Clinical Trials /

A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer

NCT02976116

Description:

Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm, multicenter, phase II study

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer
  • Official Title: Fruquintinib in Combination With Gefitinib as First-line Therapy in Patients With Advanced Non-squamous Non-small-cell Lung Cancer Harboring Activating EGFR Mutations : a Single-arm, Multicenter, Phase II Study

Clinical Trial IDs

  • ORG STUDY ID: 2016-013-00CH1
  • NCT ID: NCT02976116

Conditions

  • NSCLC

Interventions

DrugSynonymsArms
FruquintinibHMP-013Fruquintinib & Gefitinib
GefitinibIressaFruquintinib & Gefitinib

Purpose

Fruquintinib in combination with Gefitinib as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring activating EGFR mutations : a single-arm, multicenter, phase II study

Detailed Description

      This phase II trial will evaluate the combination of fruquintinib and gefitinib in advanced
      NSCLC. The endpoint will be to evaluate the efficacy and safety of the combination.
    

Trial Arms

NameTypeDescriptionInterventions
Fruquintinib & GefitinibExperimentalDrug: Fruquintinib and Gefitinib
  • Fruquintinib
  • Gefitinib

Eligibility Criteria

        Inclusion Criteria:

          -  Signed Informed Consent Form.

          -  Age between 18 to 75 years old.

          -  Histologically or cytological documented stage IIIB/IV non-squamous non-small cell
             lung cancer patients who have never received systematic treatment for the late-stage
             disease.

          -  ECOG 0-1

          -  Patients must have measurable lesions

        Exclusion Criteria:

          -  Prior systematic treatment for the advanced NSCLC

          -  Absolute neutrophil count (ANC) < 1.5×10^9 /L, or platelet count < 100 ×10^9/L, or
             hemoglobin < 9 g/dL

          -  Total bilirubin > 1 ULN; SGOT (AST), SGPT (ALT), > 1.5 ULN; for patient with liver
             metastasis,AST or ALT > 3 ULN

          -  Known HIV positive

          -  Hypersensitivity to either of the investigation drugs
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:tumor response rate
Time Frame:Patients will be followed until study completion, an average of 1 year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival (PFS)
Time Frame:Patients will be followed until study completion, an average of 1 year
Safety Issue:
Description:
Measure:Disease control rate (DCR)
Time Frame:Patients will be followed until study completion, an average of 1 year
Safety Issue:
Description:
Measure:Duration of response (DoR)
Time Frame:Patients will be followed until study completion, an average of 1 year
Safety Issue:
Description:
Measure:Time to response (TTR)
Time Frame:Patients will be followed until study completion, an average of 1 year
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hutchison Medipharma Limited

Trial Keywords

  • Fruquintinib
  • NSCLC
  • 1st line

Last Updated

March 8, 2018