Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC

August 10, 2023 updated by: Shanghai Zhongshan Hospital

Furmonertinib Mesylate Neoadjuvant Treatment of Resectable Stage Ⅱ-ⅢB Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor（EGFR）Sensitive Mutation：a Prospective，Muliticenter，Open Label，Phase Ⅱ Single-arm Study

EGFR-TKI has firmly established itself as a first-line treatment for advanced lung cancer with EGFR-sensitive mutations, and the ADAURA study has added to its indications for use as postoperative adjuvant therapy in early- and mid-stage lung cancer.However, clinical data on neoadjuvant EGFR-TKI therapy are still incomplete. A phase II clinical study, CTONG1103, currently ongoing, comparing the efficacy of the first generational EGFR-TKI erlotinib and gemcitabine combined with cisplatin as neoadjuvant therapy for stage IIIA-N2 EGFR mutation-positive non-small-cell lung cancer, did not yield significantly positive objective remission rate (ORR) results.

Furmonertinib is a third-generation Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations.Furmonertinib demonstrates definite efficacy and favorable safety in first-line EGFR-sensitive mutations and EGFR T790M Mutations in second-line and late-line treatment of advanced NSCLC.The aim of this study was to explore the efficacy and safety of furmonertinib neoadjuvant therapy for resectable stage II-IIIB EGFR-sensitive mutant non-small cell lung cancer efficacy and safety. Patinents are planned to be recruited from five centers in China. Eligible patients will receive furmonertinib neoadjuvant therapy for 8 weeks to evaluate the efficacy and safety of furmonnertinib neoadjuvant.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Not Provided

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1）Provide informed consent prior to any study specific procedures
  • 2）at least 18 years of age，not more than 75 years
  • 3）Histology or cytology diagnose of non-small cell lung cancer within 60 days
  • 4）ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
  • 5）Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging), with stage IIIB only including cT3N2M0 patients
  • 6）According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm)
  • 7）EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
  • 8）Without prior anti-tumor treatment
  • 9) Withe adequate organ function of hematology, liver and kidney
  • 10）Using adequate and effective contraception, Male patients should be use condoms; women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age

Exclusion Criteria:

  • 1）Dual or multiple primary NSCLC
  • 2）Any prior anti-tumor treatment
  • 3）With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
  • 4）History of interstitial lung disease or with relative risk factors
  • 5）Diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting
  • 6）Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrolment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrolment
  • 7）With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
  • 8）Prolongation of ECG QTc or with relative risk factors
  • 9）psychopath and/or mental illness
  • 10）Pre-existing or coexisting bleeding disorders
  • 11）Women with pregnancy or breastfeeding
  • 12）Allergic to study drugs or any component
  • 13）Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Furmonertinib (AST2818) 80mg QD group
All patients enrolled into this study will receive furmonertinib 80mg for 8 weeks neoadjuvant therapy before surgery.
Drug: Furmonertinib
Furmonertinib 80mg QD oral 8 weeks.
Other Names:
  • Furmonertinib(AST2818)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate(ORR)
Time Frame: Approximately 8 weeks following the first dose of study drug
According to RECIST 1.1 criteria, after 8 weeks of neoadjuvant therapy with furmonertinib CT scans scans assessed the proportion of patients in partial and complete remission.
Approximately 8 weeks following the first dose of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Main Pathological Response（MPR）
Time Frame: Approximately 12 weeks following the first dose of study drug
Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology
Approximately 12 weeks following the first dose of study drug
Pathological Complete Response Rate（pCR)
Time Frame: Approximately 12 weeks following the first dose of study drug
The proportion of patients with pathological response rate in the resected tumor.
Approximately 12 weeks following the first dose of study drug
Pathological Nodal Downstaging Rate
Time Frame: Approximately 12 weeks following the first dose of study drug
Neoadjuvant confirmed by pathologic evaluation of tumors and other tissues removed during surgery Percentage of patients downregulated from lymph node-positive to negative after treatment
Approximately 12 weeks following the first dose of study drug
Delayed Surgery Rate
Time Frame: Approximately 12 weeks following the first dose of study drug
Proportion of surgeries performed 2 weeks after the last dose of furmonertinib because of adverse drug reactions and other reasons.
Approximately 12 weeks following the first dose of study drug
Rate of R0 Resection
Time Frame: Approximately 12 weeks following the first dose of study drug
The proportion of patients with R0 resection.
Approximately 12 weeks following the first dose of study drug
Percentage of minimally invasive mid-rotation open chest
Time Frame: Approximately 12 weeks following the first dose of study drug
Proportion of minimally invasive surgeries converted to open thoracic for various reasons
Approximately 12 weeks following the first dose of study drug
Incidence of adverse drug events (AE)
Time Frame: Approximately 12 weeks following the first dose of study drug
Unfavorable clinical events in the course of drug treatment
Approximately 12 weeks following the first dose of study drug

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

Collaborators

Ningbo No. 1 Hospital
Shanghai Minhang Central Hospital
Xuhui Central Hospital, Shanghai
Shanghai Zhongshan Hospital Qingpu Branch

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

Helpful Links

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 (Estimated)

August 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 10, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2023-170R

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.

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on Furmonertinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe