Local Therapy After FLAURA2 in EGFR-mutant NSCLC (PNU-0002)

Not Applicable

Recruiting

• Conditions: Non-Small Cell Lung Cancer; Epidermal Growth Factor Receptor

• Registration Number: NCT07073365
• Lead Sponsor: Pusan National University Hospital

Brief Summary

This is a single-arm, open-label, phase II study evaluating the clinical outcomes of local therapy (surgery or radiotherapy) to the primary tumor in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) who have achieved disease control following first-line treatment with the FLAURA2 regimen (osimertinib plus platinum-based chemotherapy). The primary objective is to assess 1-year progression-free survival (PFS) after local therapy.

Detailed Description

This prospective, single-center, clinical trial aims to investigate the efficacy and safety of local therapy to the primary lung tumor in patients with EGFR mutation-positive advanced NSCLC who show a good response to first-line systemic therapy with osimertinib combined with platinum and pemetrexed (FLAURA2 regimen). Eligible patients who achieve complete response, partial response, or stable disease at the primary site after systemic therapy and meet predefined criteria will undergo surgery or radiotherapy to the primary lesion. The study will follow patients for progression-free survival, overall survival, and local control rate, as well as safety outcomes related to local therapy. No randomization or blinding is applied.

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Primary Completion: 2029-06-30
• Study Completion: 2030-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) rate	12 months from the date of local therapy	The proportion of patients who remain alive without radiologic or clinical disease progression 12 months after receiving local therapy (surgery or radiotherapy) following first-line osimertinib plus chemotherapy.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	24 months from the date of local therapy	Time from the initiation of local therapy to death from any cause. Patients still alive will be censored at the date of last follow-up.
Local Control Rate	12 months from the date of local therapy	Proportion of patients without radiologic progression at the primary tumor site after local therapy.
Adverse Events (AEs)	12 months from the date of local therapy	Incidence and severity of treatment-related adverse events will be recorded and graded according to CTCAE v5.0.

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of