NCT07295821

Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study

Phase II, Single-arm Multicenter Study of Osimertinib Induction Before Radiotherapy and Maintenance in Chemo-ineligible or Refusing Patients With Stage III, Unresectable NSCLC and EGFR Mutation-positive Tumors

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).

Detailed description

Study details include: * The study duration will be approximately 13 months for recruitment and 2 years of follow up from the last patient's initiation into the study. * The induction treatment with osimertinib will be up to12 weeks, followed by 6 weeks of RT treatment and osimertinib maintenance treatment until disease progression or death. * The visit frequency will be once after 12 weeks during the induction treatment period, every 3 weeks during the RT period (daily visits for RT), and every 12 weeks during the osimertinib maintenance treatment period.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib	80 mg Osimertinib QD

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-05-30
• Completion: 2029-05-30
• First posted: 2025-12-22
• Last updated: 2026-04-08

Locations

20 sites across 1 country: China