Using circulating tumor DNA to improve outcomes for advanced colorectal and non–small cell lung cancer

Circulating DNA to Improve Outcome of Oncology PatiEnt: A Randomized Study - COPE Study

This test checks whether tracking tumor DNA in the blood, alongside tumor sequencing, helps guide first-line treatment for adults with advanced colorectal cancer or non–small cell lung cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 332 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut Bergonié (Academic / other)
• Locations: 6 sites (Bayonne and 5 other locations)
• Trial ID: NCT04258137 on ClinicalTrials.gov

What this trial studies

COPE runs two parallel randomized phase II trials (one for colorectal cancer, one for non–small cell lung cancer) with a 2:1 allocation between arms. All patients undergo tumor genetic profiling and multidisciplinary tumor board (MTB) review to recommend therapy; the experimental arm adds regular circulating tumor DNA (ctDNA) monitoring combined with standard imaging, while the control arm uses standard imaging alone for follow-up. The protocol aims to use ctDNA as a less invasive, more comprehensive way to track tumor evolution and detect actionable alterations or early progression. The primary hypothesis is that sequential ctDNA analysis can improve clinical management and survival compared with imaging alone.

Who should consider this trial

Good fit: Adults (≥18) with untreated, locally advanced/unresectable or metastatic colorectal cancer or non–small cell lung cancer, ECOG performance status 0–1, measurable disease, available tumor tissue or a biopsyable lesion, eligible for first-line systemic therapy and covered by French social security.

Not a fit: Patients who have already received systemic treatment for advanced disease, have poor performance status, lack detectable ctDNA, or cannot provide tumor tissue are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, using ctDNA could allow earlier detection of progression or resistance and more timely, personalized treatment changes that improve outcomes.

How similar studies have performed: Prior studies show ctDNA can reliably detect tumor mutations and early progression and has guided therapy changes in some settings, but randomized evidence that ctDNA-guided management improves survival remains limited.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years,
2. Histology: colorectal cancer, non-small cell lung cancer,
3. Locally advanced/unresectable and/or metastatic solid tumor,
4. Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Appendix 1),
5. Measurable disease according to RECIST 1.1 (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally \> 10 mm,
6. No previous systemic treatment for advanced disease,
7. Availability of suitable paraffin embedded (FFPE) archive tumor material or at least one target lesion that can be biopsied for research purpose,
8. Eligible to first-line systemic therapy,
9. Patient with a social security in compliance with the French law,
10. Voluntary signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

1. Inability to swallow,
2. Major problem with intestinal absorption,
3. Previous allogeneic bone marrow transplant,
4. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin and prostate cancer,
5. Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),
6. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in a clinical trial or which would jeopardize compliance with the protocol,
7. Individuals deprived of liberty or placed under guardianship,
8. Pregnant or breast feeding women,
9. Previous enrolment in the present study,
10. Any contraindication to first-line systemic therapy.

Where this trial is running

Bayonne and 5 other locations

• Centre hospitalier de la Côte Basque — Bayonne, France (Recruiting)
• Clinique Tivoli-Ducos — Bordeaux, France (Recruiting)
• Institut Bergonie — Bordeaux, France (Recruiting)
• Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (Recruiting)
• CHRU Brest — Brest, France (Recruiting)
• Polyclinique Marzet — Pau, France (Recruiting)

Study contacts

• Study coordinator: Antoine ITALIANO, MD, PhD

Conditions Colorectal Cancer; Non Small Cell Lung Cancer; advanced; metastatic; liquid biopsy; genetic profiling