Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)
Primary Purpose
Lung Adenocarcinoma
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Furmonertinib
Sponsored by
About this trial
This is an interventional treatment trial for Lung Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study.
- Primary lung adenocarcinoma diagnosed histologically/cytologically.
- Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators.
- EGFR mutation positive (19Del or L858R, with or without T790M)
- The presence of at least one measurable lesion and suitable for accurate repeated measurements.
- ECOG performance status 0-1.
- For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.
Exclusion Criteria:
- Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma.
- Patients with EGFR exon 20 insertion mutation.
- Exposure to other antitumor therapies prior to enrolment.
- Major surgery was performed in the four weeks prior to the first dosing of the study drug.
- Pregnant or lactating female patients.
- Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration.
- Have a history of or present complications with other malignancies.
- Patients with severe or uncontrolled systemic disease requiring treatment were not considered suitable for the study.
- ECG QT interval prolongation or associated risk.
- A history of interstitial pneumonia or related risk.
- Inadequate bone marrow or organ reserve.
- Other circumstances that are not suitable for participation in this study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Furmonertinib
Arm Description
Furmonertinib as perioperation therapy
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1
Secondary Outcome Measures
Disease Control Rate (DCR)
Proportion of patients whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1
Progression free survival (PFS)
The time from the first does of the study drugs to the progression of the disease or death for any reason.
Disease free survival (DFS)
The time from the end of surgery to the progression of the disease or death for any reason.
Adverse Events (AEs)
The number of patients with adverse events and the severity according to CTCAE v5.0
Full Information
NCT ID
NCT04965831
First Posted
June 27, 2021
Last Updated
July 8, 2021
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Allist Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04965831
Brief Title
Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)
Official Title
Furmonertinib Mesylate as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable, EGFR Sensitizing Mutation Positive Lung Adenocarcinoma Patients: A Phase II, Single-arm, Open-label Clinical Study (FRONT)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
May 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Allist Pharmaceuticals, Inc.
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
This is a phase II study aimed to assess the efficacy and safety of furmonertinib, a third generation EGFR TKI, as perioperation therapy in stage IIIA-IIIB (N1-N2) resectable NSCLC patients.
Detailed Description
Please refer to detailed description in the following context.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma
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
Arm Type
Experimental
Arm Description
Furmonertinib as perioperation therapy
Intervention Type
Drug
Intervention Name(s)
Furmonertinib
Other Intervention Name(s)
AST2818
Intervention Description
Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1
Time Frame
Approximately 8 weeks following the first dose of study drug
Secondary Outcome Measure Information:
Title
Disease Control Rate (DCR)
Description
Proportion of patients whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1
Time Frame
Approximately 8 weeks following the first dose of study drug
Title
Progression free survival (PFS)
Description
The time from the first does of the study drugs to the progression of the disease or death for any reason.
Time Frame
Approximately 3 years following the first dose of study drug
Title
Disease free survival (DFS)
Description
The time from the end of surgery to the progression of the disease or death for any reason.
Time Frame
Approximately 3 years following the first dose of study drug
Title
Adverse Events (AEs)
Description
The number of patients with adverse events and the severity according to CTCAE v5.0
Time Frame
From the start of study drug to 28 days after the last dose of study drug
Other Pre-specified Outcome Measures:
Title
Circulating tumor DNA clearance rate
Description
The proportion of patients with circulating tumor DNA clearance after neoadjuvant therapy
Time Frame
Approximately 8 weeks following the first dose of study drug
Title
Minimal residual disease rate
Description
The proportion of patients with minimal residual disease defined as detectable ctDNA with a variant allele fraction of at least 0.1% in plasma after surgery
Time Frame
Approximately 12 weeks following the first dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The written informed consent of the patients has been obtained before any examination, sampling and analysis related to the study.
Primary lung adenocarcinoma diagnosed histologically/cytologically.
Stages IIIA-IIIB (N1-N2) according to the AJCC 8th edition lung cancer stage and plan to receive radical excision judged by investigators.
EGFR mutation positive (19Del or L858R, with or without T790M)
The presence of at least one measurable lesion and suitable for accurate repeated measurements.
ECOG performance status 0-1.
For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.
Exclusion Criteria:
Squamous cell carcinoma, and tumors with neuroendocrine components such as large cell carcinoma, or small cell carcinoma.
Patients with EGFR exon 20 insertion mutation.
Exposure to other antitumor therapies prior to enrolment.
Major surgery was performed in the four weeks prior to the first dosing of the study drug.
Pregnant or lactating female patients.
Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration.
Have a history of or present complications with other malignancies.
Patients with severe or uncontrolled systemic disease requiring treatment were not considered suitable for the study.
ECG QT interval prolongation or associated risk.
A history of interstitial pneumonia or related risk.
Inadequate bone marrow or organ reserve.
Other circumstances that are not suitable for participation in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Changli Wang, MD
Phone
+86 022-23340123
Email
aswindcc@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changli Wang, MD
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The IPD sharing plan is not to be shared according to the policy.
Learn more about this trial
Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)
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