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Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)

Primary Purpose

Lung Adenocarcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Furmonertinib
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study.
  • Primary lung adenocarcinoma diagnosed histologically/cytologically.
  • Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators.
  • EGFR mutation positive (19Del or L858R, with or without T790M)
  • The presence of at least one measurable lesion and suitable for accurate repeated measurements.
  • ECOG performance status 0-1.
  • For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.

Exclusion Criteria:

  • Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma.
  • Patients with EGFR exon 20 insertion mutation.
  • Exposure to other antitumor therapies prior to enrolment.
  • Major surgery was performed in the four weeks prior to the first dosing of the study drug.
  • Pregnant or lactating female patients.
  • Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration.
  • Have a history of or present complications with other malignancies.
  • Patients with severe or uncontrolled systemic disease requiring treatment were not considered suitable for the study.
  • ECG QT interval prolongation or associated risk.
  • A history of interstitial pneumonia or related risk.
  • Inadequate bone marrow or organ reserve.
  • Other circumstances that are not suitable for participation in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Furmonertinib

    Arm Description

    Furmonertinib as perioperation therapy

    Outcomes

    Primary Outcome Measures

    Objective Response Rate (ORR)
    Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1

    Secondary Outcome Measures

    Disease Control Rate (DCR)
    Proportion of patients whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1
    Progression free survival (PFS)
    The time from the first does of the study drugs to the progression of the disease or death for any reason.
    Disease free survival (DFS)
    The time from the end of surgery to the progression of the disease or death for any reason.
    Adverse Events (AEs)
    The number of patients with adverse events and the severity according to CTCAE v5.0

    Full Information

    First Posted
    June 27, 2021
    Last Updated
    July 8, 2021
    Sponsor
    Tianjin Medical University Cancer Institute and Hospital
    Collaborators
    Allist Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04965831
    Brief Title
    Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)
    Official Title
    Furmonertinib Mesylate as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable, EGFR Sensitizing Mutation Positive Lung Adenocarcinoma Patients: A Phase II, Single-arm, Open-label Clinical Study (FRONT)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2021 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    May 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tianjin Medical University Cancer Institute and Hospital
    Collaborators
    Allist Pharmaceuticals, Inc.

    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
    This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.
    Detailed Description
    Please refer to detailed description in the following context.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Adenocarcinoma

    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
    Arm Type
    Experimental
    Arm Description
    Furmonertinib as perioperation therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Furmonertinib
    Other Intervention Name(s)
    AST2818
    Intervention Description
    Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery.
    Primary Outcome Measure Information:
    Title
    Objective Response Rate (ORR)
    Description
    Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1
    Time Frame
    Approximately 8 weeks following the first dose of study drug
    Secondary Outcome Measure Information:
    Title
    Disease Control Rate (DCR)
    Description
    Proportion of patients whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1
    Time Frame
    Approximately 8 weeks following the first dose of study drug
    Title
    Progression free survival (PFS)
    Description
    The time from the first does of the study drugs to the progression of the disease or death for any reason.
    Time Frame
    Approximately 3 years following the first dose of study drug
    Title
    Disease free survival (DFS)
    Description
    The time from the end of surgery to the progression of the disease or death for any reason.
    Time Frame
    Approximately 3 years following the first dose of study drug
    Title
    Adverse Events (AEs)
    Description
    The number of patients with adverse events and the severity according to CTCAE v5.0
    Time Frame
    From the start of study drug to 28 days after the last dose of study drug
    Other Pre-specified Outcome Measures:
    Title
    Circulating tumor DNA clearance rate
    Description
    The proportion of patients with circulating tumor DNA clearance after neoadjuvant therapy
    Time Frame
    Approximately 8 weeks following the first dose of study drug
    Title
    Minimal residual disease rate
    Description
    The proportion of patients with minimal residual disease defined as detectable ctDNA with a variant allele fraction of at least 0.1% in plasma after surgery
    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: The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study. Primary lung adenocarcinoma diagnosed histologically/cytologically. Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators. EGFR mutation positive (19Del or L858R, with or without T790M) The presence of at least one measurable lesion and suitable for accurate repeated measurements. ECOG performance status 0-1. For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose. Exclusion Criteria: Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma. Patients with EGFR exon 20 insertion mutation. Exposure to other antitumor therapies prior to enrolment. Major surgery was performed in the four weeks prior to the first dosing of the study drug. Pregnant or lactating female patients. Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration. Have a history of or present complications with other malignancies. Patients with severe or uncontrolled systemic disease requiring treatment were not considered suitable for the study. ECG QT interval prolongation or associated risk. A history of interstitial pneumonia or related risk. Inadequate bone marrow or organ reserve. Other circumstances that are not suitable for participation in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Changli Wang, MD
    Phone
    +86 022-23340123
    Email
    aswindcc@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Changli Wang, MD
    Organizational Affiliation
    Tianjin Medical University Cancer Institute and Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The IPD sharing plan is not to be shared according to the policy.

    Learn more about this trial

    Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)

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