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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02125240
Other study ID # BD-IC-IV-59
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date September 2014
Est. completion date July 2021

Study information

Verified date July 2018
Source Betta Pharmaceuticals Co.,Ltd.
Contact Yuan-Kai Shi, MD
Phone 010-87788293
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare 3years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.


Description:

This study is designed to compare 3 years of disease-free survival (DFS) of Icotinib and placebo in the treatment of patients who EGFR mutation-positive II-IIIA lung adenocarcinoma.

Primary Outcome Measure:

Disease-free survival between Icotinib group and placebo group.

Secondary Outcome Measures:

Overall survival between Icotinib group and placebo group. Lung cancer symptoms and health-related quality of life (HRQoL) . Number of participants with adverse events.


Recruitment information / eligibility

Status Recruiting
Enrollment 124
Est. completion date July 2021
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Pathologically confirmed lung adenocarcinoma after surgical resection

- Stage II-IIIA disease according to 7th edition of TNM staging

- Patients must harbor sensitive EGFR gene mutation (19/21)

- Received four cycles of platinum-based adjuvant chemotherapy.There are many different kinds of chemotherapy regimens including vinorelbine, gemcitabine, docetaxel, paclitaxel, pemetrexed plus cisplatin or carboplatin.The first cycle of chemotherapy with cisplatin dose of 75 mg / m2 ± 10% or carboplatin AUC = 5 ± 10% to calculate the dose of chemotherapy

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

- Presence of metastatic disease

- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ

- Any unresolved chronic toxicity from previous anticancer therapy

- Received antitumor radiation therapy (except for the stage IIIA N2 patients who received adjuvant radiotherapy after surgery)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Icotinib
125 mg three times daily (375 mg per day) by mouth
Placebo
1 tablet three times daily by mouth

Locations

Country Name City State
China 304 Hospital of PLA Beijing Beijing
China Beijing Chaoyang Hospital Beijing Beijing
China Beijing Hospital Beijing Beijing
China Beijing Union Medical College Hospital Beijing Beijing
China Cancer Hospital, Chinese Academy of Medical Science Beijing Beijing
China Capital Medical University, Beijing Chest Hospital Beijing Beijing
China China-japan friendship hospital in Beijing Beijing Beijing
China Peking University First Hospital Beijing Beijing
China Peking University People's Hospital Beijing Beijing
China People's Liberation Army General Hospital (301 Hospital) Beijing Beijing
China Xuanwu Hospital, Capital Medical University Beijing Beijing

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 DFS was defined as the time from the date of first dose of study medication to the date of death due to disease recurrence or disease progression. 36 months
Secondary Overall survival OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive. 60 months
Secondary Lung cancer symptoms and health-related quality of life (HRQoL) differences 60 months
Secondary Number of participants with adverse events 36 months
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