Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epidermal Growth Factor Receptor | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Local Therapy (Surgery or Radiotherapy) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Local Therapy Arm
- description
- Patients with EGFR-mutant advanced non-small cell lung cancer who achieve disease control after first-line osimertinib plus chemotherapy (FLAURA2 regimen) will receive local therapy (surgery or radiotherapy) to the primary tumor. The study will evaluate clinical outcomes including progression-free survival, overall survival, and treatment-related toxicity.
- interventionNames
- Other: Local Therapy (Surgery or Radiotherapy)
Primary outcomes (1)
- measure
- Median progression-free survival (PFS)
- timeFrame
- Up to 60 months (through June 30, 2030; patients followed for ≥24 months after last enrollment)
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
\<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.
References
Publications (1)
- DERIVEDKim MH, Seong H, Kim SH, Eom JS. Local consolidative therapy for the primary tumor in EGFR-mutant advanced non-small cell lung cancer following osimertinib plus chemotherapy: a protocol for a single-arm, open-label, phase 2 trial. Transl Lung Cancer Res. 2025 Oct 31;14(10):4666-4674. doi: 10.21037/tlcr-2025-922. Epub 2025 Oct 29. PMID 41234591