Upstate Active Clinical Trials

Study Title:

PrECOG Protocol Number: 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)

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.

Upstate Institutional Review Board (IRB) Number:

2234280

Study/Protocol ID:

2234280/ Pre1702

Study Phase:

Registry

Patient Age Group:

Adults

Principal Investigator:

Stephen L Graziano, MD

Who is eligible?

For centers that have EA5182 active, this study will also register participants that are candidates for treatment but were not eligible or not interested in participation in EA5182: Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC).

What is involved if I participate?

• How long is the study?
  10Years
• Is transportation provided or reimbursed?
  No
• Is parking provided or reimbursed?
  No
• What tests and procedures are involved?
  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. No procedures or tests this is a registry

Where will the study take place?

Upstate down town cancer center, Verona, Oswego, Community cancer centers

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 NSCLC.
Data collection is designed to record important information on patient demographic and clinical history data, appropriate laboratory variables, and sites of disease at baseline, then subsequently much less information except as it may bear on decision-making and endpoint definition. Treatment information and toxicities will be collected.
When available, we will record baseline next generation sequencing (tumor, cytology, or blood) and record repeat genomic testing at time of progression (again, if available) to identify putative resistance mutations.
Defining date of progression is the key endpoint after patient has commenced therapy, and we will be basing assessment of PFS date from physician notes. We will describe sites of disease at progression, as well as toxicity (moderate, severe, life-threatening events or death) information, and follow patients for survival.
Patients will be selected for the study from clinical community and academic practice sites across the United States based on the checklist below. Information to support each item must be found in the patient record.

Who can I contact for more information?

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

Return to Previous Page || Search Again