NCT04956146

Fruquintinib Combined With Sintilimab and Chemotherapy in the Treatment of Non-Small Cell Lung Cancer

A Single Arm,Open-label, Study of Fruquintinib Combined With Sintilimab and Chemotherapy in Patients With Unresectable or Metastatic Advanced Wild-type Genotype Non-squamous Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A phase II study to assess the efficacy and safety of Fruquintinib Combined With Sintilimab and Chemotherapy as a first-line treatment in patients with unresectable or metastatic advanced Wild-type Genotype non-squamous Non-small Cell Lung Cancer.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Fruquintinib，Sintilimab，Pemetrexed，Carboplatin	Fruquintinib,fruquintinib at the dose determined in phase safety lead-in,5mg-intermittent (2 weeks on/ 1 week off) ，po，every 3 weeks(q3w) ; Sintilimab at the dose 200mg，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=4\~5，iv，d1；given every 3 weeks (q3w); Maintenance treatment：After 4\~6 cycles of carboplatin treatment, Sintilimab 200mg, iv, d1, q3w；Fruquintinib RP2D intermittent(2 weeks on/1 weeks off), po，q3w； pemetrexed 500mg/m2, d1,iv, q3w until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal

Timeline

• Start date: 2022-02-02
• Primary completion: 2023-09-30
• Completion: 2024-09-30
• First posted: 2021-07-09
• Last updated: 2022-03-02

Locations

1 site across 1 country: China