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Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC

Primary Purpose

Non-Small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Furmonertinib
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring furmonertinib, neoadjuvant therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1)Provide informed consent prior to any study specific procedures 2)at least 18 years of age,not more than 75 years 3)Histology or cytology diagnose of non-small cell lung cancer within 60 days 4)ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks 5)Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging), with stage IIIB only including cT3N2M0 patients 6)According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm) 7)EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations) 8)Without prior anti-tumor treatment 9) Withe adequate organ function of hematology, liver and kidney 10)Using adequate and effective contraception, Male patients should be use condoms; women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age Exclusion Criteria: 1)Dual or multiple primary NSCLC 2)Any prior anti-tumor treatment 3)With history of other malignancy except for radical resected tumors without recurrence for 5 years or more 4)History of interstitial lung disease or with relative risk factors 5)Diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting 6)Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrolment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrolment 7)With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment 8)Prolongation of ECG QTc or with relative risk factors 9)psychopath and/or mental illness 10)Pre-existing or coexisting bleeding disorders 11)Women with pregnancy or breastfeeding 12)Allergic to study drugs or any component 13)Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Furmonertinib (AST2818) 80mg QD group

    Arm Description

    All patients enrolled into this study will receive furmonertinib 80mg for 8 weeks neoadjuvant therapy before surgery.

    Outcomes

    Primary Outcome Measures

    objective response rate(ORR)
    According to RECIST 1.1 criteria, after 8 weeks of neoadjuvant therapy with furmonertinib CT scans scans assessed the proportion of patients in partial and complete remission.

    Secondary Outcome Measures

    Main Pathological Response(MPR)
    Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology
    Pathological Complete Response Rate(pCR)
    The proportion of patients with pathological response rate in the resected tumor.
    Pathological Nodal Downstaging Rate
    Neoadjuvant confirmed by pathologic evaluation of tumors and other tissues removed during surgery Percentage of patients downregulated from lymph node-positive to negative after treatment
    Delayed Surgery Rate
    Proportion of surgeries performed 2 weeks after the last dose of furmonertinib because of adverse drug reactions and other reasons.
    Rate of R0 Resection
    The proportion of patients with R0 resection.
    Percentage of minimally invasive mid-rotation open chest
    Proportion of minimally invasive surgeries converted to open thoracic for various reasons
    Incidence of adverse drug events (AE)
    Unfavorable clinical events in the course of drug treatment

    Full Information

    First Posted
    August 3, 2023
    Last Updated
    August 10, 2023
    Sponsor
    Shanghai Zhongshan Hospital
    Collaborators
    Xuhui Central Hospital, Shanghai, Shanghai Minhang Central Hospital, Shanghai Zhongshan Hospital Qingpu Branch, Ningbo No. 1 Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05987826
    Brief Title
    Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC
    Official Title
    Furmonertinib Mesylate Neoadjuvant Treatment of Resectable Stage Ⅱ-ⅢB Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor(EGFR)Sensitive Mutation:a Prospective,Muliticenter,Open Label,Phase Ⅱ Single-arm Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    August 2024 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Zhongshan Hospital
    Collaborators
    Xuhui Central Hospital, Shanghai, Shanghai Minhang Central Hospital, Shanghai Zhongshan Hospital Qingpu Branch, Ningbo No. 1 Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    EGFR-TKI has firmly established itself as a first-line treatment for advanced lung cancer with EGFR-sensitive mutations, and the ADAURA study has added to its indications for use as postoperative adjuvant therapy in early- and mid-stage lung cancer.However, clinical data on neoadjuvant EGFR-TKI therapy are still incomplete. A phase II clinical study, CTONG1103, currently ongoing, comparing the efficacy of the first generational EGFR-TKI erlotinib and gemcitabine combined with cisplatin as neoadjuvant therapy for stage IIIA-N2 EGFR mutation-positive non-small-cell lung cancer, did not yield significantly positive objective remission rate (ORR) results. Furmonertinib is a third-generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations.Furmonertinib demonstrates definite efficacy and favorable safety in first-line EGFR-sensitive mutations and EGFR T790M Mutations in second-line and late-line treatment of advanced NSCLC.The aim of this study was to explore the efficacy and safety of furmonertinib neoadjuvant therapy for resectable stage II-IIIB EGFR-sensitive mutant non-small cell lung cancer efficacy and safety. Patinents are planned to be recruited from five centers in China. Eligible patients will receive furmonertinib neoadjuvant therapy for 8 weeks to evaluate the efficacy and safety of furmonnertinib neoadjuvant.
    Detailed Description
    Not Provided

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small Cell Lung Cancer
    Keywords
    furmonertinib, neoadjuvant therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Furmonertinib (AST2818) 80mg QD group
    Arm Type
    Experimental
    Arm Description
    All patients enrolled into this study will receive furmonertinib 80mg for 8 weeks neoadjuvant therapy before surgery.
    Intervention Type
    Drug
    Intervention Name(s)
    Furmonertinib
    Other Intervention Name(s)
    Furmonertinib(AST2818)
    Intervention Description
    Furmonertinib 80mg QD oral 8 weeks.
    Primary Outcome Measure Information:
    Title
    objective response rate(ORR)
    Description
    According to RECIST 1.1 criteria, after 8 weeks of neoadjuvant therapy with furmonertinib CT scans scans assessed the proportion of patients in partial and complete remission.
    Time Frame
    Approximately 8 weeks following the first dose of study drug
    Secondary Outcome Measure Information:
    Title
    Main Pathological Response(MPR)
    Description
    Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology
    Time Frame
    Approximately 12 weeks following the first dose of study drug
    Title
    Pathological Complete Response Rate(pCR)
    Description
    The proportion of patients with pathological response rate in the resected tumor.
    Time Frame
    Approximately 12 weeks following the first dose of study drug
    Title
    Pathological Nodal Downstaging Rate
    Description
    Neoadjuvant confirmed by pathologic evaluation of tumors and other tissues removed during surgery Percentage of patients downregulated from lymph node-positive to negative after treatment
    Time Frame
    Approximately 12 weeks following the first dose of study drug
    Title
    Delayed Surgery Rate
    Description
    Proportion of surgeries performed 2 weeks after the last dose of furmonertinib because of adverse drug reactions and other reasons.
    Time Frame
    Approximately 12 weeks following the first dose of study drug
    Title
    Rate of R0 Resection
    Description
    The proportion of patients with R0 resection.
    Time Frame
    Approximately 12 weeks following the first dose of study drug
    Title
    Percentage of minimally invasive mid-rotation open chest
    Description
    Proportion of minimally invasive surgeries converted to open thoracic for various reasons
    Time Frame
    Approximately 12 weeks following the first dose of study drug
    Title
    Incidence of adverse drug events (AE)
    Description
    Unfavorable clinical events in the course of drug treatment
    Time Frame
    Approximately 12 weeks following the first dose of study drug

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1)Provide informed consent prior to any study specific procedures 2)at least 18 years of age,not more than 75 years 3)Histology or cytology diagnose of non-small cell lung cancer within 60 days 4)ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks 5)Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging), with stage IIIB only including cT3N2M0 patients 6)According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm) 7)EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations) 8)Without prior anti-tumor treatment 9) Withe adequate organ function of hematology, liver and kidney 10)Using adequate and effective contraception, Male patients should be use condoms; women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age Exclusion Criteria: 1)Dual or multiple primary NSCLC 2)Any prior anti-tumor treatment 3)With history of other malignancy except for radical resected tumors without recurrence for 5 years or more 4)History of interstitial lung disease or with relative risk factors 5)Diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting 6)Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrolment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrolment 7)With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment 8)Prolongation of ECG QTc or with relative risk factors 9)psychopath and/or mental illness 10)Pre-existing or coexisting bleeding disorders 11)Women with pregnancy or breastfeeding 12)Allergic to study drugs or any component 13)Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    di ge
    Phone
    86-18202188606
    Email
    gedi@zs-hospital.sh.cn

    12. IPD Sharing Statement

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    Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC

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