Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC

January 25, 2022 updated by: The First Affiliated Hospital of Henan University of Science and Technology

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

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 16 weeks
Disease-free survival
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate (ORR)
Time Frame: 16 weeks
Objective remission rate
16 weeks
Disease Control Rate ( DCR)
Time Frame: 16 weeks
Disease Control Rate
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALF-IN-NSCLC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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