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Recruiting NCT07073365

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

Phase II Interventional Non-Small Cell Lung Cancer Epidermal Growth Factor Receptor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Local Therapy (Surgery or Radiotherapy).
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer, Epidermal Growth Factor Receptor. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Detailed description

This prospective, single-arm, multicenter observational study is designed to estimate the median progression-free survival (PFS) in patients with EGFR-mutant advanced non-small cell lung cancer (NSCLC) who receive salvage local treatment after achieving disease control with first-line osimertinib plus chemotherapy. A total of 70 patients will be enrolled. The primary endpoint is median PFS, and the sample size was calculated to ensure that the 95% confidence interval around the estimated median has a width of no more than ±3 months, using Greenwood's approximation. Patients will be followed for a minimum of 24 months after the last enrollment, with an overall study duration of up to 72 months.

Interventions

  • Other 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.

Primary outcome measures

  • Median progression-free survival (PFS) [Time frame: Up to 60 months (through June 30, 2030; patients followed for ≥24 months after last enrollment)]
Secondary outcome measures (3)
  • Overall survival (OS) [Time frame: Up to 72 months (through June 30, 2031)]
  • Local Control Rate [Time frame: Up to 60 months (through June 30, 2030)]
  • Adverse events (AEs) [Time frame: Up to 60 months (through June 30, 2030)]

Eligibility criteria

<Inclusion Criteria>

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 Criteria>

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Pusan National University Hospital — Busan

Publications

  • Kim 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

Identifiers

NCT: NCT07073365 · PNU-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗