Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC

Sponsor
The First Affiliated Hospital of Henan University of Science and Technology (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05209256
Collaborator
(none)
90
2
34.1

Study Details

Study Description

Brief Summary

Aim: the aim of this study is to investigated whether the combination of alflutinib with cytotoxic chemotherapy might hold additive efficacy, as well as tolerability .

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

alflutinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that is active in the central nervous system (CNS) and which potently and selectively inhibits mutant forms of EGFR with both TKI-sensitising (activating) mutations and the T790M resistance-conferring mutation. However, resistance to alflutinib inevitably emerges. One promising strategy to further improve patient prognosis and to approach a cure is combination therapy with alflutinib and other agents such as cytotoxic chemotherapeutic drugs.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Alflutinib Versus Alflutinib Plus Chemotherapy for Nonesmall Cell Lung Cancer With EGFR (T790M)- Associated Resistance to Initial EGFR Inhibitor Treatment: An Open-label, Randomised Phase 2 Clinical Trial
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alflutinib plus chemotherapy

Those in the combination group received concurrent alflutinib (80 mg daily), as well as carboplatin (area under the curve [AUC] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.

Drug: Alflutinib plus chemotherapy
Those in the combination group received concurrent alflutinib (80 mg daily), as well as carboplatin (area under the curve [AUC] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.
Other Names:
  • AST2818
  • Pulaile
  • Sham Comparator: chemotherapy

    arboplatin (area under the curve [AUC] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.

    Drug: Chemotherapy
    Patients in the alflutinib group received alflutinib (80 mg daily) until disease progression, unacceptable toxicity, or death.
    Other Names:
  • pemetrexed
  • Pulaile
  • Outcome Measures

    Primary Outcome Measures

    1. PFS [16 weeks]

      Disease-free survival

    Secondary Outcome Measures

    1. Objective remission rate (ORR) [16 weeks]

      Objective remission rate

    2. Disease Control Rate ( DCR) [16 weeks]

      Disease Control Rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • histologically or cytologically diagnosed non-squamous NSCLC of stage IIIB or IV (based on the 7th edition of the TNM classification) or recurrent;

    • an EGFR mutation, including an exon-19 deletion (Ex19del), L858R, or other (L861Q, G719A, G719C, or G719S), as well as the T790M mutation of EGFR as detected in a tissue or liquid biopsy sample obtained after disease progression during first-line EGFR-TKI (gefitinib, erlotinib, or afatinib) treatment;

    • WHO performance status of 0 or 1;

    • no prior neoadjuvant or adjuvant chemotherapy in the 12 months preceding study enrollment;

    • adequate bone marrow reserve and organ function.

    Exclusion Criteria:
    • treatment with an EGFR-TKI within 7 days of the first dose of the study treatment;

    • symptomatic CNS metastases;

    • evidence of interstitial pneumonia, pulmonary fibrosis, or radiation pneumonitis requiring steroid treatment as revealed by a computed tomography (CT) scan.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The First Affiliated Hospital of Henan University of Science and Technology

    Investigators

    • Principal Investigator: Xinshuai Wang, PHD, The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology
    • Principal Investigator: Guoqiang Kong, MD, The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology
    • Principal Investigator: Xiaozhi Yuan, MD, The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology
    • Principal Investigator: Jing Ren, MD, The First Affiliated Hospital of Clinical Medicine of Henan University of Science and Technology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The First Affiliated Hospital of Henan University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT05209256
    Other Study ID Numbers:
    • ALF-IN-NSCLC-001
    First Posted:
    Jan 26, 2022
    Last Update Posted:
    Jan 26, 2022
    Last Verified:
    Oct 1, 2021
    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
    Keywords provided by The First Affiliated Hospital of Henan University of Science and Technology
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2022