Sequential Icotinib Plus Chemotherapy Versus Icotinib Alone as First-line Treatment in Stage IIIB/IV Lung Adenocarcinoma

Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02103257
• Other study ID #: BD-IC-IV62
• 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

• Adenocarcinoma
• Carcinoma, Non-Small-Cell Lung
• EGFR Positive Non-small Cell Lung Cancer

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