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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05987826
• Other study ID #: B2023-170R
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 2023
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: Shanghai Zhongshan Hospital
• Contact: di ge
• Phone: 86-18202188606
• Email: gedi[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Not Provided

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Furmonertinib
Furmonertinib 80mg QD oral 8 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (5)

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

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* Note: There are 44 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Main Pathological Response(MPR)	Proportion of resected specimens with =10% residual tumor cells assessed by surgical specimen pathology	Approximately 12 weeks following the first dose of study drug
Secondary	Pathological Complete Response Rate(pCR)	The proportion of patients with pathological response rate in the resected tumor.	Approximately 12 weeks following the first dose of study drug
Secondary	Pathological Nodal Downstaging Rate	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
Secondary	Delayed Surgery Rate	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
Secondary	Rate of R0 Resection	The proportion of patients with R0 resection.	Approximately 12 weeks following the first dose of study drug
Secondary	Percentage of minimally invasive mid-rotation open chest	Proportion of minimally invasive surgeries converted to open thoracic for various reasons	Approximately 12 weeks following the first dose of study drug
Secondary	Incidence of adverse drug events (AE)	Unfavorable clinical events in the course of drug treatment	Approximately 12 weeks following the first dose of study drug

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