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High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Routine dose icotinib
Higher dose icotinib
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology);
  • Pretreated with at least 1 platinum-based chemotherapy;
  • No previous targeted treatment such as gefitinib, erlotinib;
  • With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria;
  • WHO performance status(PS)<= 2;
  • Adequate organ functions;
  • Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

  • Allergic to icotinib;
  • Patients with metastatic brain tumors with symptoms;
  • Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab;
  • Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Sites / Locations

  • Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Higher dose icotinib

Routine dose icotinib

Arm Description

Patients with stable disease after 8-week routine dose icotinib treatment, are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 375 mg three times per day, till progressive disease or unaccepted toxicity.

Patients with stable disease after 8-week routine dose icotinib treatment, are administered with icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity.

Outcomes

Primary Outcome Measures

Progression-free survival

Secondary Outcome Measures

Overall survival
Response rate assessed using the RECIST criteria
The number of patients who suffered adverse events
Adverse events are assessed by Common Terminology Criteria for Adverse Events v4.0

Full Information

First Posted
January 1, 2014
Last Updated
May 21, 2015
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02027090
Brief Title
High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease
Official Title
High Dose Versus Routine Dose Icotinib in Pretreated Non-small Cell Lung Cancer Patients With Stable Disease: a Phase II Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We hypothesize that higher dose icotinib is related with better efficacy. The primary objective is to compare the progression-free survival of higher dose and routine dose of icotinib in treating pretreated advanced non-small cell lung cancer patients with stable disease after 8-week routine dose icotinib treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Higher dose icotinib
Arm Type
Experimental
Arm Description
Patients with stable disease after 8-week routine dose icotinib treatment, are randomly assigned to higher dose icotinib group to receive icotinib with a dose of 375 mg three times per day, till progressive disease or unaccepted toxicity.
Arm Title
Routine dose icotinib
Arm Type
Active Comparator
Arm Description
Patients with stable disease after 8-week routine dose icotinib treatment, are administered with icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity.
Intervention Type
Drug
Intervention Name(s)
Routine dose icotinib
Other Intervention Name(s)
Commana
Intervention Description
Icotinib is administered 125 mg three times daily.
Intervention Type
Drug
Intervention Name(s)
Higher dose icotinib
Other Intervention Name(s)
Commana
Intervention Description
After 8-week induction of icotinib with a dose of 125 mg three times daily, icotinib is administered 375 mg three times per day.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
18 months
Title
Response rate assessed using the RECIST criteria
Time Frame
2 months
Title
The number of patients who suffered adverse events
Description
Adverse events are assessed by Common Terminology Criteria for Adverse Events v4.0
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed stage IIIB/IV lung cancer(exclude patients confirmed by sputum cytology); Pretreated with at least 1 platinum-based chemotherapy; No previous targeted treatment such as gefitinib, erlotinib; With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)and >=20mm with conventional CT) according to RECIST Criteria; WHO performance status(PS)<= 2; Adequate organ functions; Signed and dated informed consent before the start of specific protocol procedures. Exclusion Criteria: Allergic to icotinib; Patients with metastatic brain tumors with symptoms; Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab; Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shun Lu, MD
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China

12. IPD Sharing Statement

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High Dose Versus Routine Dose Icotinib in Advanced Non-small Cell Lung Cancer Patients With Stable Disease

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