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

Lung Adenocarcinoma Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04965831
• Other study ID #: AST-PMR2003
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2021
• Est. completion date: May 1, 2026

Study information

• Verified date: June 2021
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Changli Wang, MD
• Phone: +86 022-23340123
• Email: aswindcc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Please refer to detailed description in the following context.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2026
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Lung Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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