Non small cell lung cancer
Conditions
Interventions
single arm: Tislelizumab plus chemotherapy
Sponsors
Jiansu Cancer Hospital
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >= 70 years old male or female; 2. The patients are diagnosed as non-small cell lung cancer via histologic and cytology (according to V8.0 IASLC); 3. Clinical stage is stage IV(according to V8.0 AJCC); 4. Have one measurable lesions at least according to RECIST 1.1 standard; 5. ECOG PS 0-1; 6. The expected lifetime of patients should be more than 3 months; 7. No previous systematic antitumor therapy (including EGFR or ALK inhibitors or ROS1 inhibitors); 8. Biochemical examination should meet the following criteria: a. TBIL = 40ml/min; 9. The main viscera function of patients should meet the following requirements: a. HB >= 9.0g/dL; b. ANC >= 1.5 x 10^9/L; c. PLT >= 100 x 10^9/L. 10. The patients are willing to join in this study, and have signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are diagnosed with small cell lung cancer or tumors with mixed histology, including the SCLC complex; 2. Known EGFR driver gene positive or HER2 exon embedding; 3. ALK or ROS1 gene rearrangement was found by IH, FISH or NGS sequencing; 4. The patient had previous or active cancer in the past 3 years, except for those with negligible risk of metastasis or death and treated with expected outcome (e.g., carcinoma in situ of the cervix); 5. Previous systemic therapy (including, but not limited to, chemotherapy, targeted therapy, immunotherapy, and any of the research drugs in this study), with the exception of adjuvant therapy for more than 5 years; 6. A history of severe allergies, allergies or other allergic reactions to chimeric or humanized antibodies or fusion proteins; 7. Severe autoimmune disease; 8. Symptomatic brain metastases; 9. Uncontrollable tumor-related pain; 10. Hypercalcemia that is uncontrolled, symptomatic, or requiring decalcification; 11. Immunosuppressive drugs were administered 2 weeks prior to enrollment; 12. Oral dosage of more than 10mg of prednisone or isodose hormone per day; 13. Severe infections requiring antimicrobial treatment 2 weeks prior to enrollment; 14. Severe pulmonary dysfunction before enrollment; 15. Severe comorbidity precludes the possibility of treatment; 16. Other conditions considered inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;Safty; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;DOR;QoL; | — |
Countries
China
Contacts
Public ContactShen Bo
Jiangsu Cancer Hospital
Outcome results
None listed