Clinical trial NCT05987826: Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: furmonertinib
neoadjuvant therapy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
Collaborators: name: Xuhui Central Hospital, Shanghai
name: Shanghai Minhang Central Hospital
name: Shanghai Zhongshan Hospital Qingpu Branch
name: Ningbo No. 1 Hospital
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Not Provided

Eligibility criteria: 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

Primary outcomes:
measure: objective response rate(ORR)
timeFrame: Approximately 8 weeks following the first dose of study drug
Secondary outcomes:
measure: Main Pathological Response（MPR）
timeFrame: Approximately 12 weeks following the first dose of study drug
measure: Pathological Complete Response Rate（pCR)
timeFrame: Approximately 12 weeks following the first dose of study drug
measure: Pathological Nodal Downstaging Rate
timeFrame: Approximately 12 weeks following the first dose of study drug
measure: Delayed Surgery Rate
timeFrame: Approximately 12 weeks following the first dose of study drug
measure: Rate of R0 Resection
timeFrame: Approximately 12 weeks following the first dose of study drug
measure: Percentage of minimally invasive mid-rotation open chest
timeFrame: Approximately 12 weeks following the first dose of study drug
measure: Incidence of adverse drug events (AE)
timeFrame: Approximately 12 weeks following the first dose of study drug
Other outcomes:
Locations:
Study officials:
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