NCT05132985

Neoadjuvant Icotinib With Chemotherapy for Epidermal Growth Factor Receptor(EGFR)-Mutated Resectable Lung Adenocarcinoma

Neoadjuvant Icotinib With Chemotherapy for Resectable Stage II-IIIB N2 EGFR Mutation-positive Lung Adenocarcinoma: A Phase II Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Liaoning Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Icotinib is a first-generation inhibitor of EGFR-tyrosine kinase inhibitor in patients with non-small-cell lung cancer (NSCLC). Here we will evaluate neoadjuvant Icotinib with chemotherapy prior to surgery, in patients with resectable stage II-IIIB N2 EGFR mutation-positive NSCLC. The primary endpoint is centrally assessed major pathological response at the time of resection. Secondary endpoints include pathological complete response, objective response rate, R0 resection rate at the time of resection, disease-free survival, and overall survival. Safety and tolerability will also be assessed.

Conditions

• NSCLC
• EGF-R Positive Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Icotinib	125mg 1tt(Take 1 tablet 3 times a day) orally.
DRUG	Cisplatin	75 mg/m2 (IV，Q3W)
DRUG	Carboplatin	AUC 5 (IV, Q3W)
DRUG	Pemetrexed	500 mg/m2 (IV, Q3W)

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-07-01
• Completion: 2028-01-01
• First posted: 2021-11-24
• Last updated: 2021-12-10

Locations

1 site across 1 country: China