Non-small cell lung cancer
Conditions
Interventions
Immunotherapy group: Tirellizumab: 200mg intravenously, once every 3 weeks, until no benefit is achieved or unacceptable toxicity occurs, or 2 years of treatment is completed.
Chemotherapy group :Single-agent chemotherapy: pemetrexed (500mg/m^2, D1, every 3 weeks) or paclitaxel (175mg/m^2, D1, every 3 weeks), 4-6 cycles, placebo. Patients are allowed to crossover to receive
Sponsors
Chongqing Jiulongpo People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with stage IIIB-IIIC and stage IV (AJCC 9th) unresectable NSCLC, or resectable but intolerant or refusing surgery; 2. Negative for epidermal growth factor receptor (EGFR) mutation and/or negative for anaplastic lymphoma kinase (ALK) mutation; 3. No prior systemic therapy for NSCLC; 4. At least one measurable lesion (based on RECIST 1.1 criteria); 5. Intolerant to platinum-based chemotherapy, such as ECOG PS: 2-3; or ECOG PS: 0-1 with concurrent contraindications to platinum-containing drugs or severe illnesses determined by the investigator; 6. Intolerant to radiotherapy or unwilling to receive radiotherapy; 7. Ssymptomatic brain metastases; 8. Age >= 18 years, and life expectancy >6 months; 9. Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose): 10. Be able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule.
Exclusion criteria
Exclusion criteria: 1.Patients with NSCLC carrying EGFR-sensitive mutations and ALK rearrangements; 2. Prior use of anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies (including ipilimumab or any other antibody specifically targeting T-cell costimulation or checkpoint pathways); 3. Known history of allergy to any drug component in this study regimen; 4. Any active malignancy =10mg/day of prednisone or equivalent doses of other steroids) or other immunosuppressants, where the investigator assesses that it may impact the study protocol; 11. Uncontrolled significant cardiovascular diseases; history of clinically significant QT interval prolongation or QTc interval >480 ms during screening; 12. Renal dysfunction (serum creatinine >1.5 times the upper limit of normal); 13. There are concomitant diseases that pose a serious risk to patient safety or affect the patient's ability to complete the study (e.g., severe hypertension, diabetes, thyroid disease, active infections, etc.); 14. A history of definite neurological or psychiatric disorders, including epilepsy or dementia; 15. Unsuitable for participation in this study; 16. Concurrent participation in other clinical studies; 17. Mixed lung cancer with small cell lung cancer (SCLC).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, Progressive free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, Objective response rate;OS; | — |
Countries
China
Contacts
Public ContactRan Sun
Chongqing Jiulongpo People's Hospital
Outcome results
None listed