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

Phase 2Active Not RecruitingNCT06020066

Fudan University202 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

202

Conditions

Brain Metastases Non-small Cell Lung Cancer

Interventions

EGFR-TK InhibitorDRUG

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

Stereotactic radiotherapyRADIATION

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Progression-free survival

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

Time frame: Two years

Secondary Outcomes

Overall Survival

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.

Time frame: Three years

Intracranial progression-free survival

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.

Time frame: Two years

Health-related quality of life per QLQ-C30

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

Time frame: Two years

Health-related quality of life per QLQ-LC13

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

Time frame: Two years

Percentage of Participants With Adverse Events

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

Time frame: Two years

Data from ClinicalTrials.gov

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