Development of a Cell Free DNA Assay as a Biomarker for Predicting Early Non-response to Therapy in Metastatic Cancer

Inclusion Criteria

• •Age ≥ 18 years.
• •Documented stage IV NSCLC, SCLC, BC or CRC (can be new diagnosis, persistent or recurrent disease):
• •BC patients who meet the following criteria:
• •ER+/HER2- and has failed hormone therapy within the last two years, or ER+/HER2+ or, ER-/HER+ or, HER2-/ER-/PR- (TNBC), and Has ≥ 1 measurable non- bone lesion as measured per RECIST or, If bone only disease, has two or more measurable (\> 1 cm by RECIST) predominantly lytic bone lesions
• •Planned initiation of new systemic first- or second-line treatment or subsequent therapies with chemotherapy, immunotherapy, targeted therapy or combination thereof. Or continuation of the current line of therapy after RECIST/iRECIST evaluation which coincides with end of the cycle of therapy and prior to initiation of the next cycle of therapy.
• •Imaging to determine RECIST and/or iRECIST criteria:
• •If baseline blood draw is planned prior to first cycle of a line (1st, 2nd, 3rd etc) of therapy, measurable disease with CT or MRI or PET/CT monitoring should be completed within 4 weeks prior to baseline blood draw.
• •If baseline test is performed at the completion of a cycle of therapy, CT or MRI or PET/CT monitoring should be completed to coincide with end of cycle of therapy and prior to baseline blood draw.
• •Planned CT or MRI or PET/CT monitoring for treatment response completed within 8-12 weeks of start of treatment.
• •Willing and able to donate up to 30mL of blood at each blood draw. Willing and able to provide informed consent.