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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

\<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 it's running

• Pusan National University Hospital
  Busan, South Korea Recruiting

Study contacts

• Principal investigator: Mi-Hyun Kim — Pusan National University Hospital
• Study coordinator: Mi-Hyun Kim
• Email: mihyunkim@pusan.ac.kr
• Phone: 82-51-240-7845

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.