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

Study Overview
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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

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.

Official Title
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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

Conditions
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NSCLC

Intervention / Treatment
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* Drug: Fruquintinib
* Drug: Gefitinib


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fruquintinib & Gefitinib<br>Drug: Fruquintinib and Gefitinib | Drug: Fruquintinib<br>* Fruquintinib will be administered orally once daily from Day 1 to Day 21 per 28-day cycle until disease progression or unacceptable toxicity<br>* Other names: HMP-013;Drug: Gefitinib<br>* Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity<br>* Other names: Iressa;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor objective response rate | 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 | 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) | 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) | 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) | 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） | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fruquintinib, NSCLC, 1st line