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

November 14, 2019 updated by: Hutchison Medipharma Limited

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China
        • The First Hospital of Zhejiang University
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Chest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fruquintinib & Gefitinib
Drug: Fruquintinib and Gefitinib
Drug: Fruquintinib
Fruquintinib will be administered orally once daily from Day 1 to Day 21 per 28-day cycle until disease progression or unacceptable toxicity
Other Names:
  • HMP-013
Drug: Gefitinib
Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity
Other Names:
  • Iressa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tumor objective response rate
Time Frame: Patients will be followed until study completion, an average of 1 year
Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1
Patients will be followed until study completion, an average of 1 year
Safety and tolerability
Time Frame: Each patient will be followed for 30 days after the last dose
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Each patient will be followed for 30 days after the last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: Patients will be followed until study completion, an average of 1 year
The duration from first dose to first documented progression or death from any cause, whichever came first, assessed by RECIST 1.1
Patients will be followed until study completion, an average of 1 year
Duration control rate (DCR)
Time Frame: Patients will be followed until study completion, an average of 1 year
Occurrence of completed response, or partial response, or stable disease, assessed by RECIST 1.1
Patients will be followed until study completion, an average of 1 year
Time to response (TTR)
Time Frame: Patients will be followed until study completion, an average of 1 year
the period from the date of first dose to the date when the criteria for complete response or partial response was first measured
Patients will be followed until study completion, an average of 1 year
Duration of response （DoR）
Time Frame: Patients will be followed until study completion, an average of 1 year
Duration from first documented completed response or partial response to first documented progression or death from any cause, whichever came first
Patients will be followed until study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hutchison Medipharma Limited

Investigators

  • Study Director: Hongyan Yin, Hutchison MediPharma Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2016

Primary Completion (ACTUAL)

June 28, 2019

Study Completion (ACTUAL)

June 28, 2019

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 24, 2016

First Posted (ESTIMATE)

November 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-013-00CH1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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