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

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ClinicalTrials.gov Identifier: NCT02976116
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Hutchison Medipharma Limited

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

Condition or disease Intervention/treatment Phase
NSCLC Drug: Fruquintinib Drug: Gefitinib Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: Fruquintinib & Gefitinib
Drug: Fruquintinib and Gefitinib
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
Other Name: HMP-013

Drug: Gefitinib
Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity
Other Name: Iressa




Primary Outcome Measures :
  1. tumor response rate [ Time Frame: Patients will be followed until study completion, an average of 1 year ]
  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: Each patient will be followed for 30 days after the last dose ]

Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Patients will be followed until study completion, an average of 1 year ]
  2. Disease control rate (DCR) [ Time Frame: Patients will be followed until study completion, an average of 1 year ]
  3. Duration of response (DoR) [ Time Frame: Patients will be followed until study completion, an average of 1 year ]
  4. Time to response (TTR) [ Time Frame: Patients will be followed until study completion, an average of 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02976116


Locations
China, Shanghai
Shanghai Chest Hospital
Shanghai, Shanghai, China
China
The First Hospital of Zhejiang University
Hangzhou, China
Sponsors and Collaborators
Hutchison Medipharma Limited
Investigators
Study Director: Yiping Chen Hutchison MediPharma Ltd

Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT02976116     History of Changes
Other Study ID Numbers: 2016-013-00CH1
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hutchison Medipharma Limited:
Fruquintinib
NSCLC
1st line

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action