Early Rebiopsy to Identify Biomarkers of Tumor Cell Survival Following EGFR, ALK, ROS1 or BRAF TKI Therapy

Inclusion criteria

• Targetable Oncogene - Biopsy Cohort (includes blood draw)
• Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapies (per current NCCN guidelines)
• Aged 18 years or older
• ECOG 0-2
• Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)
• No prior systemic therapy for locally advanced or metastatic disease.
• Planned treatment with targeted therapy specific to the oncogene driver mutation.
• Patients must have at least one site of measurable disease ≥ 2cm.
• Primary disease site or site of metastatic disease must be amenable to biopsy.
• Patients must have the ability to understand and willingness to sign an informed consent document.
• Targetable Oncogene - Blood Draw Only Cohort
• Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapy (per NCCN guidelines)
• Aged 18 years or older
• ECOG 0-2
• Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)
• No prior systemic therapy or radiotherapy for metastatic lung cancer (surgery alone permitted)
• Planned treatment with targeted therapy specific to the oncogene driver mutation.
• Declines repeat biopsy option or does not have tumor site amenable to biopsy.
• Patients must have the ability to understand and willingness to sign an informed consent document.
• Immunotherapy Cohort - Blood Draw Only
• Have a histologically confirmed diagnosis of locally advanced or stage IV NSCLC without a treatable activating mutation that would be amenable to targeted therapy AND planned first line treatment with immunotherapy or chemotherapy plus immunotherapy.
• Aged 18 years or older
• ECOG 0-2
• No prior systemic therapy or radiation therapy for lung cancer (surgery alone permitted)
• Patients must have the ability to understand and willingness to sign an informed consent document.

Exclusion criteria

• Targetable Oncogene - Biopsy Cohort (includes blood draw)
• Concurrent health problem which would preclude tissue biopsy (e.g. hemophilia or other bleeding predisposition).
• Patients whose only biopsy source would involve sampling an anatomic area that carries an unacceptably high procedural risk (e.g. pericardium or kidney) as deemed by the treating physician or by a proceduralist performing the biopsy.
• Patients whose only biopsy source involves a sample that may not be evaluable due to insufficient genomic material (such as cerebrospinal or ascitic fluid) as deemed by the treating physician. .
• Targetable Oncogene Cohort and Immunotherapy Cohort - Blood Draw Only
• Planned follow up on therapy outside of the University of Colorado Health System
• Unwillingness to allow for residual clinical biopsy specimens to be utilized in this study.