Firmonertinib Combined With Chemotherapy as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutanted NSCLC

Firmonertinib Combine With Carboplatin/Cisplatin and Pemetrexed as Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢB EGFR Sensitive Mutanted NSCLC

This is a phase II study aimed to assess the efficacy and safety of firmonertinib combined with carboplatin/cisplatin and pemetrexed as neoadjuvant therapy in stage II-IIIB resectable NSCLC patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed

Detailed Description

In this open-label, single-arm, phase 2 study, 31 eligible patients with EGFR mutated stage IIIA-IIIB resectable NSCLC will be recruited to receive firmonertinib for 12 weeks combined with carboplatin/cisplatin and pemetrexed for 4 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 Type: Interventional
• Enrollment (Estimated): 31
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhansheng Jiang; Phone Number: 13512035574; Email: 18526812877@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provide informed consent prior to any study specific procedures
2. at least 18 years of age
3. Histology or cytology diagnose of non-small cell lung cancer within 60 days
4. ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks
5. Stage II-IIIB NSCLC that is expected to be resectable, as assessed by the investigator (8 thUICCTNM staging),
6. According to RECIST 1.1, patients have at least one measureable tumor lesion (The longest axis ≥10mm)
7. EGFR mutation positive (exon 19 deletions or exon 21 L858R, with or without other EGFR mutations)
8. Without prior anti-tumor treatment
9. Withe adequate organ function of hematology, liver and kidney
10. Using adequate and effective contraception, Male patients should be use condoms; 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:

1. Dual or multiple primary NSCLC
2. Any prior anti-tumor treatment
3. With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
4. Diseases or clinical states with severe abnormalities of gastrointestinal function that may interfere with the ingestion, transit, or absorption of the study drug.e.g., inability to take medication orally, uncontrolled nausea and vomiting
5. 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
6. Laboratory tests indicate insufficient bone marrow reserve or organ reserve
7. Women with pregnancy or breastfeeding
8. Patients with known or suspected drug allergies, or other contraindications
9. Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
10. Patients who are currently or previously enrolled in any other anti-tumor clinical study.

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: Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed; furmonertinib 80mg/d for 12 weeks and carboplatin AUC5 d1 iv / cisplatin 75mg/m2 d1 iv+ pemetrexed 500mg/m2 d1 iv at 21 day cycles for 4 cycles	Drug: Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed; furmonertinib 80mg/d for 12 weeks and carboplatin AUC5 d1 iv / cisplatin 75mg/m2 d1 iv+ pemetrexed 500mg/m2 d1 iv at 21 day cycles for 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major pathological response rate (MPR)	Proportion of resected specimens with ≤10% residual tumor cells assessed by surgical specimen pathology	Approximately 24 weeks following the first dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response Rate（pCR)	The proportion of patients with pathological response rate in the resected tumor.	Approximately 24 weeks following the first dose of study drug
Objective Response Rate (ORR)	According to RECIST 1.1 criteria, after 8 weeks of neoadjuvant therapy CT scans scans assessed the proportion of patients in partial and complete remission.	Approximately 8 weeks following the first dose of study drug
Rate of R0 Resection	The proportion of patients with R0 resection.	Approximately 16 weeks following the first dose of study drug
Pathological downstaging of lymph node rate	The proportion of patients with pathological downstaging of lymph node rate	Approximately 16 weeks following the first dose of study drug
Incidence of adverse events (AE)	The number of patients with adverse events and the severity according to CTCAE v5.0	Approximately 12 weeks following the first dose of study drug

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Principal Investigator: Zhansheng Jiang, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 16, 2025
• First Submitted That Met QC Criteria: March 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• 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; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Pemetrexed; Carboplatin
• Other Study ID Numbers: E20250016

Drug and device information, study documents

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