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

Hutchison Medipharma Limited50 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

NSCLC

Interventions

FruquintinibDRUG

Fruquintinib will be administered orally once daily from Day 1 to Day 21 per 28-day cycle until disease progression or unacceptable toxicity

GefitinibDRUG

Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

The First Hospital of Zhejiang University

Hangzhou, China

Outcomes

Primary Outcomes

tumor objective response rate

Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1

Time frame: Patients will be followed until study completion, an average of 1 year

Safety and tolerability

Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Time frame: Each patient will be followed for 30 days after the last dose

Secondary Outcomes

Progression-free survival (PFS)

The duration from first dose to first documented progression or death from any cause, whichever came first, assessed by RECIST 1.1

Time frame: Patients will be followed until study completion, an average of 1 year

Duration control rate (DCR)

Occurrence of completed response, or partial response, or stable disease, assessed by RECIST 1.1

Time frame: Patients will be followed until study completion, an average of 1 year

Time to response (TTR)

the period from the date of first dose to the date when the criteria for complete response or partial response was first measured

Time frame: Patients will be followed until study completion, an average of 1 year

Duration of response （DoR）

Duration from first documented completed response or partial response to first documented progression or death from any cause, whichever came first

Time frame: Patients will be followed until study completion, an average of 1 year

Data from ClinicalTrials.gov

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