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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Stage III NSCLC with curative intent treatment

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ctDNA

    Diagnostic test

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

Treatment groups

248 Participants
are divided into 3 treatment groups
Group A: Chemo-radiotherapy1 intervention
Group B: Neoadjuvant and surgery1 intervention
Group C: Surgery and adjuvant immunotherapy1 intervention

Trial outcomes

Primary outcomes

1

Collection of clinical plasma samples at relevant time points

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

Time frame
8 months after end of recruitment

Secondary outcomes

1

The 3-year recurrence-free survival

recurrence free survival by RECIST1.1

Time frame
3 years after end of recruitment
2

Lead time between ctDNA detection and clinical recurrence

recurrence by RECIST1.1

Time frame
3 years after end of recruitment
3

Prognostic value of ctDNA analysis at relevant time points

for complete pathological response, disease progression, event free and overall survival

Time frame
3 years after end of recruitment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

LungenClinic Grosshansdorf

Collaborator

Centre Hospitalier Universitaire de Nice

Collaborator