Stage III unresectable non-small cell lung cancer
Conditions
Interventions
EGFR group:Befotertinib
Other driven mutation group:Iruplinalkib/Ensartinib/Bozitinib
Driven mutation negative, PD-L1 positive or driven mutation negative, PD-L1 negative, TIL high expression group:Toripalimab+chemotherapy
Driven mutation negative, PD-L1 negative, TIL low expression group:Adebrelimab+SHR-A1921
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Histologically or cytologically confirmed NSCLC; 3. Previously untreated NSCLC including local treatment (surgery or radiotherapy) and systemic anticancer therapy including chemotherapy, targeted therapy (TKI or monoclonal antibody), cell therapy, immunotherapy, Chinese medicine therapy and others; 4. Unresectable stage III NSCLC confirmed according to the 9th TNM classification of AJCC (T1-4N2-3M0) and evaluated by MDT. (Single N2 >3cm, or multiple N2 stations or multiple N2 >2cm, or N3 disease, detected by CT or PETCT should be confirmed by biopsy, mediastinoscopy or endobronchial ultrasonography); 5. Sufficient tumor tissue (not cytology specimens) available for molecular marker analyses (NGS and IHC); 6. At least one measurable lesion on spiral CT/PETCT according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); 7. Eastern Cooperative Oncology Group (ECOG) Zubrod Performance Status (ZPS) 0-1 point; 8. Patients should be tolerance of conversion therapy and thoracic surgery, and pulmonary ventilation function should be FEV1>=1.2L or anticipated FEV1 >= 800ml. Radical resection and systemic lymph node dissection are recommended; 9. Good hematopoietic function, which is defined as the absolute neutrophil count =1.5 × 109/L, the platelet count =100*10^9/L, the haemoglobin =9.0 g/dL; 10. Good liver function, which is defined as the total bilirubin =1.5 times of ULN, AST and ALT =2.5 times of ULN; 11. Good kidney function, which is defined as the serum creatinine =1.25 times of ULN or creatinine clearance=60ml/min (Cockcroft-Gault), protein in the urine 6 months 15. Informed consent signed by patients or legal representatives;
Exclusion criteria
Exclusion criteria: 1. T4 invasion to aorta, esophagus, heart, and/or other organs; T4 tumor with lung metastasis; 2. Bulky lymph node or multiple lymph nodes invasion to aorta, esophagus, heart, and/or other organs; 3. T1N2a stage according to the 9th TNM classification of AJCC; 4. Resectable or potentially resectable stage III NSCLC according to the 9th TNM classification of AJCC; ? cT1-2N2 (IIIA) Non bulky and non invasive single N2, or non bulky and non invasive multiple N2; ? cT4N0-1(IIIA) T4 only size >7 cm; ? cT3-4N2 (IIIB) Non bulky and non invasive single N2, or non bulky and non invasive limited discrete multiple N2 after selection; 5. Mixed small cell lung cancer patients; 6. Previous history with PD-1/PD-L1 treatment or other T cell targeted therapy (CTLA-4 OX-40); 7. Previous history of severe anaphylaxis for other monoclonal antibodies; 8. Previous history of severe anaphylaxis for Pemetrexed, Paclitaxel, Docetaxel, Cisplatin, Carboplatin or other Prophylactic medications; 9. Other malignancy within 5 years apart from NSCLC; except from: previous malignancy received curative treatment 2 years before the first time of study drug treatment and previous malignancy is no active disease and low recurrence risk; skin cancer (not melanoma) or freckled nevus malignancy received full treatment and had no disease evidence; carcinoma in situ received full treatment and had no disease evidence; 10. Any unstable systemic diseases, including active infection, uncontrolled hypertension (Systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg, even after best medicine treatment), unstable angina, angina attack within 3 months, liver, kidney or metabolism diseases needed medicine treatments; 11. Cardiac function and diseases including as following: ? Arrhythmia with clinical significance decided by researchers, obvious abnormalty, Including but not limited to Complete left bundle branch conduction abnormality, II. Degree of atrioventricular block ? ECG test, QTc =450ms(male), QTc =470ms(female),; ? NYHA = grade 3 or cardiac ultrasound: LEVF<50%; ? Myocardial infarction within one year; 12. Non-infectious pneumonia history needed glucocorticoids within one year before the first time drug treatment or Interstitial lung disease that currently exists; 13. HIV infection; 14. Active hepatitis B without treatment; except: a. HBV viral load <500 IU/ml or <1000 copy/ml before the first time drug treatment, anti-HBV treatment could be decided by researchers during clinical trial; b. Patients with anti-HBc(+), HBsAg(-), anti-HBs(-) and HBV viral load (-), preventive anti-HBV treatment is not required, but close surveillance for the viral reactivity is needed; 15. Active HCV patients (HCV antibody (+) and the level of HCV-RNA is higher than the lower limit of detection); 16. Drug allergies (the situation of drug allergies is confirmed according to the different subgroups in the clinical trial); 17. Severe surgery or severe damage happened within 2 months before the first time drug treatment; 18. Haemorrhage or obvious haemorrhagic tendency with clinical significance within 1 month before the first time drug treatment, such as gastrointestinal haemorrhage, gastric ulcer haemorrhage, or vasculitis; 19. Female wiith pregnancy or lactation; 20. Received organ or blood transplantation; 21. Unfit for study enrollment by clinical researchers, such as nervous or metabolism disorders, potential diseases suspected by physical examinations or laboratory tests, cont
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year event-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year event-free survival rate;2-year overall survival rate;5-year overall survival rate;The conversion rate of surgery;Life quality score ;Perioperative outcomes;Pathological response rate;Safety outcomes; | — |
Countries
China
Contacts
Public ContactWentao Fang
Department of thoracic surgery, Shanghai Chest Hospital
Outcome results
None listed