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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02103257
Other study ID # BD-IC-IV62
Secondary ID
Status Recruiting
Phase Phase 4
First received March 31, 2014
Last updated April 27, 2015
Start date March 2014
Est. completion date September 2017

Study information

Verified date April 2015
Source Betta Pharmaceuticals Co.,Ltd.
Contact Helong Zhang, MD
Phone 13709202616
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage IIIB/IV lung adenocarcinoma patients with EGFR mutation.


Recruitment information / eligibility

Status Recruiting
Enrollment 192
Est. completion date September 2017
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT)

- Patients must have previously untreated locally advanced or metastatic NSCLC

- EGFR activating mutation (exon 19 deletion, L858R) is required

- Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

Exclusion Criteria:

- Prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target EGFR

- Patients with wild-type EGFR

- Any other investigational agents are not permitted

- Any evidence of interstitial lung disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Sequential Icotinib Plus Chemotherapy
Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
Icotinib
Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.

Locations

Country Name City State
China Baoji Central Hospital Baoji Shanxi
China Cancer Hospital of Sun Yat-sen Guangzhou Guangdong
China First Affiliated Hospital of Guangzhou Medical College Guangzhou Guangdong
China General Hospital of Guangzhou Military Command Guangzhou Guangdong
China Hainan Provincal Nong Ken Hospital Haikou Hainan
China Hainan Provincial People's Hospital Haikou Hainan
China 3201 Hospital, Hanzhong, Shanxi Hanzhong Shanxi
China Jiangmen central hospital Jiangmen Guangdong
China First Hospital of Lanzhou University Lanzhou Gansu
China Lanzhou military region general hospital Lanzhou Gansu
China First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
China Medical Oncology,Shenzhen Second People's Hospital Shenzhen Guangdong
China Peking University Shenzhen Hospital Shenzhen Guangdong
China Shenzhen People's Hospital Shenzhen Guangdong
China The university of Hong Kong-Shenzhen Hospital Shenzhen Guangdong
China Thoracic Surgery,Shenzhen Second People's Hospital Shenzhen Guangdong
China Autonome Region Xinjiang Uygur Chinese medicine hospital Urumqi Xinjiang
China First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang
China Urumqi General Hospital of Lanzhou Military Region General Hospital Urumqi Xinjiang
China Xinjiang medical university affiliated tumor hospital Urumqi Xinjiang
China First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China Shaanxi province people's hospital Xi'an Shanxi
China Shanxi Cancer Hospital Xi'an Shanxi
China Tangdu Hospital,Fourth Military Medical University Xi'an Shanxi
China Xi'an Chang'an Hospital Xi'an Shanxi
China Medical Oncology,General Hospital of Ningxia Medical University Yinchuan Ningxia
China Radiation Oncology,General Hospital of Ningxia Medical University Yinchuan Ningxia
China Respiratory medicine,General Hospital of Ningxia Medical University Yinchuan Ningxia
China Guangdong Agribusiness Center Hospital Zhanjiang Guangdong
China First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression Free Survival A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed. 15 months No
Secondary Overall survival Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive. 24 months No
Secondary Objective response rate Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 15 months No
Secondary Adverse events The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0. 24 months Yes
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