EGFR Activating Mutation, NSCLC Stage IV
Conditions
Brief 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.
Interventions
DRUG3rd generation EGFR-TKI
Osimertinib will be administered orally at the dose of 80 mg once daily.
RADIATIONConsolidative 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
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | Two years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events | Two years | Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0. |
| Overall Survival | Two years | 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. |
Countries
China
Outcome results
None listed