NCT07073365 Bolstering Outcomes After Induction With Osimertinib Plus Chemotherapy Through Optimized Site-Directed Primary Tumor Therapy (BOOST Trial)
| NCT ID | NCT07073365 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pusan National University Hospital |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2030-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2025-07-01 with a primary completion date of 2030-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Mi-Hyun Kim
PRINCIPAL INVESTIGATOR
Pusan National University Hospital
Frequently Asked Questions
Who can join the NCT07073365 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07073365 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07073365 currently recruiting?
Yes, NCT07073365 is actively recruiting participants. Contact the research team at mihyunkim@pusan.ac.kr for enrollment information.
Where is the NCT07073365 trial being conducted?
This trial is being conducted at Busan, South Korea.
Who is sponsoring the NCT07073365 clinical trial?
NCT07073365 is sponsored by Pusan National University Hospital. The principal investigator is Mi-Hyun Kim at Pusan National University Hospital. The trial plans to enroll 70 participants.
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