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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430802
• Other study ID #: PMR-21011
• Status: Recruiting
• Phase: Phase 2
• Start date: February 24, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: June 2022
• Source: Tang-Du Hospital
• Contact: Jie Lei, MD
• Phone: 15094079004
• Email: leijiemd[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	The proportion of patients with complete response or partial response	Approximately 9 weeks following the first dose of study drug
Secondary	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
Secondary	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
Secondary	R0 resection rate	The proportion of patients with R0 resection	Approximately 12 weeks following the first dose of study drugs
Secondary	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
Secondary	Overall survival	The time from enrolment to death of any reason	Approximately 5 years following the first dose of study drugs
Secondary	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