Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma
- Conditions
- EGFR Positive Non-small Cell Lung CancerAdenocarcinoma
- Interventions
- Drug: Sequential Icotinib Plus Chemotherapy
- Registration Number
- NCT02103257
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 192
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sequential icotinib plus chemotherapy 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 Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
- Primary Outcome Measures
Name Time Method Progression Free Survival 15 months 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.
- Secondary Outcome Measures
Name Time Method Adverse events 24 months The number of patients who suffered adverse events, which is graded by NCI CTCAE version 4.0.
Overall survival 24 months 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.
Objective response rate 15 months Number of subjects with confirmed objective response according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Trial Locations
- Locations (31)
Urumqi General Hospital of Lanzhou Military Region General Hospital
🇨🇳Urumqi, Xinjiang, China
Jiangmen central hospital
🇨🇳Jiangmen, Guangdong, China
Medical Oncology,Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
Thoracic Surgery,Shenzhen Second People's Hospital
🇨🇳Shenzhen, Guangdong, China
Hainan Provincial People's Hospital
🇨🇳Haikou, Hainan, China
Medical Oncology，General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Respiratory medicine，General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Tangdu Hospital，Fourth Military Medical University
🇨🇳Xi'an, Shanxi, China
First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Lanzhou military region general hospital
🇨🇳Lanzhou, Gansu, China
General Hospital of Guangzhou Military Command
🇨🇳Guangzhou, Guangdong, China
First Affiliated Hospital of Guangzhou Medical College
🇨🇳Guangzhou, Guangdong, China
Cancer Hospital of Sun Yat-sen
🇨🇳Guangzhou, Guangdong, China
The university of Hong Kong-Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Guangdong Agribusiness Center Hospital
🇨🇳Zhanjiang, Guangdong, China
First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Hainan Provincal Nong Ken Hospital
🇨🇳Haikou, Hainan, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Baoji Central Hospital
🇨🇳Baoji, Shanxi, China
3201 Hospital, Hanzhong, Shanxi
🇨🇳Hanzhong, Shanxi, China
Radiation Oncology，General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Shaanxi province people's hospital
🇨🇳Xi'an, Shanxi, China
Xi'an Chang'an Hospital
🇨🇳Xi'an, Shanxi, China
First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shanxi, China
Shanxi Cancer Hospital
🇨🇳Xi'an, Shanxi, China
Xinjiang medical university affiliated tumor hospital
🇨🇳Urumqi, Xinjiang, China
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
Autonome Region Xinjiang Uygur Chinese medicine hospital
🇨🇳Urumqi, Xinjiang, China