Overview

A phase II study to assess the efficacy and safety of Surufatinib Combined With Toripalimab and Chemotherapy as a first-line treatment in patients with advanced non-squamous non-small cell lung cancer.

Eligibility

Inclusion Criteria:

1. Voluntary provision of informed consent.
2. Males or females aged 18-75.
3. Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ).
4. At least one lesion can be measured by imaging.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
6. Life expectancy ≥ 12 weeks.
7. None previous chemotherapy or targeted therapy(Arm:wild-type genotype).
8. Patients should be confirmed acquired EGFR T790M mutation and received adequate EGFR-TKI treatment(Arm:EGFR mutation).
9. Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment.

Exclusion Criteria:

1. Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
2. Diagnosed with other malignant diseases other than NSCLC within 5 years.
3. Have participated in other interventional clinical research treatments now or within 4 weeks.
4. Have previously received multi-targeted kinase inhibitors therapy.
5. Have active autoimmune diseases requiring systemic treatment within 2 years.
6. Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks.
7. Clinically uncontrollable pleural effusion/abdominal effusion.
8. Vaccinated vaccines or attenuated vaccines within 4 weeks before the group;
9. Pregnant or breastfeeding females.
10. Other serious hazards to the safety of patients.