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

NSCLC Stage IV Clinical Trial

Official title:

An Open-label, Single-Arm, Phase 2 Trial of Stereotactic Radiotherapy for Patients With Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04764214
• Other study ID #: 2020-NSCLCSBRT-1
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: July 20, 2023

Study information

• Verified date: February 2024
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 20, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Activating Mutation
• NSCLC Stage IV

Intervention

Drug:
• 3rd generation EGFR-TKI
Osimertinib will be administered orally at the dose of 80 mg once daily.

Radiation:
• Consolidative 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.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Two years
Secondary	Percentage of Participants With Adverse Events	Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.	Two years
Secondary	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.	Two years