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Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC

Primary Purpose

EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Icotinib combined dihydroaremisinin
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy
  2. Male or female patients aged ≥18 years, life expectancy ≥ 12 weeks
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  4. Sensitive EGFR gene mutation(19/21)
  5. Failed with first-line icotinib and have gradually progressed disease More than 6-month duration of first-line icotinib (from the first dosing to the imaging-confirmed progression; and discontinuation of icotinib is less than 14 days) No significantly increased tumor size compared with the final imaging evaluation

Exclusion Criteria:

  1. Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)
  2. Female subjects should not be pregnant or breast-feeding
  3. Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
  4. Previous systemic anti-tumor therapy except for icotinib , including chemotherapy or targeted therapy ( including but not limited to monoclonal or antibodies, small molecule tyrosine kinase inhibitor, etc)
  5. Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination

Sites / Locations

  • Beijing Cancer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Icotinib combined dihydroaremisinin

Arm Description

Outcomes

Primary Outcome Measures

Progress Free Survival
Objective response rate

Secondary Outcome Measures

Overall Survival

Full Information

First Posted
January 11, 2018
Last Updated
January 11, 2018
Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03402464
Brief Title
Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC
Official Title
Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced Gradually Progressed NSCLC After First-line Icotinib: an Open-label, Single-arm, Multicenter Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
June 1, 2019 (Anticipated)
Study Completion Date
September 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute
Collaborators
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study was to evaluate the safety, PFS and ORR of icotinib/dihydroaremisinin (DHA)-based combination therapy in EGFR-mutated, advanced NSCLC patients who have gradually progressed disease after first-line icotinib treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EGFR Positive Non-Small Cell Lung Cancer,Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Icotinib combined dihydroaremisinin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Icotinib combined dihydroaremisinin
Intervention Description
Icotinib should be taken by the patients continuously until disease progressed or intolerable toxicity. On day 1-3, oral dihydroaremisinin was given at 20mg per day, the dose of dihydroaremisinin is increased to 40mg daily on day 4 to 6, and 80mg twice daily until disease progressed or intolerable toxicity.
Primary Outcome Measure Information:
Title
Progress Free Survival
Time Frame
18 months
Title
Objective response rate
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients confirmed with stage IV lung adenocarcinoma by pathologic histology or cytology who can't accept surgery and radiotherapy Male or female patients aged ≥18 years, life expectancy ≥ 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Sensitive EGFR gene mutation(19/21) Failed with first-line icotinib and have gradually progressed disease More than 6-month duration of first-line icotinib (from the first dosing to the imaging-confirmed progression; and discontinuation of icotinib is less than 14 days) No significantly increased tumor size compared with the final imaging evaluation Exclusion Criteria: Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease) Female subjects should not be pregnant or breast-feeding Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol Previous systemic anti-tumor therapy except for icotinib , including chemotherapy or targeted therapy ( including but not limited to monoclonal or antibodies, small molecule tyrosine kinase inhibitor, etc) Tumor metastasis of the spinal cord, meninges or meningeal neoplasms confirmed by imaging or cerebrospinal fluid examination
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziping Wang, MD
Phone
86-10-88121122
Email
wangzp2007@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziping Wang, MD
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ziping Wang, MD
Phone
86-10-88121122
Email
wangzp2007@126.com
First Name & Middle Initial & Last Name & Degree
Ziping Wang, MD

12. IPD Sharing Statement

Learn more about this trial

Icotinib Combined With Dihydroaremisinin (DHA) Therapy in Patients With Advanced NSCLC

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