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Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC

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ClinicalTrials.gov Identifier: NCT05209256
Recruitment Status : Not yet recruiting
First Posted : January 26, 2022
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Henan University of Science and Technology

Study Description
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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
NSCLC Drug: Chemotherapy Drug: Alflutinib plus chemotherapy 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Pemetrexed

Arms and Interventions
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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
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Primary Outcome Measures :
  1. PFS [ Time Frame: 16 weeks ]
    Disease-free survival


Secondary Outcome Measures :
  1. Objective remission rate (ORR) [ Time Frame: 16 weeks ]
    Objective remission rate

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05209256


Contacts
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Contact: Jiachun Sun, PHD 18638882757 sunjiachun1980@126.com
Contact: Tanyou Shan, MD 18537976669 shantanyoudoctor@163.com

Sponsors and Collaborators
The First Affiliated Hospital of Henan University of Science and Technology
Investigators
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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
More Information
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Publications:

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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: January 26, 2022    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
NSCLC ，EGFR(T790M)，alflutinib
Additional relevant MeSH terms:
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Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors