Third-generation EGFR-TKI Treatment in Metastatic EGFR-mutant NSCLC

NCT06613633 | Completed

• 1 other identifier: 2018-NSCLCSIB
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this observational study is to explore the feasibility of stereotactic radiotherapy (SRT) as consolidation therapy for patients with advanced non-small-cell lung cancer who were treated with third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The investigators plan to explore the time to achieve the best response after EGFR-TKI treatment, the characteristics of the distribution of lesions when the best response is achieved, the feasibility of SRT when the best response is achieved, and the phenotype of disease progression after EGFR-TKI resistance. In summary, this study will provide critical information for exploring the feasibility and optimal design of SRT as consolidation therapy for advanced NSCLC patients treated with third-generation EGFR-TKI, which will further promote the optimization of comprehensive treatment for EGFR-mutant advanced NSCLC.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer); Third-generation TKI

Keywords

NSCLC; EGFR

Outcome Measures

Primary Outcomes (1)

• Time to Best Response

  The time from the first day of third-generation EGFR-TKI treatment to the point at which the smallest tumor burden is observed on imaging studies.

  5 years

Secondary Outcomes (2)

• Distribution of Tumor Lesions at Best Response

  5 years

• Phenotypes of Disease Progression After Third-Generation EGFR-TKI Resistance

  5 years

Study Arms (1)

third-generation EGFR-TKI monotherapy

Drug: third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib)

Interventions

third-generation EGFR-TKI (Osimertinib, Almonertinib or Furmonertinib) DRUG

Patients with advanced EGFR-mutated NSCLC who met the inclusion criteria and received third-generation EGFR-TKI (monotherapy or combined with brain radiotherapy)

third-generation EGFR-TKI monotherapy

Eligibility Criteria

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

Study Population

Advanced EGFR-mutant NSCLC patients receiving third-generation EGFR-TKIs are enrolled

You may qualify if:

• Pathologically confirmed non-small cell lung cancer;
• clinical stage IV (AJCC, 8th edition, 2017);
• EGFR sensitizing mutations (L858R or 19del);
• age≥18 years old;
• KPS score≥70;
• complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment;
• received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy);
• willing to cooperate with the follow-up after third-generation EGFR-TKI treatment;
• informed consent of the patient.

You may not qualify if:

• Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);
• Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
• Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.;
• patients without EGFR sensitive mutations or with unknown EGFR mutation status.
• Withdrawal criteria
• The investigators considered that the patients had poor adherence to the study protocol.
• The patient withdrew informed consent and asked to withdraw.
• There was any safety reason (adverse event) considered by the investigator;
• Due to other underlying diseases, side effects, economic factors, and other reasons, patients did not receive regular doses of third-generation EGFR-TKI (continuous withdrawal time more than 1 week, cumulative withdrawal time more than 2 weeks, etc.).
• The patient was not followed up according to the protocol.
• Other circumstances in which withdrawal from the study was deemed necessary by the investigator.

Sponsors & Collaborators

• Fudan University: lead
• Wuhan TongJi Hospital: collaborator
• Shanghai Chest Hospital: collaborator

Study Sites (3)

Wuhan Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200050, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib; aumolertinib; aflutinib

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 26, 2024
• Study Start: September 1, 2018
• Primary Completion: August 1, 2024
• Study Completion: February 20, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-02

Locations

CN (3)