Bolstering Outcomes After Induction With Osimertinib Plus Chemotherapy Through Optimized Site-Directed Primary Tumor Therapy (BOOST Trial)
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)
Pusan National University Hospital
70 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria11
- Participants must meet all of the following criteria to be eligible:
- 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.
- Adequate organ function based on institutional laboratory criteria.
- Ability to understand and willingness to provide written informed consent.
Exclusion Criteria8
- Participants will be excluded if they meet any of the following 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.
- Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
- Pregnancy or breastfeeding at the time of enrollment.
Interventions
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.
Locations(1)
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NCT07073365