Neoadjuvant Furmonertinib and Cisplatin/Pemetrexed as in EGFR Mutated Stage IIIA-IIIB Resectable NSCLC (FORESEE)

Furmonertinib Combined With Cisplatin/Pemetrexed as Neoadjuvant Therapy in EGFR Mutated Stage IIIA-IIIB Resectable Non-small Cell Lung Cancer (FORESEE): a Prospective, Open-label, Single-arm, Phase 2 Study

In this open-label, single-arm, phase 2 study, 40 eligible patients with EGFR mutated stage IIIA-IIIB resectable NSCLC will be recruited to receive furmonertinib for 9 weeks combined with cisplatin/pemetrexed for 3 cycles (21 d/cycle) as neoadjuvant therapy before radical surgery. Radiological and pathological evaluations will be performed before and after the neoadjuvant therapy to assess the efficacy of treatment. Adverse events during neoadjuvant therapy, disease and survival status will also be collected in the study.

Study Overview

• Status: Recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Furmonertinib+cisplating/pemetrexed

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

Contacts and Locations

• Study Contact: Name: Jie Lei, MD; Phone Number: 15094079004; Email: leijiemd@163.com

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China
      • Recruiting
      • Tangdu Hospital
      • Contact: Jie Lei, MD; Phone Number: 15094079004; Email: leijiemd@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• With written informed consent before any study procedure
• Histology or cytology diagnose of non-small cell lung cancer within 60 days
• Stage IIIA/IIIB, with resectable lesion(s) by radiology
• EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
• Without prior anti-tumor treatment
• With at least one measurable lesions (The longest axis ≥10mm)
• ECOG performance status 0-1
• Using adequate and effective contraception, women should refrain from breastfeeding and have a negative pregnancy test prior to the first administration of the study drug if within during child-bearing age

Exclusion Criteria:

• EGFR Exon 20 insertions positive
• Mixed with small cell cancer, or other mixed types of lung cancer
• Any prior anti-tumor treatment
• Major surgery within 4 weeks before enrolment
• Women with pregnancy or breastfeeding
• Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrolment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrolment
• With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
• With severe or uncontrolled systemic disease such as uncontrolled hypertention, diabetes mellitus, chronic heart failure, unstable angina, myocardial infarction within 1 year, active hemorrhage, active HBV/HCV/HIV or other infections requiring infusion treatment
• Severe gastrointestinal diseases which may affect the intake and absorption of study drug
• Prolongation of ECG QTc or with relative risk factors
• History of interstitial lung disease or with relative risk factors
• Inadequate organ function of hematology, liver and kidney
• Allergic to study drugs or any component
• Poor adherence or other situation judged by investigator
• Patients who had participated other clinical studies of tumors

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 plus cisplatin/pemetrexed; furmonertinib 80mg/d for 9 weeks and cisplatin 75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv at 21 day cycles for 3 cycles	Drug: Furmonertinib+cisplating/pemetrexed; Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	The proportion of patients with complete response or partial response	Approximately 9 weeks following the first dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major pathological response rate	The proportion of patients with pathological response in the resected tumor	Approximately 12 weeks following the first dose of study drug
Pathological complete response rate	The proportion of patients with pathological response rate in the resected tumor	Approximately 12 weeks following the first dose of study drug
R0 resection rate	The proportion of patients with R0 resection	Approximately 12 weeks following the first dose of study drugs
Disease free survival	The time from enrolment to disease recurrence or death, which ever comes first	Approximately 3 years following the first dose of study drugs
Overall survival	The time from enrolment to death of any reason	Approximately 5 years following the first dose of study drugs
Pathological downstaging of lymph node rate	The proportion of patients with pathological downstaging of lymph node rate	Approximately 12 weeks following the first dose of study drugs

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: furmonertinib; AST2818
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Folic Acid Antagonists; Pemetrexed
• Other Study ID Numbers: PMR-21011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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