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

NCT05987826 | Unknown Phase 2

• 1 other identifier: B2023-170R
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

furmonertinib; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• objective response rate(ORR)

  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 Outcomes (7)

• Main Pathological Response（MPR）

  Approximately 12 weeks following the first dose of study drug

• Pathological Complete Response Rate（pCR)

  Approximately 12 weeks following the first dose of study drug

• Pathological Nodal Downstaging Rate

  Approximately 12 weeks following the first dose of study drug

• Delayed Surgery Rate

  Approximately 12 weeks following the first dose of study drug

• Rate of R0 Resection

  Approximately 12 weeks following the first dose of study drug

Study Arms (1)

Furmonertinib (AST2818) 80mg QD group

EXPERIMENTAL

All patients enrolled into this study will receive furmonertinib 80mg for 8 weeks neoadjuvant therapy before surgery.

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

Furmonertinib 80mg QD oral 8 weeks.

Also known as: Furmonertinib(AST2818)

Furmonertinib (AST2818) 80mg QD group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）Provide informed consent prior to any study specific procedures
• ）at least 18 years of age，not more than 75 years
• ）Histology or cytology diagnose of non-small cell lung cancer within 60 days
• ）ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
• ）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
• ）According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm)
• ）EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
• ）Without prior anti-tumor treatment
• \) Withe adequate organ function of hematology, liver and kidney
• ）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

You may not qualify if:

• ）Dual or multiple primary NSCLC
• ）Any prior anti-tumor treatment
• ）With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
• ）History of interstitial lung disease or with relative risk factors
• ）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
• ）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
• ）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
• ）Prolongation of ECG QTc or with relative risk factors
• ）psychopath and/or mental illness
• ）Pre-existing or coexisting bleeding disorders
• ）Women with pregnancy or breastfeeding
• ）Allergic to study drugs or any component
• ）Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Xuhui Central Hospital, Shanghai: collaborator
• Shanghai Minhang Central Hospital: collaborator
• Shanghai Zhongshan Hospital Qingpu Branch: collaborator
• Ningbo No. 1 Hospital: collaborator

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Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

di ge

CONTACT

86-18202188606; gedi@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2025
• Last Updated: August 14, 2023

Record last verified: 2023-08