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

NCT06890182 | Not Yet Recruiting Phase 2

• 1 other identifier: E20250016
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pathological Complete Response Rate（pCR)

  Approximately 24 weeks following the first dose of study drug

• Objective Response Rate (ORR)

  Approximately 8 weeks following the first dose of study drug

• Rate of R0 Resection

  Approximately 16 weeks following the first dose of study drug

• Pathological downstaging of lymph node rate

  Approximately 16 weeks following the first dose of study drug

• Incidence of adverse events (AE)

  Approximately 12 weeks following the first dose of study drug

Study Arms (1)

Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed

EXPERIMENTAL

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

Interventions

Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed DRUG

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

Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Dual or multiple primary NSCLC
• Any prior anti-tumor treatment
• With history of other malignancy except for radical resected tumors without recurrence for 5 years or more
• 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
• 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
• Laboratory tests indicate insufficient bone marrow reserve or organ reserve
• Women with pregnancy or breastfeeding
• Patients with known or suspected drug allergies, or other contraindications
• Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
• Patients who are currently or previously enrolled in any other anti-tumor clinical study.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Cisplatin; 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)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; 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

Study Officials

• Zhansheng Jiang

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhansheng Jiang

CONTACT

13512035574; 18526812877@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: March 16, 2025
• First Posted: March 21, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03