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

NCT04956146 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-03-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2023-09-30
Completion
2024-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04956146 on ClinicalTrials.gov