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

NCT04764214 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-08-19

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhengfei Zhu, MD · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-03-31
Completion
2023-07-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04764214 on ClinicalTrials.gov