SIBYL: obServation of Therapy Response With lIquid BiopsY evaLuation

Inclusion Criteria

• •Each participant must satisfy all the following criteria to be enrolled in the study:
• •1. Age ≥18 years old
• •2. Are treated with systemic therapy and/or oral SOC regimen at the site of enrollment during entirety of study
• •3. 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
• •4. Able to understand, and capable of providing written consent to participate in the study
• •5. Are willing to have de-identified clinical data shared with investigators at regular intervals outlined in the study protocol and informed consent
• •6. Are willing to provide blood samples at enrollment and at subsequent clinical visits
• •7. 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.