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NCT Number: NCT02976116

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

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

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Chest Hospital, Shanghai, Shanghai Municipality, China

Loading trial locations.

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: HMP-013

Gefitinib

Drug

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

Other names: Iressa

Primary outcomes

  1. tumor objective response rate

    Time frame: 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

  2. Safety and tolerability

    Time frame: 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 outcomes

  1. Progression-free survival (PFS)

    Time frame: 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

  2. Duration control rate (DCR)

    Time frame: 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

  3. Time to response (TTR)

    Time frame: 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

  4. Duration of response （DoR）

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hutchison Medipharma Limited

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2016
Registry last updated
Nov 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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