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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-06-28

Brief Summary

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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

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Detailed Description

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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.

Conditions

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NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fruquintinib & Gefitinib

Drug: Fruquintinib and Gefitinib

Group Type EXPERIMENTAL

Fruquintinib

Intervention Type DRUG

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

Gefitinib

Intervention Type DRUG

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

Interventions

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Fruquintinib

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

Intervention Type DRUG

Gefitinib

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

Intervention Type DRUG

Other Intervention Names

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HMP-013 Iressa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No