- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03346811
Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer (CHALLENGE)
November 15, 2017 updated by: Betta Pharmaceuticals Co., Ltd.
Efficiency of Icotinib in Plasma ctDNA EGFR Mutation-positive Patients Diagnosed With Lung Cancer:a Single Arm,Multi-center,Open-label Study
this single arm,open-label,multi-center study is aimed to evaluate the efficiency of icotinib in plasma ctDNA EGFR mutation-positive patients diagnosed with lung cancer
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jie Wang, MD
- Phone Number: 13910704669
- Email: zlhuxi@163.com
Study Contact Backup
- Name: Zhijie Wang, MD
- Phone Number: 13466323860
- Email: jie_969@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100021
- Recruiting
- National Cancer Center/Cancer Hospital
-
Contact:
- Jie Wang, MD
- Phone Number: 13910704669
- Email: zlhuxi@163.com
-
Contact:
- Zhijie Wang, MD
- Phone Number: 13466323860
- Email: jie_969@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of peripheral lung cancer, but the pathological diagnosis is not yet clear.
- Plasma EGFR mutations (EGFR 19del and/or 21L858R) positive (simultaneously detected by Super-ARMS, ddPCR and NGS,any positive).
- unavailable of radical surgery or radical radiotherapy.
- not previously received anticancer therapy like surgery, chemotherapy, radiation therapy, and biotherapy etc.
- Palliative radiotherapy for bone metastases is permitted, but there is no continuous toxicity associated with radiation therapy.
- Age 18-75 years old with performance status of 0 to 3.
- With a measurable disease(longest diameters >=10mm with Spiral computed tomography (CT)) according to RECIST Criteria.None of the lesions treated with radiotherapy could be used as target lesions.
- Adequate hematological, biochemical and organ functions.
Exclusion Criteria:
- Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.
- Evidence of interstitial lung diseases
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study
- Other situations researchers think not appropriate to enter the group
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental: icotinib
Patients diagnosed with lung cancer with plasma EGFR mutation-positive are arranged to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
|
Patients with plasma EGFR mutation-positive are arranged to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: 12 weeks
|
Objective Response Rate
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS
Time Frame: 12 months
|
Progression-free survival
|
12 months
|
DCR
Time Frame: 12 months
|
disease control rate
|
12 months
|
OS
Time Frame: 20 months
|
overall survival
|
20 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 18, 2017
Primary Completion (Anticipated)
May 10, 2019
Study Completion (Anticipated)
March 10, 2020
Study Registration Dates
First Submitted
November 15, 2017
First Submitted That Met QC Criteria
November 15, 2017
First Posted (Actual)
November 17, 2017
Study Record Updates
Last Update Posted (Actual)
November 17, 2017
Last Update Submitted That Met QC Criteria
November 15, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BD-IC-IV90
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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