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

Sponsor

Betta Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02448797

Collaborator

(none)

320

Enrollment

Locations

Arms

101.8

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jun 8, 2015

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Dec 1, 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 Names: 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

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 Names:

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

disease free survival [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

overall survival [60 months]
The time from the date of randomization to death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	307 Hospital of PLA	Beijing	Beijing	China	100071
2	Fujian Provincal Cancer Hospital	Fuzhou	Fujian	China	350014
3	The First Affiliated Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong	China	510120
4	Shenzhen People's Hospital	Shenzhen	Guangdong	China	518020
5	The First Hospital of China Medical University	Shenyang	Liaoning	China	110001
6	First Affiliated Hospital of China Medical University	Shenyang	Liaoning	China	150081
7	Shanghai Pulmonary Hospital	Shanghai	Shanghai	China	200433
8	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Betta Pharmaceuticals Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02448797

Other Study ID Numbers:

BD-IC-IV-61
CCTC-1501

First Posted:

May 19, 2015

Last Update Posted:

Jul 20, 2021

Last Verified:

Oct 1, 2020

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Vinorelbine

Study Results

No Results Posted as of Jul 20, 2021