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

Li Zhang, MD

Status and phase: Enrolling; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05003037

HMPL-012-SPRING-L102

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Wild-type Genotype

Experimental group

Treatment:

Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin

EGFR mutation

Experimental group

Treatment:

Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin