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

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).

Eligibility

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.

Conditions4

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