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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2023

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Wild-type Genotype
  • Experimental: EGFR mutation

Clinical Trial Outcome Measures

Primary Measures

  • Progression Free Survival (PFS)
    • Time Frame: up to 24 months

Secondary Measures

  • Objective response rate(ORR)
    • Time Frame: up to 24 months
  • Disease control rate(DCR)
    • Time Frame: up to 24 months
  • Overall Survival(OS)
    • Time Frame: up to 24 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Li Zhang, MD
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Li Zhang, MD, Professor – Sun Yat-sen University
  • Overall Contact(s)
    • Wenfeng Fang, MD., +86-15322302066, fangwf@sysucc.org.cn

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