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

Study Overview
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Brief Summary
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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.

Official Title
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A Open-label, Single Center, Phase II Study of Surufatinib Combined With Toripalimab and Chemotherapy in Patients With Advanced Non-squamous Non-small-cell Lung Cancer

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary provision of informed consent. Males or females aged 18-75. Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ). At least one lesion can be measured by imaging. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1. Life expectancy ≥ 12 weeks. None previous chemotherapy or targeted therapy(Arm:wild-type genotype). Patients should be confirmed acquired EGFR T790M mutation and received adequate EGFR-TKI treatment(Arm:EGFR mutation). Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrolment. Exclusion Criteria: Histological or cytologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC. Diagnosed with other malignant diseases other than NSCLC within 5 years. Have participated in other interventional clinical research treatments now or within 4 weeks. Have previously received multi-targeted kinase inhibitors therapy. Have active autoimmune diseases requiring systemic treatment within 2 years. Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks. Clinically uncontrollable pleural effusion/abdominal effusion. Vaccinated vaccines or attenuated vaccines within 4 weeks before the group; Pregnant or breastfeeding females. Other serious hazards to the safety of patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wild-type Genotype<br> | Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin<br>* Surufatinib at the dose determined in phase safety lead-in，250 mg，qd，po，every 3 weeks(q3w) ; Toripalimab at the dose 240mg，iv, d1, given every 3 weeks (q3w); Pemetrexed at the dose 500 mg/m2，iv，d1，given every 3 weeks (q3w); Carboplatin at the dose AUC=5 6，iv，d1，given every 3 weeks (q3w) or Cisplatin at the dose 75 mg/m2，iv ,d1，q3w; Maintenance treatment：After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D，d1-21，q3w＋Toripalimab 240mg，d1，q3w+Pemetrexed 500mg/m2，d1，q3w was taken until the disease progressed.<br>|
| Experimental: EGFR mutation<br> | Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin<br>* Surufatinib at the dose determined in phase safety lead-in，250 mg，qd，po，every 3 weeks(q3w) ; Toripalimab at the dose 240mg，iv, d1, given every 3 weeks (q3w); Pemetrexed at the dose 500 mg/m2，iv，d1，given every 3 weeks (q3w); Carboplatin at the dose AUC=5 6，iv，d1，given every 3 weeks (q3w) or Cisplatin at the dose 75 mg/m2，iv ,d1，q3w; Maintenance treatment：After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D，d1-21，q3w＋Toripalimab 240mg，d1，q3w+Pemetrexed 500mg/m2，d1，q3w was taken until the disease progressed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) |  | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate(ORR) |  | up to 24 months | 
| Disease control rate(DCR) |  | up to 24 months | 
| Overall Survival(OS) |  | up to 24 months |