Response of Bone Metastasis to Tyrosine Kinase Inhibitors in Non-Small Cell Lung Cancers with Actionable Driver Mutations

Inclusion Criteria

• Provision to sign and date the consent form
• Stated willingness to comply with all study procedures and be available for the duration of the study
• Be a male or female aged 18-100 years
• Pathologically confirmed non-small cell lung cancer
• Molecular testing through a Clinical Laboratory Improvement Act (CLIA)-validated next generation sequencing (NGS) assay. This can be done using either tissue based samples or blood-based samples (circulating tumor deoxyribonucleic acid [ctDNA])
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• Participant must receive standard of care therapy per NCCN guidelines * Patients with a known oncogene driver mutation will receive tyrosine kinase inhibitors that are appropriate for their mutation * Patients without an actionable driver mutation will receive standard of care systemic therapy options, per the discretion of the treating investigator, that include: ** Platinum doublet chemotherapy ** Platinum doublet chemotherapy with bevacizumab ** Platinum doublet chemotherapy with an immune checkpoint inhibitor ** Immune checkpoint inhibitor alone
• Patients who will be treated with an osteoclast inhibitor must receive dental clearance prior to starting treatment * Exceptions to this requirement may be allowed with documented approval by the Treating Investigator when dental clearance is not clinically indicated (e.g. dentures)
• Bone metastases must be detected through radiographic imaging prior to enrollment on this study

Exclusion Criteria

• Actionable driver mutation NSCLC patient who has been on anti-bone resorptive therapy * Excluded anti-bone resorptive therapy includes: zolendronic acid, pamidronate, alendronate, denosumab or any medication that acts as an osteoclast inhibitor
• Have any condition or illness that, in the opinion of the investigator, would compromise participant safety or interfere with evaluation while on standard of care treatments for the NSCLC
• Patients with actionable driver mutation who received TKI in past or currently on TKI prior to screening
• Bone metastases that have received prior radiotherapy unless unequivocal progression has occurred since radiation therapy