Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer

Icotinib as Neoadjuvant Therapy in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer: a Single Arm, Phase II Clinical Study

The main purpose of this study is to evaluate the efficacy and safety of Icotinib as neoadjuvant in EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery.

Study Overview

• Status: Recruiting
• Conditions: EGF-R Positive Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Icotinib

Detailed Description

Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy; then patients with clinical benefits receive surgical resection of the tumor. If there is curative effect of Icotinib according to the RECIST or pathological report, the patients will continue receive Icotinib for two years as adjuvant therapy after surgery or till progressive disease or unaccepted toxicity. The primary objective of this study is evaluate the efficacy and safety of Icotinib neoadjuvant therapy.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shugeng Gao, MD; Phone Number: 13801185056; Email: gaoshugeng@vip.sina.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Cancer Hospital, Chinese Academy of Medical Science
    • Contact: Shugeng Gao, MD
    • Principal Investigator: Shugeng Gao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histology or cytology confirmed Non-small Cell Lung Cancer; EGFR mutation (EGFR 19del and/or 21L858R) detected by tumor tissue biopsy of primary lesion or metastatic lesion or plasma ctDNA
• No previous anti-tumor treatment such as surgery, chemotherapy, radiotherapy or biological therapy
• Stage IIIA N2 NSCLC according to the pathological evidence of endobronchial ultrasound(EBUS) or PET-CT, the short-axis diameter of lymph node 1-2cm, and considered surgically resectable at baseline by the surgical oncologist
• Sufficient tumor histological specimens (non-cytology) for molecular marker analysis
• At least one lesion with measurable diameter and its longest diameter is large than 10 mm by CT measurement

Exclusion Criteria:

• Previous systemic anti-tumor treatment of Non-small Cell Lung Cancer, including cytotoxic drug therapy, targeted drug therapy (tyrosine kinase inhibitors or monoclonal antibodies) and experimental treatment, etc
• Previous local radiotherapy of Non-small Cell Lung Cancer
• Be allergic to any component of Icotinib tablet (Conmana)
• Other cancers within five years prior to the treatment of this study. Except for cervical carcinoma, basal cell carcinoma and bladder epithelial neoplasm (including Ta and Tis)
• Any instable systemic disease, including: active infection, high blood pressure out of control, unstable angina, onset of angina pectoris within the past 3 months, congestive heart failure, myocardial infarction, severe arrhythmia, liver, kidney or metabolic disease
• Previous interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy or any active intersexual lung disease with clinical evidence
• Idiopathic pulmonary fibrosis detected by CT scan at baseline;
• Not fully controlled eye inflammation or infections, or any condition that may lead to the above eye diseases
• Human immunodeficiency virus infection
• Patients undergoing major surgery or severe trauma within 2 months prior to the first use of the experimental drug
• Patients with Small Cell Lung Cancer
• Pregnant or lactating women
• Neurological or psychiatric disorders history, including epilepsy or dementia
• Other situations not appropriate to enter the group considering by the investigators

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Icotinib; Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib as neoadjuvant therapy before surgery and adjuvant therapy or till progressive disease or unaccepted toxicity.	Drug: Icotinib; Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy before surgery and for 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity.; Other Names: Conmana

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	eight weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
R0 resection rate	eight weeks
Disease Control Rate	eight weeks
Decrease in cT-stage	eight weeks
pathologic complete remission rate	eight weeks
Time to Tumor Progression	five years after surgery
Overall survival	five years after surgery
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	five years after surgery

Collaborators and Investigators

• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Shugeng Gao, Cancer Hospital, Chinese Academy of Medical Science

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: BD-IC-IV82

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No