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

NCT04764214 | Completed Phase 2

• 1 other identifier: 2020-NSCLCSBRT-1
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC Stage IV; EGFR Activating Mutation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Participants With Adverse Events

  Two years

• Overall Survival

  Two years

Study Arms (1)

3rd generation EGFR-TKI+ SRT

EXPERIMENTAL

Patients were treated with the intent to ablate all residual disease with consolidative SRT. EGFR-TKI treatment was continued during and after consolidative SRT until disease progression or intolerable toxicity.

Drug: 3rd generation EGFR-TKI; Radiation: Consolidative SRT

Interventions

3rd generation EGFR-TKI DRUG

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

Also known as: Osimertinib

3rd generation EGFR-TKI+ SRT

Consolidative SRT RADIATION

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.

3rd generation EGFR-TKI+ SRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

Related Publications (1)

• Zhou Y, Peng L, Liang F, Chu L, Chu X, Yang X, Zhang J, Guo T, Jiang S, Pang Y, Wang Z, Zhang L, Ni J, Zhu Z. Safety and efficacy of consolidative stereotactic radiotherapy for oligo-residual EGFR-mutant non-small cell lung cancer after first-line third-generation EGFR-tyrosine kinase inhibitors: a single-arm, phase 2 trial. EClinicalMedicine. 2024 Sep 26;76:102853. doi: 10.1016/j.eclinm.2024.102853. eCollection 2024 Oct.

  PMID: 39398493 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhengfei Zhu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 21, 2021
• Study Start: March 1, 2021
• Primary Completion: March 31, 2023
• Study Completion: July 20, 2023
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

CN (1)