Status:
UNKNOWN
Study of Furmonertinib as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutant NSCLC
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
Xuhui Central Hospital, Shanghai
Shanghai Minhang Central Hospital
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 adju...
Detailed Description
Not Provided
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05987826
Start Date
August 1 2023
End Date
December 1 2025
Last Update
August 14 2023
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