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

NCT02347839 | Withdrawn Phase 2 DMC

• 2 other identifiers: GASTO1004wsy005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Resectability rate

  3 months

Secondary Outcomes (3)

• Number of participants with perioperative complications

  1 year

• Event-free survival

  2 years after the last patient is randomized

• Overall survival

  2 years after the last patient is randomized

Study Arms (1)

Intervention group

EXPERIMENTAL

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.

Procedure: Gefitinib-surgery-gefitinib

Interventions

Gefitinib-surgery-gefitinib PROCEDURE

neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib

Also known as: neooadjuvant gefitinib followed by surgery and gefitinib

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Si-Yu Wang

  Guangdong Province Association Study of Thoracic Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)