Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients

NSCLC Clinical Trial

— Convince  

Official title:

Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719536
• Other study ID #: BD-IC-IV36
• Status: Completed
• Phase: Phase 3
• Start date: December 2012
• Est. completion date: February 7, 2017

Study information

• Verified date: July 2019
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.

Description:

This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 296
• Est. completion date: February 7, 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.

• Positive EGFR Mutation.

• No previous systemic anticancer therapy.

• Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.

• Provision of written informed consent.

Exclusion Criteria:

• Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.

• Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).

• Known severe hypersensitivity to icotinib or any of the excipients of this product.

• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• NSCLC

Intervention

Drug:
• Icotinib
Icotinib: 125 mg is administered orally three times per day.
• Chemotherapy
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.

Locations

Country	Name	City	State
China	Beijing Hospital for Chest Tumors & Tuberculosis Diseases	Beijing	Beijing
China	Chinese People's Liberation Army (PLA) General Hospital	Beijing	Beijing
China	The First Bethune Hospital of Jilin Univercity	Changchun	Jilin
China	Sichuan Provincal Tumor Hospital	Chengdu	Sichuan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Xinqiao Hospital, The Third Military Medical University	Chongqing	Chongqing
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong
China	Harbin Medical Univercity Cancer Hospital	Harbin	Heilongjiang
China	The First Affiliated Hospital of Anhui Medical Univercity	Hefei	Anhui
China	Shandong Cancer Hospital	Jinan	Shandong
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu Provincal Tumor Hospital	Nanjing	Jiangsu
China	Changhai Hospital, The Second Military Medical University	Shanghai	Shanghai
China	Shanghai Chest Hospital Affiliated to Shanghai Jiaotong Univercity	Shanghai	Shanghai
China	Zhongshan Hospital Affiliated to Fudan Univercity	Shanghai	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Hebei Provincal Tumor Hospital	Shijiazhuang	Hebei
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Xijing Hospital	Xian	Shanxi
China	Henan Provincal Tumor Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

Shi YK, Wang L, Han BH, Li W, Yu P, Liu YP, Ding CM, Song X, Ma ZY, Ren XL, Feng JF, Zhang HL, Chen GY, Han XH, Wu N, Yao C, Song Y, Zhang SC, Song W, Liu XQ, Zhao SJ, Lin YC, Ye XQ, Li K, Shu YQ, Ding LM, Tan FL, Sun Y. First-line icotinib versus cisplat — View Citation

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.	12 months
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.	20 months
Secondary	Objective response rate	Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.	12 weeks