A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Posit
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
| Condition(s) | Non-Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | 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, |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Peking University Cancer Hospital & Institute |
| Locations | Beijing, China |
| Start date | 2021-10-25 |
| NCT ID | NCT05104788 |
| Official listing | https://clinicaltrials.gov/study/NCT05104788 |