Icotinib as Adjuvant Therapy in Treating Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

Non-small-cell Lung Cancer Clinical Trial

Official title:

Randomized, Open-label, Multicenter Study of Icotinib as Adjuvant Therapy in Treating Stage II-IIIA Non-small-cell Lung Cancer Patients With Positive EGFR Mutation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01929200
• Other study ID #: BD-IC-IV50
• Status: Recruiting
• Phase: Phase 2
• First received: August 21, 2013
• Last updated: May 21, 2015
• Start date: August 2013
• Est. completion date: August 2017

Study information

• Verified date: May 2015
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: Yue Yang, MD
• Phone: 86-10-88196568
• Email: zlyangyue[@]bjmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating such patients. The primary endpoint is to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib.

Description:

Adjuvant therapy has been proved effective in treating stage II-IIIA non-small-cell lung cancer. However, few data on the treating time of adjuvant therapy is available. Here we conduct a randomized, prospective study to compare the recurrence-free survival after 1-year or 2-year treatment with icotinib in EGFR-mutated non-small cell lung cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The patients signed the written informed consent

• The patients present with operable stage II-IIIA non-small-cell lung cancers with 19 or 21 exon mutation

• The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy

• The patients' Eastern Cooperative Oncology Group scores are = 0-2

Exclusion Criteria:

• Patients with unresected tumor

• Wild EGFR type

• Allergic to the study drug

• Patients have severe non-cancerous diseases

• Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• 1-year treatment with icotinib
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.
• 2-year treatment with icotinib
Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.

Locations

Country	Name	City	State
China	Beijing Cancer hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

Lv C, Ma Y, Feng Q, Fang F, Bai H, Zhao B, Yan S, Wu N, Zheng Q, Li S, Chen J, Wang J, Feng Y, Wang Y, Pei Y, Fang J, Yang Y. A pilot study: sequential gemcitabine/cisplatin and icotinib as induction therapy for stage IIB to IIIA non-small-cell lung adenocarcinoma. World J Surg Oncol. 2013 Apr 26;11:96. doi: 10.1186/1477-7819-11-96. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free Survival		6 months	No
Secondary	Overall survival		6 months	No