Surufatinib Combined With Toripalimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer
NCT05003037 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106
Last updated 2022-11-04
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.
Conditions
- Carcinoma, Non-Small-Cell Lung
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.
Sponsors & Collaborators
-
Li Zhang, MD
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-08
- Primary Completion
- 2023-04-30
- Completion
- 2025-04-30
Countries
- China
Study Locations
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