NCT04764214

SRT for Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs

An Open-label, Single-Arm, Phase 2 Trial of Stereotactic Radiotherapy for Patients With Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic radiotherapy (SRT) for patients with oligo-residual NSCLC after 3rd generation EGFR-TKIs.

Conditions

• NSCLC Stage IV
• EGFR Activating Mutation

Interventions

Type	Name	Description
DRUG	3rd generation EGFR-TKI	Osimertinib will be administered orally at the dose of 80 mg once daily.
RADIATION	Consolidative SRT	Patients who possess oligoresidual disease after 3rd generation EGFR-TKI therapy will be treated with the intent to ablate all residual disease with consolidative SRT. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist. TKI will be continued during and after consolidative SRT until disease progression or intolerable toxicity.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-03-31
• Completion: 2023-07-20
• First posted: 2021-02-21
• Last updated: 2024-08-19

Locations

1 site across 1 country: China