Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2025-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Li Zhang, MD
• Treatments: Carboplatin; Pemetrexed

Criteria

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.