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

Phase 2

Completed

• Conditions: NSCLC
• Interventions: Drug: Fruquintinib; Drug: Gefitinib

• Registration Number: NCT02976116
• Lead Sponsor: Hutchison Medipharma Limited

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

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 Timeline

• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-24
• Study First Posted: 2016-11-29
• Study Start: 2016-12
• Primary Completion: 2019-06-28
• Study Completion: 2019-06-28
• Status Verified: 2019-08
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fruquintinib & Gefitinib	Gefitinib	Drug: Fruquintinib and Gefitinib
Fruquintinib & Gefitinib	Fruquintinib	Drug: Fruquintinib and Gefitinib

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
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 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
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

Trial Locations

Locations (2)

The First Hospital of Zhejiang University; 🇨🇳 Hangzhou, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China