NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations. (NEGOTIATE)
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gefitinib-surgery-gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
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
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
Gefitinib-surgery-gefitinib. Induction gefitinib therapy was given for 8 weeks. Patients' resectability was assessed after 8-week gefitinib. Adjuvant gefitinib was given within 3-6 weeks after surgery until progression or unacceptable toxic effects.
Outcomes
Primary Outcome Measures
Resectability rate
Secondary Outcome Measures
Number of participants with perioperative complications
Event-free survival
Event-free survival was assessed from randomization to disease recurrence/progression or death from any cause.
Overall survival
Overall survival was assessed from randomization to death from any cause.
Full Information
NCT ID
NCT02347839
First Posted
January 21, 2015
Last Updated
April 19, 2018
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT02347839
Brief Title
NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Gefitinib-surgery-gefitinib. Induction gefitinib therapy was given for 8 weeks. Patients' resectability was assessed after 8-week gefitinib. Adjuvant gefitinib was given within 3-6 weeks after surgery until progression or unacceptable toxic effects.
Intervention Type
Procedure
Intervention Name(s)
Gefitinib-surgery-gefitinib
Other Intervention Name(s)
neooadjuvant gefitinib followed by surgery and gefitinib
Intervention Description
neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib
Primary Outcome Measure Information:
Title
Resectability rate
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of participants with perioperative complications
Time Frame
1 year
Title
Event-free survival
Description
Event-free survival was assessed from randomization to disease recurrence/progression or death from any cause.
Time Frame
2 years after the last patient is randomized
Title
Overall survival
Description
Overall survival was assessed from randomization to death from any cause.
Time Frame
2 years after the last patient is randomized
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Si-Yu Wang, MD
Phone
+86 20 87343439
Email
wsysums@163.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Si-Yu Wang
Organizational Affiliation
Guangdong Province Association Study of Thoracic Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Si-Yu Wang, Doctor
Phone
+86 20 87343439
Email
wsysums@163.net
12. IPD Sharing Statement
Learn more about this trial
NEoadjuvant Gefitinib fOllowed by Surgery and gefiTinib In unresectAble sTage III NSCLC With EGFR Mutations.
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