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

Primary Purpose

NSCLC

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Icotinib
Chemotherapy
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NSCLC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Anhui Medical Univercity
  • Chinese People's Liberation Army (PLA) General Hospital
  • Beijing Hospital for Chest Tumors & Tuberculosis Diseases
  • Xinqiao Hospital, The Third Military Medical University
  • The First Affiliated Hospital Of Guangzhou Medical Collage
  • Nanfang Hospital, Southern Medical University
  • Hebei Provincal Tumor Hospital
  • Harbin Medical Univercity Cancer Hospital
  • Henan Provincal Tumor Hospital
  • Jiangsu Cancer Hospital
  • Jiangsu Provincal Tumor Hospital
  • The First Bethune Hospital of Jilin Univercity
  • The First Hospital of China Medical University
  • Shandong Cancer Hospital
  • Shanghai Chest Hospital Affiliated to Shanghai Jiaotong Univercity
  • Zhongshan Hospital Affiliated to Fudan Univercity
  • Changhai Hospital, The Second Military Medical University
  • Xijing Hospital
  • Sichuan Provincal Tumor Hospital
  • West China Hospital, Sichuan University
  • Tianjin Medical University Cancer Institute and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Icotinib

Chemotherapy

Arm Description

Icotinib 125mg is administered orally three times per day.

Patients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 29, 2012
Last Updated
July 2, 2019
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01719536
Brief Title
Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients
Acronym
Convince
Official Title
Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
February 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
296 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Icotinib
Arm Type
Experimental
Arm Description
Icotinib 125mg is administered orally three times per day.
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Patients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
BPI-2009, Conmana
Intervention Description
Icotinib: 125 mg is administered orally three times per day.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
ALIMTA
Intervention Description
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
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.
Time Frame
20 months
Title
Objective response rate
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Yuankai, M.D.
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Anhui Medical Univercity
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Chinese People's Liberation Army (PLA) General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
Beijing Hospital for Chest Tumors & Tuberculosis Diseases
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Facility Name
Xinqiao Hospital, The Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400037
Country
China
Facility Name
The First Affiliated Hospital Of Guangzhou Medical Collage
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Hebei Provincal Tumor Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Facility Name
Harbin Medical Univercity Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
110001
Country
China
Facility Name
Henan Provincal Tumor Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Facility Name
Jiangsu Provincal Tumor Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
The First Bethune Hospital of Jilin Univercity
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Shandong Cancer Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Facility Name
Shanghai Chest Hospital Affiliated to Shanghai Jiaotong Univercity
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Zhongshan Hospital Affiliated to Fudan Univercity
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Changhai Hospital, The Second Military Medical University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Xijing Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
Sichuan Provincal Tumor Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
28945850
Citation
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.
Results Reference
result

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

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