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

NCT01843647 | Unknown Phase 2 DMC

• 1 other identifier: BD-IC-IV06
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Objective response rate

  8 weeks

• Disease free survival

  1 year

Secondary Outcomes (3)

• 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

Study Arms (2)

Icotinib

EXPERIMENTAL

Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.

Drug: Icotinib

Chemotherapy

ACTIVE COMPARATOR

Patients receive 8-week icotinib induction treatment before surgery and 4-cycle adjuvant chemotherapy with vinorelbine/cisplatin regimen after surgery.

Drug: Chemotherapy

Interventions

Icotinib DRUG

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.

Also known as: Commana, BPI-2009

Icotinib

Chemotherapy DRUG

After surgery patients receive 4-cycle adjuvant chemotherapy with vinorelbine /cisplatin regimen, until untolerable toxicity or disease progression.

Also known as: Vinorelbine, Cisplatin

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

icotinib; Drug Therapy; Vinorelbine; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Weimin Mao, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: April 30, 2013
• Study Start: April 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2018
• Last Updated: July 15, 2015

Record last verified: 2014-12

Locations

CN (1)