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

NCT02976116 | Completed Phase 2

• 1 other identifier: 2016-013-00CH1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Conditions

NSCLC

Keywords

Fruquintinib; NSCLC; 1st line

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Progression-free survival (PFS)

  Patients will be followed until study completion, an average of 1 year

• Duration control rate (DCR)

  Patients will be followed until study completion, an average of 1 year

• Time to response (TTR)

  Patients will be followed until study completion, an average of 1 year

• Duration of response （DoR）

  Patients will be followed until study completion, an average of 1 year

Study Arms (1)

Fruquintinib & Gefitinib

EXPERIMENTAL

Drug: Fruquintinib and Gefitinib

Drug: Fruquintinib; Drug: Gefitinib

Interventions

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

Also known as: HMP-013

Fruquintinib & Gefitinib

Gefitinib DRUG

Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity

Also known as: Iressa

Fruquintinib & Gefitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

The First Hospital of Zhejiang University

Hangzhou, China

Location

MeSH Terms

Interventions

HMPL-013; Gefitinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hongyan Yin

  Hutchison MediPharma Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 29, 2016
• Study Start: December 1, 2016
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: November 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)