Neoadjuvant Therapy of Icotinib in Epidermal Growth Factor Receptor Mutated NSCLC Patients

Non-small-cell Lung Cancer Clinical Trial

Official title:

Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01843647
• Other study ID #: BD-IC-IV06
• Status: Recruiting
• Phase: Phase 2
• First received: April 26, 2013
• Last updated: July 14, 2015
• Start date: April 2013
• Est. completion date: February 2018

Study information

• Verified date: December 2014
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the overall response rate and disease free survival for IIIAN2 non-small-cell lung cancer patients with EGFR 19 or 21 exon mutation.

Description:

Neoadjuvant therapy has been used for years to treat patients with non-small-cell lung cancer whose primary tumors are too large to allow for surgery. Reduction in size of the primary tumor with neoadjuvant therapy has made it possible for those patients. Moreover, the goals have expanded to include: determination of the sensitivity of the tumor so that subsequent therapy can be modified accordingly; to prolong disease free survival; to prolong survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 1.The patients signed the written informed consent. 2.The patients present with operable IIIAN2 non-small-cell lung cancers with 19 or 21 exon mutation.

3.The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy, and surgical therapy.

4.The patients' Eastern Cooperative Oncology Group scores are = 0-1. 5.The age of patient is = 18 years old with a life expectancy longer than 3 months.

Exclusion Criteria:

• 1. Patients with unresected tumor. 2. Wild EGFR type. 3. Allergic to the study drug.

4. Patients have severe non-cancerous diseases. 5. Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Icotinib
Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.Icotinib is administered orally with a dose 125 mg 3 times daily.
• Chemotherapy
After surgery patients receive 4-cycle adjuvant chemotherapy with vinorelbine /cisplatin regimen, until untolerable toxicity or disease progression.

Locations

Country	Name	City	State
China	Zhejiang cancer hospital	Hangzhou	Zhejiang

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	Objective response rate		8 weeks	No
Primary	Disease free survival		1 year	No
Secondary	The pathological complete response rate after neoadjuvant therapy with icotinib		8 weeks	No
Secondary	The lymph node staging reduction rate of patients after neoadjuvant therapy with icotinib		8 weeks	No
Secondary	The resection rate of patients after neoadjuvant therapy with icotinib		2 months	No