Back to resultsNeoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIIA-IIIB Resectable NSCLC (FORESEE)
Primary Purpose
Non-small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Furmonertinib+cisplating/pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring furmonertinib, AST2818
Eligibility Criteria
Inclusion Criteria:
- With written informed consent before any study procedure
- Histology or cytology diagnose of non-small cell lung cancer within 60 days
- Stage IIIA/IIIB, with resectable lesion(s) by radiology
- EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
- Without prior anti-tumor treatment
- With at least one measurable lesions (The longest axis ≥10mm)
- ECOG performance status 0-1
- Using adequate and effective contraception, 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:
- EGFR Exon 20 insertions positive
- Mixed with small cell cancer, or other mixed types of lung cancer
- Any prior anti-tumor treatment
- Major surgery within 4 weeks before enrolment
- Women with pregnancy or breastfeeding
- 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 history of other malignancy except for radical resected tumors without recurrence for 5 years or more
- 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
- Severe gastrointestinal diseases which may affect the intake and absorption of study drug
- Prolongation of ECG QTc or with relative risk factors
- History of interstitial lung disease or with relative risk factors
- Inadequate organ function of hematology, liver and kidney
- Allergic to study drugs or any component
- Poor adherence or other situation judged by investigator
- Patients who had participated other clinical studies of tumors
Sites / Locations
- Tangdu HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Furmonertinib plus cisplatin/pemetrexed
Arm Description
furmonertinib 80mg/d for 9 weeks and cisplatin 75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv at 21 day cycles for 3 cycles
Outcomes
Primary Outcome Measures
Objective response rate
The proportion of patients with complete response or partial response
Secondary Outcome Measures
Major pathological response rate
The proportion of patients with pathological response in the resected tumor
Pathological complete response rate
The proportion of patients with pathological response rate in the resected tumor
R0 resection rate
The proportion of patients with R0 resection
Disease free survival
The time from enrolment to disease recurrence or death, which ever comes first
Overall survival
The time from enrolment to death of any reason
Pathological downstaging of lymph node rate
The proportion of patients with pathological downstaging of lymph node rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05430802
Brief Title
Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIIA-IIIB Resectable NSCLC (FORESEE)
Official Title
Furmonertinib Combined With Cisplatin/Pemetrexed as Neoadjuvant Therapy in EGFR Mutated Stage IIIA-IIIB Resectable Non-small Cell Lung Cancer (FORESEE): a Prospective, Open-label, Single-arm, Phase 2 Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this open-label, single-arm, phase 2 study, 40 eligible patients with EGFR mutated stage IIIA-IIIB resectable NSCLC will be recruited to receive furmonertinib for 9 weeks combined with cisplatin/pemetrexed for 3 cycles (21 d/cycle) as neoadjuvant therapy before radical surgery. Radiological and pathological evaluations will be performed before and after the neoadjuvant therapy to assess the efficacy of treatment. Adverse events during neoadjuvant therapy, disease and survival status will also be collected in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
furmonertinib, AST2818
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Furmonertinib plus cisplatin/pemetrexed
Arm Type
Experimental
Arm Description
furmonertinib 80mg/d for 9 weeks and cisplatin 75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv at 21 day cycles for 3 cycles
Intervention Type
Drug
Intervention Name(s)
Furmonertinib+cisplating/pemetrexed
Intervention Description
Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles
Primary Outcome Measure Information:
Title
Objective response rate
Description
The proportion of patients with complete response or partial response
Time Frame
Approximately 9 weeks following the first dose of study drug
Secondary Outcome Measure Information:
Title
Major pathological response rate
Description
The proportion of patients with pathological response in the resected tumor
Time Frame
Approximately 12 weeks following the first dose of study drug
Title
Pathological complete response rate
Description
The proportion of patients with pathological response rate in the resected tumor
Time Frame
Approximately 12 weeks following the first dose of study drug
Title
R0 resection rate
Description
The proportion of patients with R0 resection
Time Frame
Approximately 12 weeks following the first dose of study drugs
Title
Disease free survival
Description
The time from enrolment to disease recurrence or death, which ever comes first
Time Frame
Approximately 3 years following the first dose of study drugs
Title
Overall survival
Description
The time from enrolment to death of any reason
Time Frame
Approximately 5 years following the first dose of study drugs
Title
Pathological downstaging of lymph node rate
Description
The proportion of patients with pathological downstaging of lymph node rate
Time Frame
Approximately 12 weeks following the first dose of study drugs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
With written informed consent before any study procedure
Histology or cytology diagnose of non-small cell lung cancer within 60 days
Stage IIIA/IIIB, with resectable lesion(s) by radiology
EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
Without prior anti-tumor treatment
With at least one measurable lesions (The longest axis ≥10mm)
ECOG performance status 0-1
Using adequate and effective contraception, 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:
EGFR Exon 20 insertions positive
Mixed with small cell cancer, or other mixed types of lung cancer
Any prior anti-tumor treatment
Major surgery within 4 weeks before enrolment
Women with pregnancy or breastfeeding
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 history of other malignancy except for radical resected tumors without recurrence for 5 years or more
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
Severe gastrointestinal diseases which may affect the intake and absorption of study drug
Prolongation of ECG QTc or with relative risk factors
History of interstitial lung disease or with relative risk factors
Inadequate organ function of hematology, liver and kidney
Allergic to study drugs or any component
Poor adherence or other situation judged by investigator
Patients who had participated other clinical studies of tumors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Lei, MD
Phone
15094079004
Email
leijiemd@163.com
Facility Information:
Facility Name
Tangdu Hospital
City
Xi'an
State/Province
Shannxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Lei, MD
Phone
15094079004
Email
leijiemd@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIIA-IIIB Resectable NSCLC (FORESEE)
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