Boosting outcomes after osimertinib plus chemotherapy by adding surgery or focal radiation to the primary lung tumor

A Prospective Cohort Observational Study of Local Therapy for the Primary Tumor in EGFR-Mutant Advanced Non-Small Cell Lung Cancer Following Osimertinib Plus Chemotherapy (FLAURA2 Regimen)

This trial will test whether giving surgery or focused radiation to the main lung tumor helps people with EGFR-mutant advanced non-small cell lung cancer who have disease controlled after first-line osimertinib plus chemotherapy stay progression-free longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Pusan National University Hospital (Academic / other)
• Drugs / interventions: osimertinib, chemotherapy
• Locations: 1 site (Busan)
• Trial ID: NCT07073365 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label phase II study enrolling 70 patients with EGFR-mutant stage IV NSCLC who achieved disease control after four cycles of first-line osimertinib plus platinum-based chemotherapy (FLAURA2 regimen). Participants with a residual primary lung tumor judged amenable to local therapy will receive either surgery or radiotherapy to the primary site. The primary endpoint is median progression-free survival after local therapy, with patients followed for at least 24 months after the last enrollment and total study duration up to 72 months. The trial is designed to estimate median PFS precisely and inform whether site-directed primary tumor treatment can prolong disease control in this setting.

Who should consider this trial

Good fit: Ideal candidates are adults (≥20 years) with histologically confirmed stage IV EGFR-mutant NSCLC (exon 19 deletion or L858R) who completed four cycles of first-line osimertinib plus platinum chemotherapy, have radiologic disease control, a residual primary tumor suitable for local therapy, and ECOG 0–1.

Not a fit: Patients with progressive or uncontrolled systemic disease, no residual primary tumor amenable to surgery or radiation, poor performance status, or inadequate organ function are unlikely to benefit from this local-therapy approach.

Why it matters

Potential benefit: If successful, this approach could help patients remain free from disease progression for a longer time after initial osimertinib plus chemotherapy.

How similar studies have performed: Prior trials of local consolidative therapy have shown benefit in selected NSCLC populations, but applying surgery or radiotherapy after first-line osimertinib plus chemotherapy in EGFR-mutant advanced disease is relatively new and not yet proven.

Eligibility criteria

\<Inclusion Criteria\>

Participants must meet all of the following criteria to be eligible:

1. Age ≥ 20 years at the time of consent.
2. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
3. Presence of activating EGFR mutation (exon 19 deletion or L858R).
4. Stage IV (metastatic) NSCLC at initial diagnosis.
5. Completion of four cycles of first-line osimertinib plus platinum-based chemotherapy (FLAURA2 regimen).
6. Radiologic evidence of disease control (complete response, partial response, or stable disease) after systemic therapy.
7. Residual primary lung tumor suitable for local therapy (surgery or radiotherapy), as determined by multidisciplinary evaluation.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
9. Adequate organ function based on institutional laboratory criteria.
10. Ability to understand and willingness to provide written informed consent.

\<Exclusion Criteria\>

Participants will be excluded if they meet any of the following criteria:

1. Radiologic or clinical evidence of progressive disease during first-line osimertinib-chemotherapy.
2. Extensive, unresectable metastatic disease not amenable to local therapy.
3. Untreated or clinically unstable brain metastases.
4. Known contraindications to surgery or radiotherapy.
5. Active second malignancy requiring concurrent treatment.
6. Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
7. Pregnancy or breastfeeding at the time of enrollment.

Where this trial is running

Busan

• Pusan National University Hospital — Busan, South Korea (Recruiting)

Study contacts

• Principal investigator: Mi-Hyun Kim — Pusan National University Hospital
• Study coordinator: Mi-Hyun Kim

Conditions Non-Small Cell Lung Cancer; Epidermal Growth Factor Receptor; EGFR Mutation; FLAURA2; Osimertinib; Local Therapy; Surgery; Radiotherapy