevant time points

  3 years after end of recruitment

Study Arms (3)

Chemo-radiotherapy

Stage 3 NSCLC eligible for chemoradiotherapy

Diagnostic Test: ctDNA

Neoadjuvant and surgery

Stage 3 NSCLC eligible for neoadjuvant chemo-immunotherapy followed by surgery

Diagnostic Test: ctDNA

Surgery and adjuvant immunotherapy

Stage 3 NSCLC eligible for surgery followed by immunotherapy

Diagnostic Test: ctDNA

Interventions

ctDNA DIAGNOSTIC_TEST

ctDNA will be tested retrospectively, no treatment decisions will be made prospectively

Chemo-radiotherapy; Neoadjuvant and surgery; Surgery and adjuvant immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage III NSCLC with curative intent treatment

You may qualify if:

• NSCLC, clinical tumor stage III (cT1-4, cN0-3, M0).
• Patient 18 years or older.
• Scheduled for curative intent treatment (surgery and/or radiotherapy).
• Patient able to understand and sign written informed consent.
• Baseline contrast enhanced CT thorax abdomen (or PET/CT), MRI (or CT) brain, Pulmonary function tests (at least FEV1 and DLCO/KCO).
• Ability to obtain sufficient tumor material (≥50ng tumor DNA, FFPE ). Either at baseline or after surgery.

You may not qualify if:

• Verified distant metastases.
• With synchronous NSCLC cancer and non-NSCLC cancer (except skin cancer other than melanoma).
• With other cancers (excluding NSCLC or skin cancer other than melanoma, or cancers treated curatively with follow up of more than 5 years without recurrence).
• Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study.
• No tissue sample available for the project, or tumor content in the tissue sample is \<20%

Sponsors & Collaborators

• University Medical Center Groningen: lead
• LungenClinic Grosshansdorf: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator

Study Sites (6)

Centre Hospitalier Universitaire de Nice

Nice, Nice, 06000, France

RECRUITING

Antoine Lacassagne Center

Nice, Nice, 06189, France

NOT YET RECRUITING

Department of thoracic oncology- LungenClinic Großhansdorf

Großhansdorf, Grosshansdorf, 22927, Germany

NOT YET RECRUITING

Isala

Zwolle, Overijssel, 8025AB, Netherlands

RECRUITING

University Medical Center Groningen, Departments of Pulmonology and Pathology

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

Ommelander Ziekenhuis Groningen

Scheemda, Provincie Groningen, 9679BJ, Netherlands

RECRUITING

Related Links

• Webpage of the GUIDE.MRD project

Biospecimen

Retention: SAMPLES WITH DNA

Full blood samples processed into plasma, buffy coat,and serum Formalin-fixed paraffin-embedded tumor tissue

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm, Residual; Hypersensitivity; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases; Disease Progression; Disease Attributes

Study Officials

• Mustafa Abdo, MD

  LungenClinic Grosshansdorf

  STUDY CHAIR

• Paul Hofman, MD, PhD

  Centre Hospitalier Universitaire (CHU) de Nice

  STUDY CHAIR

Central Study Contacts

T.Jeroen N Hiltermann, MD, PhD

CONTACT

503644936; t.j.n.hiltermann@umcg.nl

Ed Schuuring, PhD

CONTACT

503619623; e.schuuring@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: November 1, 2023
• Study Start: November 10, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 31, 2030
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

DE (1); NL (3); FR (2)