NCT03586453

Osimertinib In EGFR Mutant Lung Cancer

A Phase II Study of Osimertinib With On-study and Post-progression Biopsy in the First Line Treatment of EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a targeted therapy as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR mutation. The names of the study drug involved in this study is: \- Osimertinib (Tagrisso)

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. This research study is studying a targeted therapy as a possible treatment for Non-Small Cell Lung Cancer (NSCLC) with an EGFR (epidermal growth factor receptor) genetic mutation. The EGFR gene produces a protein that helps cells divide. Specific changes or a mutation in the genetic information causes abnormal cell division and can lead to lung cancer. Patients who have NSCLC with an EGFR gene mutation can be treated by drugs called EGFR tyrosine kinase inhibitors (EGFR TKIs). They may stop (or "inhibit") the effect of the mutation in the EGFR gene. \- Osimertinib has been approved by the FDA (the U.S. Food and Drug Administration) for this disease.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Osimertinib	Patients who fulfill eligibility criteria will be entered into the trial to receive Osimertinib. After the screening procedures confirm participation in the research study: * Osimertinib: Oral, Daily 28 day cycle. * Radiographic assessment: every 2 cycles for first 6 months and then every 3 cycles until disease progression. * Tumor biopsy between C4 and C8 and at disease progression

Timeline

• Start date: 2018-08-13
• Primary completion: 2027-02-28
• Completion: 2028-03-01
• First posted: 2018-07-13
• Last updated: 2026-04-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study