NSCLC
Conditions
Keywords
Fruquintinib, NSCLC, 1st line
Brief summary
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.
Interventions
DRUGFruquintinib
Fruquintinib will be administered orally once daily from Day 1 to Day 21 per 28-day cycle until disease progression or unacceptable toxicity
DRUGGefitinib
Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity
Sponsors
Hutchison Medipharma Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tumor objective response rate | Patients will be followed until study completion, an average of 1 year | Occurrence of completed response or partial response after treatment, assessed by RECIST 1.1 |
| Safety and tolerability | Each patient will be followed for 30 days after the last dose | Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Patients will be followed until study completion, an average of 1 year | The duration from first dose to first documented progression or death from any cause, whichever came first, assessed by RECIST 1.1 |
| Duration control rate (DCR) | Patients will be followed until study completion, an average of 1 year | Occurrence of completed response, or partial response, or stable disease, assessed by RECIST 1.1 |
| Time to response (TTR) | Patients will be followed until study completion, an average of 1 year | the period from the date of first dose to the date when the criteria for complete response or partial response was first measured |
| Duration of response （DoR） | Patients will be followed until study completion, an average of 1 year | Duration from first documented completed response or partial response to first documented progression or death from any cause, whichever came first |
Countries
China
Outcome results
None listed