NCT04591002

Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)

A Phase II, Study of Osimertinib to Suppress the Progression of Remaining Ground-glass Opacity Nodule (GGN) in Other Lobes After Curative Resection for Actionable EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study designed to assess the efficacy of osimertinib (80 mg, orally, once daily) to suppress the progression of remaining GGN(s) in other lobes following surgical resection for actionable EGFR mutation-positive stage I lung adenocarcinoma.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib 80 MG	Osimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR-TKI sensitising and resistance mutations in NSCLC with a significant selectivity margin over wild-type EGFR. Osimertinib will be administered orally as one 80 mg tablet once a day (1 cycle is 28 days). Cycles are repeated until disease progression, unacceptable toxicity, or until 1 year after the initiation of osimertinib administration.

Timeline

• Start date: 2022-07-26
• Primary completion: 2025-11-20
• Completion: 2028-10-30
• First posted: 2020-10-19
• Last updated: 2025-06-26

Locations

2 sites across 1 country: South Korea