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NCT Number: NCT06020066

SRS for NSCLC With Oligo-residual Intracranial Disease After First-line 3rd Generation EGFR-TKI

Despite the impressive response rate to third-generation EGFR-TKIs, resistance inevitably develops in most patients. Stereotactic radiotherapy plays a growing role in the management of patients with brain metastasis. This study aims to evaluate the efficacy and safety of stereotactic radiotherapy for oligo-residual intracranial disease after first-line third-generation EGFR Inhibitors.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Non-small Cell Lung Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200030, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically confirmed non-small cell lung cancer;
  • Clinical stage IV (AJCC, 8th edition, 2017);
  • EGFR mutations: EGFR L858R, EGFR exon 19 deletion;
  • Age ≥18 years;
  • KPS score ≥70;
  • Brain metastasis at the time of diagnosis;
  • Complete baseline imaging assessment of metastatic lesions, including enhanced MRI for brain;
  • Receiving first-line treatment with third-generation EGFR inhibitors;
  • After 3-6 months of third-generation EGFR inhibitor treatment, imaging review indicates no progression of extracranial lesions, and brain lesions are evaluated by thin-layer (1mm layer) enhanced MRI, meeting the following criteria:
  • No more than 10 remaining brain lesions;
  • The maximum diameter of the remaining brain lesions does not exceed 3cm;
  • At least one remaining brain lesion has a diameter greater than 5mm;
  • After evaluation by the researcher, all remaining brain lesions are suitable for stereotactic radiotherapy.
  • Patient informed consent.

Exclusion criteria

  • Poor compliance with the study protocol in the investigator's opinion;
  • Patients withdrew their informed consent and requested to withdraw from the study;
  • Patients were unable to receive regular doses of third-generation EGFR inhibitors due to other underlying conditions, viral side effects, economic factors, etc. (e.g., continuous discontinuation for more than 1 week, cumulative discontinuation for more than 2 weeks).
  • Patients did not follow the protocol for follow-up visits as required by this study.

Treatment and study plan

EGFR-TK Inhibitor

Drug

Patients will receive EGFR-TKI until confirmed progression or unacceptable toxicity.

Stereotactic radiotherapy

Radiation

Patients with oligo-residual intracranial disease after treatment with EGFR-TKI will be treated with SRS of all intracranial lesions. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist.

Primary outcomes

  1. Progression-free survival

    Time frame: Two years

    PFS was measured from the date of randomization to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death

Secondary outcomes

  1. Overall Survival

    Time frame: Three years

    OS was defined as the time from the date of randomization until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.

  2. Intracranial progression-free survival

    Time frame: Two years

    iPFS was defined as the time from the start of randomization to the occurrence of intracranial disease progression or death. If the subject first experiences extracranial disease progression (without concurrent intracranial disease progression), the date of first extracranial disease progression will be used as the cut-off date. For patients who have not progressed at the time of analysis, the date of their last contact will be used as the cut-off date.

  3. Health-related quality of life per QLQ-C30

    Time frame: Two years

    Health-related quality of life was evaluated using the QLQ-C30 questionnaires to assess health-related quality of life.

  4. Health-related quality of life per QLQ-LC13

    Time frame: Two years

    Health-related quality of life was evaluated using the QLQ-LC13 questionnaires to assess health-related quality of life.

  5. Percentage of Participants With Adverse Events

    Time frame: Two years

    Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Stereotactic Radiotherapy for Non-small Cell Lung Cancer With Oligo-residual Intracranial Disease After First-line Third-generation EGFR Inhibitors: a Multicenter, Randomized Clinical Trial.

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Aug 31, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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