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

NCT ID: NCT07073365

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2031-06-30

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.

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.

Conditions

Non-Small Cell Lung Cancer; Epidermal Growth Factor Receptor

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Local Therapy Arm

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.

Group Type: EXPERIMENTAL

Local Therapy (Surgery or Radiotherapy)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pusan National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mi-Hyun Kim

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Hospital

Locations

Pusan National University Hospital

Busan, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Mi-Hyun Kim

Role: CONTACT

Phone: 82-51-240-7845

Email: mihyunkim@pusan.ac.kr

Soo Han Kim

Role: CONTACT

Phone: 82-51-240-7845

Email: kshyjt1004@gmail.com

References

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.

Reference Type: DERIVED

PMID: 41234591 (View on PubMed)

Other Identifiers

PNU-002

Identifier Type: -

Identifier Source: org_study_id