Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Wild-type Genotype
|
Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin
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.
|
| Experimental: EGFR mutation
|
Drug: Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin
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.
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival (PFS) [up to 24 months]
Secondary Outcome Measures
- Objective response rate(ORR) [up to 24 months]
- Disease control rate(DCR) [up to 24 months]
- Overall Survival(OS) [up to 24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Voluntary provision of informed consent.
-
Males or females aged 18-75.
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Histological or cytologically confirmed NSCLC, metastatic or non-resectable (stage IIIB-Ⅳ).
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At least one lesion can be measured by imaging.
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
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Life expectancy ≥ 12 weeks.
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None previous chemotherapy or targeted therapy(Arm:wild-type genotype).
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Patients should be confirmed acquired EGFR T790M mutation and received adequate EGFR-TKI treatment(Arm:EGFR mutation).
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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.
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Diagnosed with other malignant diseases other than NSCLC within 5 years.
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Have participated in other interventional clinical research treatments now or within 4 weeks.
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Have previously received multi-targeted kinase inhibitors therapy.
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Have active autoimmune diseases requiring systemic treatment within 2 years.
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Received systemic glucocorticoid therapy or immunosuppressive therapy within 2 weeks.
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Clinically uncontrollable pleural effusion/abdominal effusion.
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Vaccinated vaccines or attenuated vaccines within 4 weeks before the group;
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Pregnant or breastfeeding females.
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Other serious hazards to the safety of patients.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center | Guangzhou | Guang Dong | China |
Sponsors and Collaborators
- Li Zhang, MD
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HMPL-012-SPRING-L102