Diagnosed as II-IIIB EGFR-positive mutant NSCLC through preoperative pathology and imaging
Conditions
Interventions
Intervention arm:Neoadjuvant therapy with almonertinib combined with pemetrexed disodium
Amitinib: Oral administration, once daily.
Pemetrexed: Administered by intravenous infusion, with each treatmen
Sponsors
Yuebei People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years. 2. Histopathologically confirmed non-squamous non-small cell lung cancer, with EGFR 19del or 21L858R sensitive mutation confirmed by tissue or blood genetic testing. 3. Clinical stage II-IIIB, with all lesions assessed as surgically resectable with curative intent (according to AJCC 8th edition staging); for stage III lung cancer, resectability must be evaluated by multidisciplinary team (MDT) discussion. 4. ECOG performance status 0-1, with no disease progression or deterioration at baseline or within 2 weeks before the first dose. 5. Adequate function of vital organs (heart, lung, liver, kidney, etc.) to meet the requirements of the study drug and anesthesia/surgery. Subjects must meet the following laboratory criteria: absolute neutrophil count (ANC) >=1.5×10^9/L; platelet count >=100×10^9/L; hemoglobin >90 g/dL; total bilirubin =60 mL/min; adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN. 6. Agree to provide tumor tissue from biopsy before neoadjuvant therapy and from surgical specimens, and to have 15 mL of venous blood collected within 3 days before the start of neoadjuvant therapy and within 3 days before surgery, for biomarker analysis. 7. Female of childbearing potential must have a negative pregnancy test within 7 days before the start of treatment and agree to use contraceptive measures during treatment and for 3 months after completion; male of reproductive potential must be surgically sterilized or agree to use contraceptive measures during treatment and for 3 months after completion. 8. At least one measurable lesion as assessed by the investigator according to RECIST version 1.1. 9. Understand and voluntarily sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pathological types of squamous cell carcinoma, small cell lung cancer, mixed pathological type lung cancer, large cell neuroendocrine carcinoma, or sarcomatoid carcinoma. 2. Predicted to be surgically unresectable or only potentially resectable. Specific criteria include: 1) tumor involvement, encasement, or invasion of major vessels, carina, or trachea; 2) multi-station fused N2 lymph node metastasis; 3) deemed unresectable after multidisciplinary team (MDT) discussion. 3. Patients with significant hemoptysis or assessed to have a high risk of bleeding. 4. Prior receipt of any systemic antitumor therapy before enrollment in this study, including chemotherapy, radiotherapy, immunotherapy (including but not limited to anti-PD-1, anti-PD-L1, anti-PD-L2, or drugs targeting another co-inhibitory T-cell receptor), or targeted therapy (including but not limited to monoclonal antibodies, small-molecule tyrosine kinase inhibitors, etc.). 5. Patients previously diagnosed with other malignancies. 6. History of interstitial lung disease, drug-induced interstitial disease, or any clinically active interstitial lung disease; presence of idiopathic pulmonary fibrosis on baseline CT scan. 7. Evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as judged by the investigator. 8. Any unstable systemic disease (including active infection, grade III hypertension, unstable angina, congestive heart failure, hepatic, renal, or metabolic disease). 9. Prior definite history of neurological or psychiatric disorders, including epilepsy or dementia. 10. Severe chronic or active infection requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection, etc. 11. Known active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, or other infectious diseases deemed unsuitable for enrollment. 12. Known severe allergy to the study drug and/or any of its excipients. 13. Pregnant or breastfeeding women. 14. Other conditions that, in the investigator's opinion, make the patient ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease control rate;Median maximum tumor shrinkage rate;R0 resection rate;Median event-free survival (mEFS);Median overall survival (mOS);Safety; | — |
Countries
China
Contacts
Public ContactChen Huiyong
Yuebei People’s Hospital
Outcome results
None listed