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

Sponsor

Hutchison Medipharma Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT02976116

Collaborator

(none)

Enrollment

Locations

Arm

30.9

Actual Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
NSCLC	Drug: Fruquintinib Drug: Gefitinib	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Jun 28, 2019

Actual Study Completion Date :

Jun 28, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

tumor objective response rate [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
Safety and tolerability [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

Secondary Outcome Measures

Progression-free survival (PFS) [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
Duration control rate (DCR) [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
Time to response (TTR) [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
Duration of response （DoR） [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Chest Hospital	Shanghai	Shanghai	China
2	The First Hospital of Zhejiang University	Hangzhou		China

Sponsors and Collaborators

Hutchison Medipharma Limited

Investigators

Study Director: Hongyan Yin, Hutchison MediPharma Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hutchison Medipharma Limited

ClinicalTrials.gov Identifier:

NCT02976116

Other Study ID Numbers:

2016-013-00CH1

First Posted:

Nov 29, 2016

Last Update Posted:

Nov 15, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Hutchison Medipharma Limited

Fruquintinib

NSCLC

1st line

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Gefitinib

Study Results

No Results Posted as of Nov 15, 2019