SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Prior treatment

• History of prior solid malignancy or hematological malignancy within five years of enrollment
• Unable to collect a baseline blood sample during a SOC venipuncture, and prior to starting SOC regimen

Other

• Any potential participant who meets and of the following criteria at the time of initial enrollment will be excluded from participating in the study:
• Life expectancy ≤12 weeks
• Is participating in a clinical trial or another observational study that is evaluating the performance of another genomic test for detecting/predicting clinical response/progression

• Each participant must satisfy all the following criteria to be enrolled in the study:
• Age ≥18 years old
• Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study
• Patient is either treatment naive and has not yet commenced first line SOC therapy OR patient has completed first line SOC therapy and will commence second line of SOC therapy
• Able to understand, and capable of providing written consent to participate in the study
• Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent
• Are willing to provide blood samples at enrollment and at subsequent clinical visits
• Have a histologically confirmed Index cancer that qualifies for inclusion, defined as:
  • Cohort 1: Unresectable Stage III/IV NSCLC (\~125)
  • Cohort 2: Stage IV Colorectal (\~125)
  • Cohort 3: Unresectable Stage III/IV Breast - HR+ HER2- (\~55)
  • Cohort 4: Unresectable Stage III/IV Breast - HR- HER2+ (\~55)
  • Cohort 5: Unresectable Stage III/IV Breast - HR+ HER2+ (\~55)
  • Cohort 6: Unresectable Stage III/IV Breast - Triple Negative (\~55) Determination of stage for eligibility assessment and enrollment should be based on clinical or pathologic stage.