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Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation (EVIDENCE)

Primary Purpose

Non-small Cell Lung Cancer

Status
Active
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 Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically confirmed non-small cell lung cancer after surgical resection
  • Stage II-IIIA disease according to 7th edition of TNM staging
  • Positive EGFR gene mutation (19/21)
  • ECOG 0-1
  • At least 1-year life expectancy
  • Adequate organ function

Exclusion Criteria:

  • Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
  • Pneumonectomy of right lung
  • Any unresolved chronic toxicity from previous anticancer therapy
  • Allergic to study drug

Sites / Locations

  • 307 Hospital of PLA
  • Fujian Provincal Cancer Hospital
  • The First Affiliated Hospital Of Guangzhou Medical Collage
  • Shenzhen People's Hospital
  • The First Hospital of China Medical University
  • First Affiliated Hospital of China Medical University
  • Shanghai Pulmonary Hospital
  • The First Affiliated Hospital of Medical School of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

icotinib

standard chemotherapy

Arm Description

125 mg three times daily (375 mg per day) orally for two years.

Vinorelbine 25 mg/m^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles. cisplatin 75 mg/m^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m^2, day 1)/cisplatin (75 mg/m^2, day 1) for 4 cycles.

Outcomes

Primary Outcome Measures

disease free survival
the time from the date of randomization to the first observation of tumor recurrence, metastasis (based on imaging ) or death

Secondary Outcome Measures

overall survival
The time from the date of randomization to death from any cause

Full Information

First Posted
May 15, 2015
Last Updated
July 14, 2021
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02448797
Brief Title
Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation
Acronym
EVIDENCE
Official Title
Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA Non-small Cell Lung Cancer With EGFR-mutation: a Randomized, Positive-controlled, Phase 3 Study (EVIDENCE, CCTC-1501)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 8, 2015 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

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
Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage II-IIIA non-small cell lung cancer patients with EGFR mutation. The primary endpoint is disease-free survival.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
icotinib
Arm Type
Experimental
Arm Description
125 mg three times daily (375 mg per day) orally for two years.
Arm Title
standard chemotherapy
Arm Type
Active Comparator
Arm Description
Vinorelbine 25 mg/m^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles. cisplatin 75 mg/m^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m^2, day 1)/cisplatin (75 mg/m^2, day 1) for 4 cycles.
Intervention Type
Drug
Intervention Name(s)
Icotinib
Other Intervention Name(s)
Conmana
Intervention Description
125 mg three times daily (375 mg per day) orally for two years.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Navelbine, ALIMTA
Intervention Description
Vinorelbine 25 mg/m^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles, cisplatin 75 mg/m^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m^2, day 1)/cisplatin (75 mg/m^2, day 1) for 4 cycles.
Primary Outcome Measure Information:
Title
disease free survival
Description
the time from the date of randomization to the first observation of tumor recurrence, metastasis (based on imaging ) or death
Time Frame
48 months
Secondary Outcome Measure Information:
Title
overall survival
Description
The time from the date of randomization to death from any cause
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed non-small cell lung cancer after surgical resection Stage II-IIIA disease according to 7th edition of TNM staging Positive EGFR gene mutation (19/21) ECOG 0-1 At least 1-year life expectancy Adequate organ function Exclusion Criteria: Previous systemic anti-tumor therapy, including chemotherapy or targeted therapy(Including but not limited to monoclonal antibodies, small molecule tyrosine kinase inhibitor, etc Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ Pneumonectomy of right lung Any unresolved chronic toxicity from previous anticancer therapy Allergic to study drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, MD
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jianxing He, MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
307 Hospital of PLA
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Facility Name
Fujian Provincal Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
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
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
First Affiliated Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
150081
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
The First Affiliated Hospital of Medical School of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34280355
Citation
He J, Su C, Liang W, Xu S, Wu L, Fu X, Zhang X, Ge D, Chen Q, Mao W, Xu L, Chen C, Hu B, Shao G, Hu J, Zhao J, Liu X, Liu Z, Wang Z, Xiao Z, Gong T, Lin W, Li X, Ye F, Liu Y, Ma H, Huang Y, Zhou J, Wang Z, Fu J, Ding L, Mao L, Zhou C. Icotinib versus chemotherapy as adjuvant treatment for stage II-IIIA EGFR-mutant non-small-cell lung cancer (EVIDENCE): a randomised, open-label, phase 3 trial. Lancet Respir Med. 2021 Sep;9(9):1021-1029. doi: 10.1016/S2213-2600(21)00134-X. Epub 2021 Jul 21.
Results Reference
derived

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Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA NSCLC With EGFR-mutation

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