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

NCT05430802 | Recruiting Phase 2

• 1 other identifier: PMR-21011
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

furmonertinib; AST2818

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Major pathological response rate

  7 days after surgery

• Pathological complete response rate

  7 days after surgery

• R0 resection rate

  7 days after surgery

• the TNM downstaging rate

  7 days before surgery

• Event-free survival

  2 years

Study Arms (1)

furmonertinib plus platinum-based doublet chemotherapy

EXPERIMENTAL

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

Interventions

Furmonertinib+cisplating/pemetrexed DRUG

Furmonertinib 80mg/d for 9 weeks and cisplating75mg/m2 d1 iv + pemetrexed 500mg/m2 d1 iv in 21-day cycles for 3 cycles

furmonertinib plus platinum-based doublet chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital

Xi'an, Shannxi, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Jie Lei, MD

CONTACT

15094079004; leijiemd@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: February 24, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)