Menu
Not yet recruiting NCT06890182

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

Phase II Interventional Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Firmonertinib combined with Carboplatin/Cisplatin and Pemetrexed.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • 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

Primary outcome measures

  • Major pathological response rate (MPR) [Time frame: Approximately 24 weeks following the first dose of study drug]
Secondary outcome measures (5)
  • Pathological Complete Response Rate（pCR) [Time frame: Approximately 24 weeks following the first dose of study drug]
  • Objective Response Rate (ORR) [Time frame: Approximately 8 weeks following the first dose of study drug]
  • Rate of R0 Resection [Time frame: Approximately 16 weeks following the first dose of study drug]
  • Pathological downstaging of lymph node rate [Time frame: Approximately 16 weeks following the first dose of study drug]
  • Incidence of adverse events (AE) [Time frame: Approximately 12 weeks following the first dose of study drug]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06890182 · E20250016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗