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

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

In this single-arm, phase II clinical trial, patients with resectable, EGFR-mutated, stage II-IIIB NSCLC received neoadjuvant therapy with furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 3 cycles. Surgery was performed 4-6 weeks after chemotherapy. The primary endpoint was objective response rate (ORR). Secondary endpoints included the pathological complete response (pCR) rate, major pathological response (MPR) rate, TNM downstaging rate, R0 resection rate, EFS, overall survival (OS), drug safety and surgical complications.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Furmonertinib+cisplating/pemetrexed

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

Contacts and Locations

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China
      • Tangdu Hospital

Participation Criteria

Eligibility Criteria

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

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 IIA-IIIB (T3N2M0 only), 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
• 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 enrollment
• Women with pregnancy or breastfeeding
• Use of strong CYP3A4 inhibitors within 7 days or strong CYP3A4 inducers within 21 days before enrollment; use of traditional Chinese medicine with anti-tumor effect within 21 days before enrollment
• 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 platinum-based doublet chemotherapy; furmonertinib (oral, 80 mg once daily, stopped 1 week preoperatively) in combination with platinum-based doublet chemotherapy every 3 weeks for a total of 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 achieving complete response (CR) or partial response (PR) as assessed by investigators according to RECIST version 1.1	7 days before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The time from enrolment to death of any reason	Approximately 5 years following the first dose of study drugs
Major pathological response rate	MPR was defined as the presence of ≤10% residual viable tumor cells in the primary tumor and all lymph nodes from surgical specimens following R0 resection, and the MPR rate was subsequently calculated as the proportion of patients who achieved MPR	7 days after surgery
Pathological complete response rate	pCR was defined as the absence of viable tumor cells in the primary tumor and all sampled regional lymph nodes from surgical specimens following R0 resection, and the pCR rate was calculated as the proportion of patients achieving this response	7 days after surgery
R0 resection rate	the proportion of patients achieving R0 resection among all patients undergoing tumor resection surgery	7 days after surgery
the TNM downstaging rate	defined as the proportion of patients whose post-neoadjuvant therapy TNM stage (prior to surgery) was lower than their baseline TNM stage	7 days before surgery
Event-free survival	defined as the time from the date of informed consent to loss of surgical eligibility due to disease progression, postoperative recurrence, or death from any cause	2 years
drug safety and surgical complications	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 and Number of participants with surgical complications as assessed by Clavien-Dindo	Adverse events (AEs) will be followed up for 30 days, serious adverse events (SAEs) will be followed up until resolution (assessed up to 60 days), and surgical complications will be followed up for 90 days.

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): September 1, 2025
• Study Completion (Estimated): December 1, 2029

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): August 11, 2026
• Last Update Submitted That Met QC Criteria: August 7, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: furmonertinib; AST2818
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; 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