Status:
UNKNOWN
Icotinib With Concurrent Radiotherapy Versus Chemotherapy With Concurrent Radiotherapy in Non-small Cell Lung Cancer
Lead Sponsor:
Betta Pharmaceuticals Co., Ltd.
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus chemotherapy with concurrent radiotherapy in non-small cel...
Detailed Description
This randomised, multi-center, controlled trial is designed to assess the efficacy and safety of icotinib with concurrent radiotherapy versus etoposide/cisplatin with concurrent radiotherapy in stage ...
Eligibility Criteria
Inclusion
- Unresectable stage IIIA / IIIB non-small cell lung cancer with EGFR 19/21 mutation
- No previous systemic anticancer therapy
- Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site
- ECOG Performance Status of 0 to 1
Exclusion
- Prior treatment with anti-EGFR (the epidermal growth factor receptor) monoclonal antibody or small molecular compounds therapy such as gefitinib, erlotinib or cetuximab
- Evidence of clinically active Interstitial Lung Diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
- Known severe hypersensitivity to icotinib or any of the excipients of this product
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02215356
Start Date
August 1 2014
End Date
February 1 2019
Last Update
August 13 2014
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China, 100021
2
People's Liberation Army 307 Hospital
Beijing, Beijing Municipality, China, 100039
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
4
Beijing Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730