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

Sun Yat-sen University

Status and phase: Withdrawn; Phase 2

Conditions: Lung Cancer

Treatments: Procedure: Gefitinib-surgery-gefitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02347839

wsy005 (Other Identifier)

GASTO1004

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Intervention group

Experimental group

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.

Treatment:

Procedure: Gefitinib-surgery-gefitinib