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Efficacy and Safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC (FUTURE)

Sponsor
Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05255406
Collaborator
Allist Pharmaceuticals, Inc. (Industry)
62
Enrollment
1
Location
1
Arm
36.7
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC.

Condition or Disease Intervention/Treatment Phase
  • Drug: Furmonertinib (160mg)
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Single-arm, Phase 2 Clinical Trial of Furmonertinib as the First-line Treatment in EGFR-Mutant, PD-L1+ Patients With Locally Advanced or Metastatic NSCLC
Actual Study Start Date :
Dec 9, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Furmonertinib

Furmonertinib (160mg)

Drug: Furmonertinib (160mg)
160mg/day orally on a continuous dosing schedule. If subjects suffer from AEs, they can get declined dosage (80mg).
Other Names:
  • AST2818

    		•

    Outcome Measures

    Primary Outcome Measures

    1. One-year Progression Free Survival Rate [One year after inclusion]

      Percentage of subjects still alive and progression free one year after inclusion in the study.

    Secondary Outcome Measures

    1. One-year Overall Survival Rate [one year after inclusion]

      Percentage of subjects still alive one year after inclusion in the study.

    2. Progression Free Survival [Approximately 2 years following the first dose of study drugs]

      The time from the first does of the study drugs to the progression of the disease or death for any reason.

    3. Objective Response Rate [Approximately 2 years following the first dose of study drugs]

      Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.

    4. Adverse Events [Until 28 days from the last dose of study drugs or initiation of a new anticancer treatment]

      Number of participants with adverse events as a measure of safety and tolerability.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female subjects aged ≥18 years old;

    2. Locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology (stage ⅢB-Ⅳ, according to the 8th Edition of the AJCC Staging system);

    3. The tumour harbours one of the most common EGFR mutations (19del or L858R);

    4. The programmed death-ligand 1 (PD-L1) tumoral expression is positive;

    5. No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;

    6. According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline;

    7. ECOG performance status score 0-2；

    8. Subjects have voluntarily participated, signed and dated informed consent.

    Exclusion Criteria:

    1. Lung squamous carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma) and small cell lung cancer;

    2. Subjects have no measurable tumor lesion at baseline;

    3. Subjects with spinal cord compression or symptomatic brain metastases;

    4. Subjects are suitable for surgery;

    5. Previous therapy with platinum-based chemotherapy, EGFR-TKIs, or anti-PD1/PD-L1 agents;

    6. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 × ULN, or serum total bilirubin (TBIL)>1.5 × ULN, or Cr>1.0×ULN;

    7. Absolute value of neutrophil (ANC)<1.5 × 109/L, or platelet (PLT) count<75 × 109/L, or hemoglobin (HGB)<90 g/L;

    8. Any of the following disease within 12 months: myocardial infarction, severe/unstable stenocardia, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident;

    9. Women who are pregnancy or lactation, or fertile but not using contraception;

    10. Suffering from other serious acute or chronic physical or mental problems;

    11. Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Shanghai Cancer Center Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University
    • Allist Pharmaceuticals, Inc.

    Investigators

    • Principal Investigator: Hui Yu, MD, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Huiyu, associate senior doctor, Fudan University
    ClinicalTrials.gov Identifier:
    NCT05255406
    Other Study ID Numbers:
    • FMTN-IIT-2021-001
    First Posted:
    Feb 24, 2022
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Aflutinib

    Study Results

    No Results Posted as of Aug 4, 2022