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

NSCLC Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02976116
• Other study ID #: 2016-013-00CH1
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: June 28, 2019

Study information

• Verified date: August 2019
• Source: Hutchison Medipharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

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

Locations

Country	Name	City	State
China	The First Hospital of Zhejiang University	Hangzhou
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Hutchison Medipharma Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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