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

Non-small Cell Lung Cancer Clinical Trial

— 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02448797
• Other study ID #: BD-IC-IV-61
• Secondary ID: CCTC-1501
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 8, 2015
• Est. completion date: December 2023

Study information

• Verified date: October 2020
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 320
• Est. completion date: December 2023
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• Icotinib
125 mg three times daily (375 mg per day) orally for two years.
• 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.

Locations

Country	Name	City	State
China	307 Hospital of PLA	Beijing	Beijing
China	Fujian Provincal Cancer Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong
China	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou	Zhejiang
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival	the time from the date of randomization to the first observation of tumor recurrence, metastasis (based on imaging ) or death	48 months
Secondary	overall survival	The time from the date of randomization to death from any cause	60 months