Description:
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
Title
- Brief Title: A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer
- 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
Clinical Trial IDs
- ORG STUDY ID:
2016-013-00CH1
- NCT ID:
NCT02976116
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| Fruquintinib | HMP-013 | Fruquintinib & Gefitinib |
| Gefitinib | Iressa | Fruquintinib & Gefitinib |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Fruquintinib & Gefitinib | Experimental | Drug: Fruquintinib and Gefitinib | |
Eligibility Criteria
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | tumor objective response rate |
| Time Frame: | Patients will be followed until study completion, an average of 1 year |
| Safety Issue: | |
| Description: | Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1 |
Secondary Outcome Measures
| Measure: | Progression-free survival (PFS) |
| Time Frame: | Patients will be followed until study completion, an average of 1 year |
| Safety Issue: | |
| Description: | The duration from first dose to first documented progression or death from any cause, whichever came first, assessed by RECIST 1.1 |
| Measure: | Duration control rate (DCR) |
| Time Frame: | Patients will be followed until study completion, an average of 1 year |
| Safety Issue: | |
| Description: | Occurrence of completed response, or partial response, or stable disease, assessed by RECIST 1.1 |
| Measure: | Time to response (TTR) |
| Time Frame: | Patients will be followed until study completion, an average of 1 year |
| Safety Issue: | |
| Description: | the period from the date of first dose to the date when the criteria for complete response or partial response was first measured |
| Measure: | Duration of response （DoR） |
| Time Frame: | Patients will be followed until study completion, an average of 1 year |
| Safety Issue: | |
| Description: | Duration from first documented completed response or partial response to first documented progression or death from any cause, whichever came first |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | Hutchison Medipharma Limited |
Trial Keywords
- Fruquintinib
- NSCLC
- 1st line
Last Updated
November 15, 2019
