EGFR Sensitive Mutated Stage II-IIIB NSCLC
Conditions
Interventions
The neoadjuvant treatment group of firmonertinib combined with chemotherapy and SBRT.:firmonertinib at 80 mg/day, administered orally, planned for three treatment cycles (each lasting three weeks).
Pl
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>= 18 years old, male or female; 2. Histologically confirmed resectable or potentially resectable treatment-naive stage II-IIIB NSCLC; 3. Molecularly diagnosed EGFR sensitive mutations (19Del and 21L858R); 4. At least one measurable lesion per RECIST v1.1; 5. No prior systemic antitumor therapy; 6. Pulmonary function tests within the last 3 months showing FEV1>1.2L and FEV1%>40%; 7. Laboratory tests suggesting that the subject has adequate organ function: including: 1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; platelet count (PLT)>= 100 x 10^9/L; hemoglobin (HGB) >= 90 g/L; 2) Serum total bilirubin (TBIL) =50 ml/min (according to the Cockcroft-Gault formula); 8. ECOG PS 0-1 at screening; 9. Women of childbearing potential must have a negative pregnancy test within 7 days before treatment and use reliable contraception during and for 30 days after the study. Men of childbearing potential must use condoms during and for 30 days after the study; 10. Life expectancy >6 months; 11. For patients planned to receive cisplatin: no hearing impairment; 12. Understanding and willingness to participate in the study, with signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with small cell lung cancer or neuroendocrine carcinoma identified by histopathological or cytological examination; 2. Patients with other driver gene positives; 3. Patients who have received systemic anti-cancer treatment for non-small cell lung cancer, including surgery, local radiotherapy, cytotoxic drug treatment, targeted drug treatment, etc.; 4. Use of strong CYP3A4 inhibitors or inducers for a long time within 7 days before the first dose or expected during the trial; 5. Patients receiving treatment with drugs known to prolong the QTc interval or potentially cause torsades de pointes; 6. History of other malignancies, or presence of other malignancies (except for those that have been treated radically and have not recurred for 5 years after surgery, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma, etc.); 7. History of interstitial lung disease (ILD), drug-induced interstitial lung disease, steroid-treated radiation pneumonitis, or patients with clinical manifestations suggestive of interstitial lung disease; 8. Patients with severe or uncontrolled systemic diseases requiring treatment, who are considered by the investigator as unsuitable for participation in the trial; 9. Severe gastrointestinal dysfunction that may affect the intake, transport, or absorption of the study drug; 10. Patients with infectious diseases requiring intravenous drug treatment; 11. Patients with a known history of mental illness or drug addiction that is currently active or ongoing; 12. Patients receiving treatment with P-glycoprotein inhibitors; 13. Pregnant or breastfeeding women, or female subjects planning to become pregnant during the study, or female partners of male subjects; 14. Poor compliance of the subjects who cannot adhere to the various processes, restrictions, or requirements of the study; 15. Other situations where the investigator considers the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major Pathological Response (MPR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-Free Survival;Pathological Complete Response (pCR) Rate;Objective Response Rate(ORR);Overall Survival (OS);Safety outcomes; | — |
Countries
China
Contacts
Public ContactFeng Yao
Shanghai Chest Hospital
Outcome results
None listed