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

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Mar 16, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with resectable stage II to IIIB non-small cell lung cancer (NSCLC) that has specific mutations in a gene called EGFR. The treatment combines a medication called firmonertinib with standard chemotherapy drugs (carboplatin, cisplatin, and pemetrexed) before surgery to see if this combination works better than standard treatments alone. The trial is currently not recruiting participants, but it aims to find out how safe and effective this new treatment is for eligible patients.

To qualify for the study, participants must be at least 18 years old, have a confirmed diagnosis of NSCLC with certain EGFR mutations, and be in good overall health without significant recent health issues. They should also have a measurable tumor and have not received any previous cancer treatments. During the trial, participants can expect to receive the study medication along with chemotherapy before their surgery, and they will be closely monitored for any side effects and how well the treatment works. It's important to note that women who are pregnant or breastfeeding cannot participate, and additional health criteria will be considered to ensure safety throughout the study.

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Eligibility criteria

• 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.