NCT06538038

Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC Patients

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 538 (estimated)
• Sponsor: PrECOG, LLC. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens.

Detailed description

This study tests the feasibility of using real-world data collection through the recruitment of well-characterized patients into a registry, spanning academic and community practice sites to determine patient outcomes in all-comers. The scientific community would further benefit from a greater understanding of the safety and effectiveness of newly approved therapies prescribed in routine clinical practice. Non-interventional (observational) study with 250 participants per exposure group (maximum accrual up to 538 total participants) comparing outcomes in patients with EGFR-mutated NSCLC, not being treated in a clinical trial but receiving standard of care osimertinib +/- chemotherapy. The treating physician determines whether a patient will receive standard of care single agent osimertinib or osimertinib with chemotherapy and the planned treatment is recorded at registration. Clinical/Imaging assessments will be per the treating physician.

Conditions

• Non Small Cell Lung Cancer
• Epidermal Growth Factor Receptor Gene Mutation
• Stage III Lung Cancer
• Stage IV Lung Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib	Single agent Osimertinib by mouth once daily. Dosing and administration of osimertinib will be administered as per routine standard of care per the package insert or per institutional guidelines.
DRUG	Osimertinib + Chemotherapy	Osimertinib by mouth once daily + Chemotherapy. Chemotherapy choice will be per treating physician. Dosing and administration of osimertinib +/- chemotherapy agents will be administered as per routine standard of care per the package insert or per institutional guidelines.

Timeline

• Start date: 2024-09-17
• Primary completion: 2028-08-01
• Completion: 2029-08-01
• First posted: 2024-08-05
• Last updated: 2026-03-27

Locations

146 sites across 1 country: United States

Regulatory

• FDA-regulated drug study