Actively Recruiting
Bolstering Outcomes After Induction With Osimertinib Plus Chemotherapy Through Optimized Site-Directed Primary Tumor Therapy (BOOST Trial)
Led by Pusan National University Hospital · Updated on 2025-12-30
70
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bolstering Outcomes After Induction With Osimertinib Plus Chemotherapy Through Optimized Site-Directed Primary Tumor Therapy (BOOST Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older at 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
You will not qualify if you...
- 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 would interfere with study participation or interpretation of results
- Pregnancy or breastfeeding at the time of enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Pusan National University Hospital
Busan, South Korea
Actively Recruiting
Research Team
M
Mi-Hyun Kim
CONTACT
S
Soo Han Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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