Ireland
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Recruiting Phase 2

Bolstering Outcomes After Induction With Osimertinib Plus Chemotherapy Through Optimized Site-Directed Primary Tumor Therapy (BOOST Trial)

NCT07073365 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 2
Started
2025-07-01
Last updated
2025-12-30

Condition(s) studied

Non-Small Cell Lung CancerEpidermal Growth Factor Receptor

Investigational drug(s) / intervention(s)

Local Therapy (Surgery or Radiotherapy)

Local Therapy (Surgery or Radiotherapy): Patients will receive local therapy, either surgical resection or radiotherapy, to the primary lung tumor following disease control after first-line treatment with osimertinib plus platinum-based chemotherapy (FLAURA2 regimen). The specific modality (surgery or radiotherapy) will be determined based on tumor characteristics, patient condition, and multidisciplinary team assessment.

Study 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 the median progression-free survival (PFS) after local therapy.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
\<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.

Primary outcome measure(s)

  • Median progression-free survival (PFS) — Up to 60 months (through June 30, 2030; patients followed for ≥24 months after last enrollment)
    Time from the initiation of local therapy to the date of radiographic or clinical disease progression or death from any cause, whichever occurs first. Median PFS will be estimated using the Kaplan-Meier method.

Trial sites (1)

FacilityCityRegionStatus
Pusan National University Hospital Busan South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07073365 on ClinicalTrials.gov ↗ ← All trials in South Korea