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

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

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.

Study Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Drug: Icotinib; Drug: Chemotherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical Univercity
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese People's Liberation Army (PLA) General Hospital
    • Beijing, Beijing, China, 101149
      • Beijing Hospital for Chest Tumors & Tuberculosis Diseases
  • Chongqing
    • Chongqing, Chongqing, China, 400037
      • Xinqiao Hospital, The Third Military Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China, 510120
      • The First Affiliated Hospital Of Guangzhou Medical Collage
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Hebei Provincal Tumor Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 110001
      • Harbin Medical Univercity Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincal Tumor Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Jiangsu Cancer Hospital
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Provincal Tumor Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Bethune Hospital of Jilin Univercity
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Chest Hospital Affiliated to Shanghai Jiaotong Univercity
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Affiliated to Fudan Univercity
    • Shanghai, Shanghai, China, 200433
      • ChangHai Hospital, The Second Military Medical University
  • Shanxi
    • Xian, Shanxi, China, 710032
      • Xijing Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
    • Chengdu, Sichuan, China, 610041
      • Sichuan Provincal Tumor Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icotinib; Icotinib 125mg is administered orally three times per day.	Drug: Icotinib; Icotinib: 125 mg is administered orally three times per day.; Other Names: BPI-2009; Conmana
Active Comparator: Chemotherapy; Patients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed.	Drug: Chemotherapy; First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.; Other Names: ALIMTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Shi Yuankai, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

General Publications

• 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 cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study. Ann Oncol. 2017 Oct 1;28(10):2443-2450. doi: 10.1093/annonc/mdx359.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): February 7, 2017

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung
• Other Study ID Numbers: BD-IC-IV36