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

Phase 2

• Conditions: Non-small-cell Lung Cancer
• Interventions: Drug: Chemotherapy; Drug: Icotinib

• Registration Number: NCT01843647
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-04-30
• Status Verified: 2014-12
• Last Update Submitted: 2015-07-14
• Last Update Posted: 2015-07-15
• Primary Completion: 2016-12
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Chemotherapy	Patients receive 8-week icotinib induction treatment before surgery and 4-cycle adjuvant chemotherapy with vinorelbine/cisplatin regimen after surgery.
Icotinib	Icotinib	Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.

Primary Outcome Measures

Name	Time	Method
Objective response rate	8 weeks
Disease free survival	1 year

Secondary Outcome Measures

Name	Time	Method
The pathological complete response rate after neoadjuvant therapy with icotinib	8 weeks
The lymph node staging reduction rate of patients after neoadjuvant therapy with icotinib	8 weeks
The resection rate of patients after neoadjuvant therapy with icotinib	2 months

Trial Locations

Locations (1)

Zhejiang cancer hospital; 🇨🇳 Hangzhou, Zhejiang, China