AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases

NCT06604689 | Recruiting

• 1 other identifier: BM-AI
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopathological parameters, which are used to construct a multimode model that can accurately predict the treatment efficacy and survival of the third-generation EGFR-TKI treatment, and to use the model to assist in screening high-risk populations suitable for upfront cranial radiotherapy. Participants receiving third-generation EGFR-TKI treatment will be enrolled in our study and we will collect their regular contrast-enhanced chest CT and contrast-enhanced brain MRI for model construction.

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer); Brain Metastasases

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  The time from the start of EGFR-TKI treatment until the documentation of disease progression or death from any cause, assessed according to the RECIST 1.1 criteria. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date.

  1 year

Secondary Outcomes (4)

• Intracranial Objective Response Rate (iORR)

  1 year

• Intracranial Progression-Free Survival (iPFS)

  1 year

• Overall Survival (OS)

  1 year

• Objective Response Rate (ORR)

  1 year

Study Arms (2)

Construction of AI models (retrospective cohort)

Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)

Validation of AI models (prospective cohort)

Drug: third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib)

Interventions

third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) DRUG

EGFR-mutated NSCLC patients with brain metastases who met the inclusion and exclusion criteria, would receive first-line third-generation EGFR-TKI treatment (monotherapy or combined with upfront cranial radiotherapy)

Construction of AI models (retrospective cohort); Validation of AI models (prospective cohort)

Eligibility Criteria

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

Study Population

Patients are collected all over china, diagnosed with EGFR-mutant NSCLC with brain metastases.

You may qualify if:

• Pathologically confirmed non-small cell lung cancer;
• clinical stage IV (AJCC, 8th edition, 2017);
• EGFR sensitive mutations: EGFR L858R, EGFR exon 19 deletion;
• age≥18 years old;
• KPS score≥70;
• brain metastases at diagnosis;
• 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;
• EGFR sensitive mutations were negative or EGFR mutation status was not detected.
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Shanghai Cancer center

Shanghai, Shanghai Municipality, 200050, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

zhengfei Zhu

CONTACT

+86-18017312901; fuscczzf@163.com

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 18, 2024
• First Posted: September 19, 2024
• Study Start: September 30, 2024
• Primary Completion: April 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CN (1)