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

NCT ID: NCT05430802

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-24
• Study Completion Date: 2026-03-01

Brief 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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Furmonertinib+cisplating/pemetrexed

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tangdu Hospital

Xi'an, Shannxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Lei, MD

Role: CONTACT

leijiemd@163.com

15094079004

Facility Contacts

Jie Lei, MD

Role: primary

leijiemd@163.com

15094079004

Other Identifiers

PMR-21011

Identifier Type: -

Identifier Source: org_study_id