Upstate Active Clinical Trials

Study Title:

PrE1702- Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +/- Chemotherapy) for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients

What is the purpose of the study? (in Layman's terms, please describe the study)

Design: Non-Interventional Study. Treating physician determines whether patient will receive single agent osimertinib or osimertinib with chemotherapy and the planned treatment is recorded at registration-To develop an infrastructure to conduct a study comparing outcomes in patients with EGFR-mutated NSCLC, not being treated in a clinical trial but receiving osimertinib +/- chemotherapy

Upstate Institutional Review Board (IRB) Number:

Pre1702

Study/Protocol ID:

2234280

Study Phase:

Registry

Patient Age Group:

Adults

Principal Investigator:

Stephen L Graziano, MD

Who is eligible?

Prior chemotherapy and/or immunotherapy is allowed ≤ 45 days of study registration. Prior osimertinib is allowed ≤ 30 days of study registration (prior treatment with any other EGFR TKI agent is not allowed).
Treatment until disease progression, unacceptable toxicity, or treating physician’s discretion as per standard of care.

What is involved if I participate?

• How long is the study?
  10Y
• Is transportation provided or reimbursed?
  No
• Is parking provided or reimbursed?
  No
• What tests and procedures are involved?
  No tests- this is a registry- All standard of care

Where will the study take place?

Cancer center-Oswego-Verona- Community hospitals

Other Information:

The design is a non-interventional (observational) study with 250 participants per exposure group (maximum accrual up to 538 total participants) not enrolled in a clinical trial who are treated with standard of care osimertinib or osimertinib + chemotherapy for NSCL

Who can I contact for more information?

Name: Raneem Alarawi
Phone: 315-464-6074
Email: [email protected]

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