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

Phase 2

Not yet recruiting

• Conditions: Lung Adenocarcinoma
• Interventions: Drug: Furmonertinib

• Registration Number: NCT04965831
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

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.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-08
• Last Update Submitted: 2021-07-08
• Study First Posted: 2021-07-16
• Last Update Posted: 2021-07-16
• Study Start: 2021-08-01
• Primary Completion: 2023-03-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Furmonertinib	Furmonertinib	Furmonertinib as perioperation therapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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