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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic body radiotherapy (SBRT) for patients with residual oligometastases of NSCLC after 3rd generation EGFR-TKIs.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Osimertinib

Criteria

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 after progression on 1st or 2nd generation EGFR-TKI with either tissue or liquid biopsy-confirmed acquired T790M mutation.

• 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 SBRT in the opinion of the investigator.

• The patient has signed informed consent.

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 confirmed to be negative for T790M mutation or patients in whom the T790M status is not evaluated after progression on 1st or 2nd generation EGFR-TKI.

• 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 SBRT.