The Added Value of Tissue or Liquid Biopsy NGS Profiling in Advanced Solid Tumor Treatment Decisions.

GeNeo 2.0 Study PRIMARY OBJECTIVE AND ENDPOINTS

To describe the genomic landscape of advanced solid tumors and primary CNS cancer as evaluated by CGP of tumor or ctDNA (for all included patients and tumor types separate). To do so, following calculations will be performed :

• Prevalence of ESCAT level 1, 2, 3 or 4 alterations based on MTB discussion of Roche AVENIO Tumor Tissue CGP kit results.
• Prevalence of ESCAT level 1, 2, 3 or 4 alterations based on MTB discussion of Foundation One Liquid CDx results.
• Prevalence of genomic alterations according to altered gene, type of variant of tumor type.

GeNeo 2.0 Study SECONDARY OBJECTIVES AND ENDPOINTS

• To describe the number of patients receiving a treatment recommendation by the MTB.
• To describe the uptake of the MTB recommendations.
• To evaluate the treatment recommendations proposed by the MTB.
• To evaluate the reasons for discordance between the actual treatment and MTB recommendation.
• To evaluate the turnaround time of tumor CGP and ctDNA testing.
• To evaluate the technical success rate of tumor CGP and ctDNA testing.
• To evaluate the impact of CGP on patient referral and trial inclusion.

All secondary analyses will be performed for all included patients, for tumor/ctDNA CGP testing and for tumor types separate. To do so, following calculations will be performed :

• Proportion of patients receiving at least 1 MTB recommendation
• Proportion of patients with at least 1 MTB recommendation that initiated the recommended treatment.
• Qualitative and quantitative descriptive analysis of treatment recommendations proposed by the MTB.
• Descriptive analysis of reasons for discordance between actual treatment and MTB recommendations.
• Proportion of patients with a time between sample pick-up and MTB report ≤28 days.
• Proportion of patients in which tumor CGP and ctDNA testing failed for technical reasons + descriptive analysis of potential reasons.
• Descriptive analysis of patient referrals between centers for participation in genotype-driven clinical trials.

Inclusion criteria

• Adult patient (minimum 18 years) able to provide written informed consent for GeNeo 2.0.
• ECOG Performance status ≤2
• Patients with advanced solid tumors or primary CNS tumors that are candidates for systemic anticancer therapy and open for enrollment in a potential downstream therapeutic trial. Enrollment in early treatment lines is strongly encouraged Tumor cohorts of breast cancer and lung cancer will be prioritized, with a minimum cap of 100 for each tumor type. Recruitment for all other tumor type cohorts will be capped at a maximum of 40 patients per tumor type. The MTB can decide on prematurely closing or extending tumor type cohorts based on treatment recommendations, clinical trial landscape or downstream treatment options. Enrollment of patients early in the advanced treatment setting will be strongly encouraged.
• Patients should have archived tissue available from a metastatic (preferred) or primary lesion biopsy for comprehensive profiling. The tissue should not be more than 2 years-old and fixed in 10% neutral buffered formalin. Tumor cell content should be >20%

Exclusion criteria

• Life expectancy of ≤12 weeks according to the local investigator
• Clinically significant hematopoietic, renal and/or hepatic dysfunction, according to the local investigator, which would make them ineligible for MGTO therapy
• Patients unwilling to comply with GeNeo 2.0 protocol data collection, data sharing and other study procedures
• Patients unwilling to provide informed consent and comply with study procedures.