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NCT Number: NCT06604689

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Cancer center

Shanghai, Shanghai Municipality, 200050, China

Location status: Recruiting

Location contact

Zhengfei Zhu, PhD

CONTACT

[email protected]

86+137 6408 8764

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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)

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 1 year

    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.

Secondary outcomes

  1. Intracranial Objective Response Rate (iORR)

    Time frame: 1 year

    The percentage of participants in the analysis population whose brain lesions achieve CR or PR, assessed according to the modified RECIST 1.1 criteria.

  2. Intracranial Progression-Free Survival (iPFS)

    Time frame: 1 year

    The time from the start of EGFR-TKI treatment until the documentation of intracranial disease progression or death from any cause. If the patients have extracranial disease progression (without intracranial disease progression), the cutoff date was the date of the first occurrence of extracranial disease progression. Patients who have not progressed at the time of analysis will have their last contact date used as the cutoff date.

  3. Overall Survival (OS)

    Time frame: 1 year

    The time from the start of EGFR-TKI treatment until death from any cause. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date.

  4. Objective Response Rate (ORR)

    Time frame: 1 year

    The percentage of participants who achieve a Complete Response (CR) or Partial Response (PR) after treatment, assessed according to the RECIST 1.1 criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

zhengfei Zhu

CONTACT

[email protected]

+86-18017312901

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Artificial Intelligence-guided Prognostication and Cranial Radiotherapy Optimization in First-line Third-generation EGFR-TKI-treated EGFR-mutant Non-small Cell Lung Cancer With Baseline Brain Metastases: a Multicenter, Observational Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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