Sintilimab, Anlotinib Hydrochloride and Platinum-Containing Dual-Agent Chemotherapy in NSCLC

- 1. Voluntary provision of informed consent.

- 2. Males or females aged 18-75.

- 3. Histological or cytologically confirmed NSCLC, metastatic or recurrent (stage IV), non-resectable or radical radio-chemotherapy locally advanced (stage IIIB-IIIC).

- 4. Not suitable for targeted therapy (patients with non-squamous NSCLC have no EGFR, ALK, or ROS1 gene mutation)

- 5. At least one lesion can be measured by imaging.

- 6. Have not received systemic treatment in the past.

- 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.

- 8. Life expectancy ≥ 3 months.

- 9. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.

- 1. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.

- 2. Received radiation therapy within 6 weeks.

- 3. Diagnosed with other malignant diseases other than NSCLC within 5 years.

- 4. Have participated in other interventional clinical research treatments now or within 4 weeks.

- 5. Have previously received targeted therapy.

- 6. Received Chinese patent medicines with anti-lung cancer indications or immunomodulatory drugs within 2 weeks.

- 7. Have active autoimmune diseases requiring systemic treatment within 2 years.

- 8. Received systemic glucocorticoid therapy or immunosuppressive therapy within 7 days.

- 9. Clinically uncontrollable pleural effusion/abdominal effusion.

- 10. Known allogeneic organ transplantation or hematopoietic stem cell transplantation.

- 11. Known to be allergic to study drug.

- 12. Have been vaccinated with the live vaccine within 30 days.

- 13. Pregnant or breastfeeding females.

- 14. Other serious hazards to the safety of patients.