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

NCT07073365 | Recruiting Phase 2

• 1 other identifier: PNU-002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Small Cell Lung Cancer; Epidermal Growth Factor Receptor

Keywords

Non-Small Cell Lung Cancer; EGFR Mutation; FLAURA2; Osimertinib; Local Therapy; Surgery; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Median progression-free survival (PFS)

  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.

  Up to 60 months (through June 30, 2030; patients followed for ≥24 months after last enrollment)

Secondary Outcomes (3)

• Overall survival (OS)

  Up to 72 months (through June 30, 2031)

• Local Control Rate

  Up to 60 months (through June 30, 2030)

• Adverse events (AEs)

  Up to 60 months (through June 30, 2030)

Study Arms (1)

Local Therapy Arm

EXPERIMENTAL

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.

Other: Local Therapy (Surgery or Radiotherapy)

Interventions

Local Therapy (Surgery or Radiotherapy) OTHER

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.

Local Therapy Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, South Korea

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mi-Hyun Kim

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mi-Hyun Kim

CONTACT

82-51-240-7845; mihyunkim@pusan.ac.kr

Soo Han Kim

CONTACT

82-51-240-7845; kshyjt1004@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm study with local therapy after systemic treatment.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

KR (1)