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

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Adenocarcinoma
• Intervention / Treatment: Drug: Furmonertinib

Detailed Description

Please refer to detailed description in the following context.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Changli Wang, MD; Phone Number: +86 022-23340123; Email: aswindcc@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Proportion of patients whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1	Approximately 8 weeks following the first dose of study drug

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating tumor DNA clearance rate	The proportion of patients with circulating tumor DNA clearance after neoadjuvant therapy	Approximately 8 weeks following the first dose of study drug
Minimal residual disease rate	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	Approximately 12 weeks following the first dose of study drug

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Allist Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Changli Wang, MD, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 16, 2021

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Aflutinib
• Other Study ID Numbers: AST-PMR2003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD sharing plan is not to be shared according to the policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No