Bolstering Outcomes After Induction With Osimertinib Plus Chemotherapy Through Optimized Site-Dir… (NCT07073365) | Clinical Trial Compass
RecruitingPhase 2
Bolstering Outcomes After Induction With Osimertinib Plus Chemotherapy Through Optimized Site-Directed Primary Tumor Therapy (BOOST Trial)
South Korea70 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range20 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 20 years at the time of consent.
✓. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC).
✓. Presence of activating EGFR mutation (exon 19 deletion or L858R).
✓. Stage IV (metastatic) NSCLC at initial diagnosis.
✓. Completion of four cycles of first-line osimertinib plus platinum-based chemotherapy (FLAURA2 regimen).
✓. Radiologic evidence of disease control (complete response, partial response, or stable disease) after systemic therapy.
✓. Residual primary lung tumor suitable for local therapy (surgery or radiotherapy), as determined by multidisciplinary evaluation.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion criteria
✕. Radiologic or clinical evidence of progressive disease during first-line osimertinib-chemotherapy.
✕. Extensive, unresectable metastatic disease not amenable to local therapy.
✕. Untreated or clinically unstable brain metastases.
✕. Known contraindications to surgery or radiotherapy.
✕. Active second malignancy requiring concurrent treatment.
What they're measuring
1
Median progression-free survival (PFS)
Timeframe: Up to 60 months (through June 30, 2030; patients followed for ≥24 months after last enrollment)