NCT03656393

To Evaluate the Efficacy and Safety of Gefitinib in Adjuvant Chemotherapy for Lung Adenocarcinoma

Observational Clinical Trial of Adjuvant Chemotherapy for Non-squamous Cell Carcinoma of Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Shenzhen People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients.

Detailed description

The purpose of this study was to evaluate the efficacy and safety of targeted gefitinib versus oral vinorelbine and carboplatin in EGFR-mutant NSCLC patients. The purpose is to explore the role of TKI in neoadjuvant therapy, and to further improve disease-free survival (DFS) and pathologic complete remission (pCR) in EGFR-mutant populations; and reduce surgical complications and mortality. OBJECTIVES: To evaluate the efficacy of oral gefitinib versus neoadjuvant vinorelbine and carboplatin in operable stage II-IIIA EGFR-mutant non-squamous NSCLC patients, with a 2-year disease-free survival rate. 2yDFS). Secondary objective: To evaluate pCR, 0RR, and other efficacy measures (safety, complete) for oral gefitinib vs. neoadjuvant vinorelbine and carboplatin in patients with operable stage II-IIIA EGFR-mutant non-squamous cell carcinoma NSCLC. Resection rate, tumor regression, mediastinal lymph node clearance, perioperative complications, and mortality rate).

Conditions

• NSCLC
• EGFR

Interventions

Type	Name	Description
DRUG	Gefitinib	Gefitinib (250 mg, orally, every day) for 56 days
DRUG	Vinorelbine	Vinorelbine (60 mg/m2, orally, Once every three weeks) for 6 weeks
DRUG	Carboplatin	Carboplatin (AUC5, intravenously drip, once a week) for 6 weeks

Timeline

• Start date: 2018-08-31
• Primary completion: 2020-07-31
• Completion: 2020-09-30
• First posted: 2018-09-04
• Last updated: 2018-09-04

Locations

1 site across 1 country: China