Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study

NCT04258137 | Recruiting

• 3 other identifiers: IB 2019-062019-A02479-48ML41112
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 6

Brief Summary

COPE is a biology driven protocol with 2 independent, multicentric, two-arm non-comparative randomized (2:1) phase II trials in 2 distinct populations: colorectal cancer patients and non-small-lung cancer patients. For each phase II trial, patient will be randomized between two arms with two patients randomized in arm A for one patient randomized in arm B:

• Arm A (Experimental - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis)
• Arm B (Standard - initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging).

Conditions

Colorectal Cancer; Non Small Cell Lung Cancer

Keywords

advanced; metastatic; liquid biopsy; genetic profiling

Outcome Measures

Primary Outcomes (1)

• Assessment of cancer outcome in terms of overall survival (2 distincts population)

  Overall Survival (OS) is defined as the time interval between the date of randomization and the date of death (of any cause).

  18 months

Secondary Outcomes (2)

• Proportion of patients with at least one actionable alteration (in 2 distincts populations)

  Throughout the study: an average of 18 months

• Proportion of patients treated with a targeted therapy (in 2 distincts populations)

  Throughout the study: an average of 18 months

Study Arms (4)

Experimental procedure for colorectal cancer

EXPERIMENTAL

Patients with Advanced colorectal cancer will be managed by initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis (subsequent MTBs at each radiological assessment)

Genetic: Liquid biopsy

Standard procedure for colorectal cancer

NO INTERVENTION

Patients with Advanced colorectal cancer will be managedby initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging.

Experimental procedure for non-small cell lung cancer

EXPERIMENTAL

Patients with Advanced non-small cell lung cancer will be managed by initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis (subsequent MTBs at each radiological assessment)

Genetic: Liquid biopsy

Standard procedure for non-small cell lung cancer

NO INTERVENTION

Patients with Advanced non-small cell lung cancer will be managed by initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging.

Interventions

Liquid biopsy GENETIC

Liquid biopsy will be performed at cycle 1 day 1 and cycle 2 day of each line of systemic treatment, at each tumor evaluation by Imaging and at confirmation of progression

Experimental procedure for colorectal cancer; Experimental procedure for non-small cell lung cancer

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years,
• Histology: colorectal cancer, non-small cell lung cancer,
• Locally advanced/unresectable and/or metastatic solid tumor,
• Eastern Cooperative Oncology Group (ECOG) performance status \< 2 (Appendix 1),
• No previous systemic treatment for advanced disease,
• Availability of suitable paraffin embedded (FFPE) archive tumor material or at least one target lesion that can be biopsied for research purpose,
• Eligible to first-line systemic therapy,
• Patient with a social security in compliance with the French law,
• Voluntary signed and dated written informed consent prior to any study specific procedure.

You may not qualify if:

• Inability to swallow,
• Major problem with intestinal absorption,
• Previous allogeneic bone marrow transplant,
• 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,
• Evidence of severe or uncontrolled systemic disease (uncontrolled hypertension, active bleeding diatheses, or active Hepatitis B, C and HIV),
• 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,
• Individuals deprived of liberty or placed under guardianship,
• Pregnant or breast feeding women,
• Previous enrolment in the present study,
• Any contraindication to first-line systemic therapy.

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (6)

Centre hospitalier de la Côte Basque

Bayonne, 64109, France

RECRUITING

Clinique Tivoli-Ducos

Bordeaux, 33000, France

RECRUITING

Institut Bergonie

Bordeaux, 33076, France

RECRUITING

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33077, France

RECRUITING

CHRU Brest

Brest, 29200, France

RECRUITING

Polyclinique Marzet

Pau, 64000, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Central Study Contacts

Antoine ITALIANO, MD, PhD

CONTACT

5.56.33.33.33; a.italiano@bordeaux.unicancer.fr

Simone MATHOULIN-PELISSIER, MD, PhD

CONTACT

s.mathoulin@bordeaux.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For each distinct population of patients with Advanced solid tumor (colorectal cancer and non-small-cell lung cancer), patients will be randomized between two arms: Experimental procedure: initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up combining standard imaging and ctDNA analysis (subsequent MTBs at each radiological assessment). Standard procedure: initial MTB providing therapeutic recommendation based on tumor sequencing and then follow-up based on standard imaging.

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: September 4, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)