Clinical trial NCT02103257: Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma
Official title: Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma: a Randomized, Open-label, Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: EGFR Positive Non-small Cell Lung Cancer
Adenocarcinoma
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-03
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: 15 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Objective response rate
timeFrame: 15 months
measure: Adverse events
timeFrame: 24 months
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: First Hospital of Lanzhou University
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou military region general hospital
state: Gansu
city: Guangzhou
country: China
facility: General Hospital of Guangzhou Military Command
state: Guangdong
city: Guangzhou
country: China
facility: Cancer Hospital of Sun Yat-sen
state: Guangdong
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen central hospital
state: Guangdong
city: Shenzhen
country: China
facility: The university of Hong Kong-Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Medical Oncology,Shenzhen Second People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Thoracic Surgery,Shenzhen Second People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Zhanjiang
country: China
facility: Guangdong Agribusiness Center Hospital
state: Guangdong
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Haikou
country: China
facility: Hainan Provincal Nong Ken Hospital
state: Hainan
city: Haikou
country: China
facility: Hainan Provincial People's Hospital
state: Hainan
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Yinchuan
country: China
facility: Medical Oncology，General Hospital of Ningxia Medical University
state: Ningxia
city: Yinchuan
country: China
facility: Radiation Oncology，General Hospital of Ningxia Medical University
state: Ningxia
city: Yinchuan
country: China
facility: Respiratory medicine，General Hospital of Ningxia Medical University
state: Ningxia
city: Baoji
country: China
facility: Baoji Central Hospital
state: Shanxi
city: Hanzhong
country: China
facility: 3201 Hospital, Hanzhong, Shanxi
state: Shanxi
city: Xi'an
country: China
facility: Shaanxi province people's hospital
state: Shanxi
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Chang'an Hospital
state: Shanxi
city: Xi'an
country: China
facility: Tangdu Hospital，Fourth Military Medical University
state: Shanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Urumqi
country: China
facility: Urumqi General Hospital of Lanzhou Military Region General Hospital
state: Xinjiang
city: Urumqi
country: China
facility: Xinjiang medical university affiliated tumor hospital
state: Xinjiang
city: Urumqi
country: China
facility: First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Urumqi
country: China
facility: Autonome Region Xinjiang Uygur Chinese medicine hospital
state: Xinjiang
Study officials:
affiliation: Tang-Du Hospital
name: Helong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: