Non-small cell lung cancer
Conditions
Interventions
Cohort 1:Toripalimab combined with platinum?based doublet chemotherapy for 2–3 cycles, followed by toripalimab alone for 11–12 cycles.
Cohort 2:14 cycles of toripalimab
Sponsors
Chengdu Seventh People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years, both genders eligible; 2. Histologically or cytologically confirmed stage II–IIIB (AJCC 9th edition), EGFR/ALK wild-type, previously untreated NSCLC patients; 3. Failure to achieve pathological complete response (pCR) after 3 cycles of neoadjuvant chemoimmunotherapy followed by surgery; 4. ECOG performance status 0–1; 5. Presence of measurable disease per RECIST 1.1; 6. Life expectancy >= 3 months; 7. Adequate major organ function (within 14 days prior to enrollment), meeting the following criteria: Neutrophils >= 1.5×10^9/L, platelet count >= 100×10^9/L, hemoglobin >= 90 g/L; Serum creatinine = 50 mL/min; Total bilirubin <= 1.5×ULN, AST and ALT <= 2.5×ULN (in patients with liver metastases, ALT and AST <= 5×ULN); INR or PT <= 1.5×ULN unless the subject is receiving anticoagulant therapy, aPTT <= 1.5×ULN unless the subject is receiving anticoagulant therapy; 8. The subject or legal representative has been informed of the nature of the study, understands the protocol requirements, is able to comply with them, and has signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with histologically or cytologically confirmed small cell lung cancer; 2. Patients with advanced lung cancer, unresectable lung cancer, or prior systemic therapy (including systemic chemotherapy, targeted therapy, immunotherapy, etc.) for resectable NSCLC; 3. Patients with confirmed EGFR or ALK mutations; 4. Known hypersensitivity to recombinant humanized anti-PD-1 monoclonal antibody or any of its components; 5. Patients allergic to cisplatin, paclitaxel, nab-paclitaxel, pemetrexed, or other chemotherapeutic agents; 6. Patients with active pulmonary tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year prior to screening; 7. Uncontrolled or symptomatic hypercalcemia (calcium ion >1.5 mmol/L or calcium >12 mg/dL or corrected serum calcium > ULN); 8. Clinically uncontrolled active infections, including but not limited to acute pneumonia; 9. Uncontrolled major seizure disorder or superior vena cava syndrome; 10. Concurrent or prior other malignancies within the past 5 years (except for non-melanoma skin basal cell carcinoma or squamous cell carcinoma that has been curatively treated with no evidence of disease recurrence, carcinoma in situ of the breast/cervix, superficial bladder cancer, or other in situ cancers); 11. History of interstitial pneumonia, idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonia, evidence of active pneumonitis on screening chest CT scan, or other moderate to severe lung diseases that significantly affect pulmonary function; 12. Known human immunodeficiency virus (HIV) infection (known HIV antibody positive); 13. Severe cardiovascular disease, such as New York Heart Association (NYHA) class 2 or higher heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 6 months prior to enrollment; 14. Use of systemic immunosuppressive agents (i.e., corticosteroids or immunosuppressive drugs) for any active autoimmune disease within 2 years prior to study initiation; 15. Receipt of live virus vaccine within 4 weeks prior to study initiation; 16. Patients who have previously undergone allogeneic stem cell or solid organ transplantation; 17. Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; patients who are fertile but unwilling to use contraceptive measures, or whose sexual partners are unwilling to use contraceptive measures; 18. Any other clinically significant disease or condition that, in the investigator's opinion, may affect protocol compliance (e.g., history of psychiatric illness or substance abuse), preclude the patient from deriving benefit from the study, or affect the patient's ability to sign informed consent (e.g., drug abuse), or make the patient unsuitable for participation in this clinical study (including but not limited to: laboratory abnormalities, clinically active diverticulitis, intra-abdominal abscess, intestinal obstruction, peritoneal carcinomatosis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactRui Zhang
Chengdu Seventh People's Hospital
Outcome results
None listed