Furmonertinib as Perioperation Therapy in Stage IIIA-IIIB (N1-N2) Resectable EGFR Mutated Lung Adenocarcinoma (FRONT)

Sponsor

Tianjin Medical University Cancer Institute and Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04965831

Collaborator

Allist Pharmaceuticals, Inc. (Industry)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Adenocarcinoma	Drug: Furmonertinib	Phase 2

Detailed Description

Please refer to detailed description in the following context.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Furmonertinib Furmonertinib as perioperation therapy	Drug: Furmonertinib Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery. Other Names: AST2818

Arm

Intervention/Treatment

Experimental: Furmonertinib

Furmonertinib as perioperation therapy

Drug: Furmonertinib

Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery.

Other Names:

AST2818

Outcome Measures

Primary Outcome Measures

Objective Response Rate (ORR) [Approximately 8 weeks following the first dose of study drug]
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) [Approximately 8 weeks following the first dose of study drug]
Proportion of patients whose tumors were assessed as CR, PR or stable disease (SD) according to RECIST 1.1
Progression free survival (PFS) [Approximately 3 years following the first dose of study drug]
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) [Approximately 3 years following the first dose of study drug]
The time from the end of surgery to the progression of the disease or death for any reason.
Adverse Events (AEs) [From the start of study drug to 28 days after the last dose of study drug]
The number of patients with adverse events and the severity according to CTCAE v5.0

Other Outcome Measures

Circulating tumor DNA clearance rate [Approximately 8 weeks following the first dose of study drug]
The proportion of patients with circulating tumor DNA clearance after neoadjuvant therapy
Minimal residual disease rate [Approximately 12 weeks following the first dose of study drug]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tianjin Medical University Cancer Institute and Hospital
Allist Pharmaceuticals, Inc.

Investigators

Principal Investigator: Changli Wang, MD, Tianjin Medical University Cancer Institute and Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tianjin Medical University Cancer Institute and Hospital

ClinicalTrials.gov Identifier:

NCT04965831

Other Study ID Numbers:

AST-PMR2003

First Posted:

Jul 16, 2021

Last Update Posted:

Jul 16, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Adenocarcinoma of Lung

Aflutinib

Study Results

No Results Posted as of Jul 16, 2021