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Recruiting Phase 2 NCT05104788

A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

Trial Parameters

Condition Non-Small Cell Lung Cancer
Sponsor Peking University Cancer Hospital & Institute
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 27
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2021-10-25
Completion 2024-03-01
Interventions
IcotinibCisplatinCarboplatin

Brief Summary

This is a Phase II, single-Arm, prospective study of neoadjuvant Icotinib with chemotherapy for the treatment of patients with epidermal growth factor receptor mutation positive, resectable for stage II to IIIB(N2) Non-small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria: * Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. * Male or female, at least 18 years of age. * Histologically or cytologically documented lung adenocarcinoma within 60 days prior to study enrollment. * Clinical stage IIA/IIB/IIIA/IIIB assessed by EBUS-TBNA or PET(positron emission tomography)/CT can be resected. * EGFR mutation was detected by Amplification Refractory Mutation System(ARMS) and confirmed to be one of the 2 common EGFR mutations known to be associated with EGFR-TKI (epidermal growth factor receptor tyrosine kinase inhibitors)sensitivity (Ex19del, L858R). * Presence of at least one accurately measurable lesion, CT showing a maximum diameter of 10mm at baseline (except for lymph nodes with a short axis of 15mm required) and suitable for accurate repeat measurements. * Eastern Cooperative Oncology Group (ECOG)

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