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A Study of Furmonertinib Combined With Radiotherapy for Non-small Cell Lung Cancer With Oligoprogression

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04970693
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase II randomized study is to explore the efficacy and safety of Furmonertinib combined with radiotherapy for non-small cell lung cancer with oligoprogression after first-line EGFR-TKI therapy.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This Phase II randomized study is to explore the efficacy and safety of Furmonertinib combined with radiotherapy for non-small cell lung cancer with oligoprogression after first-line EGFR-TKI therapy.

The first group will enroll NSCLC patients with oligoprogression after using the first/second generation EGFR-TKI. The participants will receive Furmonertinib 80mg and local radiotherapy as the following therapy.

The other group will enroll NSCLC patients with oligoprogression after using the third generation EGFR-TKI. The participants will receive Furmonertinib 160mg and local radiotherapy as the following therapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Single-arm Study of Furmonertinib Combined With Radiotherapy for Non-small Cell Lung Cancer With Oligoprogression After First-line EGFR-TKI Therapy
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Furmonertinib 80mg combined with radiotherapy

This group will enroll NSCLC patients who are oligoprogressive after first/second generation EGFR-TKI therapy. These patients will receive furmonertinib 80mg combined with radiotherapy as following therapy.

Drug: Furmonertinib
The different dose of furmonertinib will be given according to the generation of EGFR-TKI used as the first-line therapy. The doses and target volume of radiotherapy will be decided according to the oligoprogressive sites.
Other Names:
  • Radiotherapy

    		•
    Experimental: Furmonertinib 160mg combined with radiotherapy

    This group will enroll NSCLC patients who are oligoprogressive after third generation EGFR-TKI therapy. These patients will receive furmonertinib 160mg combined with radiotherapy as following therapy.

    Drug: Furmonertinib
    The different dose of furmonertinib will be given according to the generation of EGFR-TKI used as the first-line therapy. The doses and target volume of radiotherapy will be decided according to the oligoprogressive sites.
    Other Names:
  • Radiotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression-free survival [2-year]

      From the first day of treatment to the day of progression or the day of death.

    Secondary Outcome Measures

    1. Overall survival [2-year]

      It was calculated from the first day of treatment to the day of death.

    2. Failure pattern [2-year]

      Disease progression such as local recurrence or distant metastasis.

    3. Safety evaluation [2 year after therapy]

      Adverse effects are graded according to the CTCAE 5.0 version, including multiple organs and tissues, such as gastrointestinal disease and symptom, cardiovascular disease, respiratory diseases and so on.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with locally advanced or metastatic NSCLC who are diagnosed by histology or cytology and are not suitable for surgery or radiotherapy;

    • After receiving the first or second generation of EGFR-TKI treatment, the disease is oligoprogressive with 3-5 lesions (with imaging evidence), and the mutation is T790M+ (histological or hematological specimens, ARMS detection method);

    • After receiving osimertinib treatment in the past, the disease is oligoprogressive with 3-5 lesions (with imaging evidence), and the patient refused chemotherapy;

    • 18-80 years old;

    • ECOG PS 0-2 scores;

    • Organ and bone marrow functions were generally normal within 30 days before enrollment, including:AST, ALT ≤ 2.5 × ULN or ≤ 5 × ULN (with liver metastasis); total bilirubin ≤ 1.5 × ULN; neutrophils absolute value ≥ 1500 cells/mm3; Creatinine clearance ≥45 mL/min; Platelets ≥ 100,000 cells/mm3; Hemoglobin ≥90g/L.

    • The baseline has measurable lesions defined by the RECIST 1.1 standard, and the progressive lesions should be treated with local radiotherapy; the definition of the lesion number includes:

    1. When there are lesions on both adrenal glands, it is considered to be 2 metastases;

    2. Two consecutive vertebral lesions and a paravertebral lesion within 6 cm can be considered as one metastasis, and the non-contiguous vertebral lesions should be counted separately;

    3. The adjacent lesions in the liver, lung, and mediastinum can be considered as a metastasis if one isocenter can be used for irradiation;

    4. Intracranial lesions are counted as 1 metastasis.

    • The patient signed an informed consent form.
    Exclusion Criteria:

    • Severe or uncontrolled hypertension, diabetes, coronary artery stenosis, aortic dissection, aneurysm or acute bleeding disease;

    • Any situation that increases the risk of QTc prolongation or arrhythmia;

    • Left ventricular ejection fraction <50%;

    • History of interstitial lung disease;

    • FEV1%<30% or DLCO%<40%;

    • Insertion of EGFR exon 20;

    • The researcher believes that the patient is inappropriate to participate in this trial.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun yat-sen University Cancer Center Guangzhou Guangdong China 510000

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    • Principal Investigator: Hui Liu, Sun yat-sen universtiy cancer center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hui Liu, Professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT04970693
    Other Study ID Numbers:
    • GASTO-1079
    First Posted:
    Jul 21, 2021
    Last Update Posted:
    Jul 21, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hui Liu, Professor, Sun Yat-sen University
    non-small cell lung cancer
    oligoprogressive
    Furmonertinib combined with radiotherapy
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jul 21, 2021