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

Fudan University61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NSCLC Stage IV EGFR Activating Mutation

Interventions

3rd generation EGFR-TKIDRUG

Osimertinib will be administered orally at the dose of 80 mg once daily.

Consolidative SRTRADIATION

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration. * The patient has a diagnosis of American Joint Committee on Cancer (AJCC) 8th Edition stage IV NSCLC. * The patient receives 3rd generation EGFR-TKI in the first line setting. * The patient is ≥18 years of age and ≤75 years of age at the time of screening. * The patient's Karnofsky performance score (KPS) is ≥70 at study entry. * The patient has adequate baseline tumor assessment before initiation of 3rd generation EGFR-TKI. * The patient has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. * The patient presents with a residual "oligometastatic" state after 3rd generation EGFR-TKI therapy that would be amenable to consolidative SRT in the opinion of the investigator. * The patient has signed informed consent. * EGFR Exon19 deletion or Exon21 L858R mutation Exclusion Criteria: * History of another malignancy or concurrent malignancy. Patients with cervical carcinoma in situ or adequately treated basal cell carcinoma who have been disease free for \> 5 years are eligible. * The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding. * Patients with uncontrolled epilepsy, mental disorders, drug abuse, or social condition that may affect compliance or ability to sign a written informed consent in the opinion of the investigator. * Patients with residual metastatic disease after 3rd generation EGFR-TKI therapy that is deemed not amenable to consolidative SRT.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Outcomes

Primary Outcomes

Progression Free Survival

PFS was measured from the date of enrollment to the date of disease progression as defined by Response Evaluation Criteria in Solid Tumor (RECIST) Version 1.1 or death due to any cause, whichever occurred first. For patients whose disease did not progress, PFS was evaluated by censoring patients at their most recent imaging.

Time frame: Two years

Secondary Outcomes

Percentage of Participants With Adverse Events

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

Time frame: Two years

Overall Survival

OS was defined as the time from the date of enrollment 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: Two years

Data from ClinicalTrials.gov

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