Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma
1 other identifier
interventional
192
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2014
Longer than P75 for phase_4
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 31, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedApril 29, 2015
April 1, 2015
2 years
March 31, 2014
April 27, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Overall survival
24 months
Objective response rate
15 months
Adverse events
24 months
Study Arms (2)
Sequential icotinib plus chemotherapy
EXPERIMENTALSequential 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
ACTIVE COMPARATORIcotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
Interventions
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 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Lanzhou military region general hospital
Lanzhou, Gansu, 730050, China
General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010, China
Cancer Hospital of Sun Yat-sen
Guangzhou, Guangdong, 510060, China
First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, 510120, China
Jiangmen central hospital
Jiangmen, Guangdong, 529030, China
The university of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
Medical Oncology,Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
Thoracic Surgery,Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Guangdong Agribusiness Center Hospital
Zhanjiang, Guangdong, 524009, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Hainan Provincal Nong Ken Hospital
Haikou, Hainan, 570311, China
Hainan Provincial People's Hospital
Haikou, Hainan, 570311, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Medical Oncology，General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Radiation Oncology，General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Respiratory medicine，General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Baoji Central Hospital
Baoji, Shanxi, 721008, China
3201 Hospital, Hanzhong, Shanxi
Hanzhong, Shanxi, 723000, China
Shaanxi province people's hospital
Xi’an, Shanxi, 710000, China
Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
Xi'an Chang'an Hospital
Xi’an, Shanxi, 710018, China
Tangdu Hospital，Fourth Military Medical University
Xi’an, Shanxi, 710038, China
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Shanxi Cancer Hospital
Xi’an, Shanxi, 710061, China
Urumqi General Hospital of Lanzhou Military Region General Hospital
Ürümqi, Xinjiang, 830000, China
Xinjiang medical university affiliated tumor hospital
Ürümqi, Xinjiang, 830000, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Autonome Region Xinjiang Uygur Chinese medicine hospital
Ürümqi, Xinjiang, 830099, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helong Zhang, MD
Tang-Du Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2014
First Posted
April 3, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2016
Study Completion
September 1, 2017
Last Updated
April 29, 2015
Record last verified: 2015-04