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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fruquintinib & Gefitinib | Experimental | Drug: Fruquintinib and Gefitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruquintinib | Drug | Fruquintinib will be administered orally once daily from Day 1 to Day 21 per 28-day cycle until disease progression or unacceptable toxicity |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongyan Yin | Hutchison MediPharma Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | China | |||
| The First Hospital of Zhejiang University |
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| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Gefitinib | Drug | Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity |
|
|
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 |
| Hangzhou |
| China |