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

• ClinicalTrials.gov Identifier: NCT02448797
• Recruitment Status: Unknown
• First Posted: May 19, 2015
• Last Update Posted: July 20, 2021
• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Information provided by (Responsible Party): Betta Pharmaceuticals Co., Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Non-small Cell Lung Cancer	Drug: Icotinib; Drug: Chemotherapy	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 320 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: June 8, 2015
• Estimated Primary Completion Date: June 30, 2022
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: icotinib; 125 mg three times daily (375 mg per day) orally for two years.	Drug: Icotinib; 125 mg three times daily (375 mg per day) orally for two years.; Other Name: Conmana
Active Comparator: standard chemotherapy; 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.	Drug: Chemotherapy; 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.; Other Names: Navelbine; ALIMTA

Outcome Measures

Primary Outcome Measures :

1. disease free survival [ Time Frame: 48 months ]
   the time from the date of randomization to the first observation of tumor recurrence, metastasis (based on imaging ) or death

Secondary Outcome Measures :

1. overall survival [ Time Frame: 60 months ]
   The time from the date of randomization to death from any cause

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China, Beijing

307 Hospital of PLA

Beijing, Beijing, China, 100071

China, Fujian

Fujian Provincal Cancer Hospital

Fuzhou, Fujian, China, 350014

China, Guangdong

The First Affiliated Hospital Of Guangzhou Medical Collage

Guangzhou, Guangdong, China, 510120

Shenzhen People's Hospital

Shenzhen, Guangdong, China, 518020

China, Liaoning

The First Hospital of China Medical University

Shenyang, Liaoning, China, 110001

First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China, 150081

China, Shanghai

Shanghai Pulmonary Hospital

Shanghai, Shanghai, China, 200433

China, Zhejiang

The First Affiliated Hospital of Medical School of Zhejiang University

Hangzhou, Zhejiang, China, 310000

Sponsors and Collaborators

Betta Pharmaceuticals Co., Ltd.

Investigators

• Study Chair: Caicun Zhou, MD; Shanghai Pulmonary Hospital, Shanghai, China
• Study Chair: Jianxing He, MD; The First Affiliated Hospital of Guangzhou Medical University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Betta Pharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02448797
• Other Study ID Numbers: BD-IC-IV-61; CCTC-1501 ( Other Identifier: China Clinical Trial Consortium )
• First Posted: May 19, 2015
• Last Update Posted: July 20, 2021
• Last Verified: October 2020

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Vinorelbine; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action