NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.

Lung Cancer Clinical Trial

— NEGOTIATE  

Official title:

A Multicenter Phase II Trial of Neoadjuvant Gefitinib Followed by Surgery, Followed by Adjuvant Gefitinib in Patients With Unresectable Stage III Non-Small Cell Lung Cancer Harboring Activating Epidermal Growth Factor Receptor Mutations.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02347839
• Other study ID #: GASTO1004
• Secondary ID: wsy005
• Status: Recruiting
• Phase: Phase 2
• First received: January 21, 2015
• Last updated: April 19, 2018
• Start date: January 2016
• Est. completion date: January 2022

Study information

• Verified date: April 2018
• Source: Sun Yat-sen University
• Contact: Si-Yu Wang, MD
• Phone: +86 20 87343439
• Email: wsysums[@]163.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable stage III NSCLC harboring EGFR mutations.

Description:

Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer (NSCLC), although surgery offers the chance of cure. With combined-modality therapy with radiation therapy and chemotherapy, the prognosis of stage III NSCLC remains poor. Gefitinib has shown great efficacy in NSCLC patients with EGFR mutations. This study is to studying neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib to see how well it works in treating patients with unresectable EGFR mutant stage III NSCLC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: January 2022
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Target population is unresectable stage III (III A-bulky N2, III B) NSCLC with EGFR activating mutation in exon 19 or 21

• Written informed consent provided

• Aged 18-75 years

• Able to comply with the required protocol and follow-up procedures

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Had a life expectancy of 12 weeks or more

• Adequate hematological function, liver function and renal function

• Female participants should not be pregnant or breast-feeding

Exclusion Criteria:

• Known severe hypersensitivity to gefitinib or any of the excipients of this product

• Inability to comply with protocol or study procedures

• Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab)

• Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder

• Interstitial pneumonia

• Eye inflammation not fully controlled or conditions predisposing the subject to this

• Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease)

• Known human immunodeficiency virus (HIV) infection

• Pregnancy or breast-feeding women

• History of neurologic or psychiatric disorders

• Ingredients mixed with small cell lung cancer patients

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• Gefitinib-surgery-gefitinib
neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resectability rate		3 months
Secondary	Number of participants with perioperative complications		1 year
Secondary	Event-free survival	Event-free survival was assessed from randomization to disease recurrence/progression or death from any cause.	2 years after the last patient is randomized
Secondary	Overall survival	Overall survival was assessed from randomization to death from any cause.	2 years after the last patient is randomized