OncoMatch/Clinical Trials/NCT05104788
A Study of Icotinib With Chemotherapy as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
Is NCT05104788 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Icotinib and Cisplatin for non-small cell lung cancer.
Treatment: Icotinib · Cisplatin · Carboplatin · Pemetrexed — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR ex19del, L858R
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 sensitivity (Ex19del, L858R).
Disease stage
Required: Stage IIA, IIB, IIIA, IIIB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic anti-cancer therapy
Lab requirements
Blood counts
a leukocyte count less than 4000 mm3, a platelet count less than 100,000 mm3, and a hemoglobin level less than 10 g/dL [excluded]
Kidney function
not normal serum creatinine and blood urea nitrogen levels, and a creatinine clearance level 60 mg/minute [excluded]
Liver function
serum aspartate aminotransferase level more than 2.5 times the upper normal limit (UNL) and a serum alanine aminotransferase level more than 2.5 times the UNL [excluded]
Cardiac function
Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis). Clinically significant cardiovascular disease, that is, active or within 3 months prior to enrollment: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (NYHA Class ≥ II), second-degree or third-degree AV block (unless paced) or any AV block with PR >220 msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥ 2, uncontrolled atrial fibrillation of any grade, bradycardia defined as <50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read ECG with QTc >470 msec, or congenital long QT syndrome [excluded]
Hematology, liver and kidney function are adequate for neoadjuvant therapy. Cardiopulmonary function suitable for surgical treatment (ECG, echocardiography, pulmonary function or blood gas analysis). Inadequate bone marrow reserve (a leukocyte count less than 4000 mm3, a platelet count less than 100,000 mm3, and a hemoglobin level less than 10 g/dL); adequate renal function deficiency (not normal serum creatinine and blood urea nitrogen levels, and a creatinine clearance level 60 mg/minute); and an inadequate serum aspartate aminotransferase level more than 2.5 times the upper normal limit (UNL) and a serum alanine aminotransferase level more than 2.5 times the UNL. Clinically significant cardiovascular disease, that is, active or within 3 months prior to enrollment: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure (NYHA Class ≥ II), second-degree or third-degree AV block (unless paced) or any AV block with PR >220 msec; or ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥ 2, uncontrolled atrial fibrillation of any grade, bradycardia defined as <50 bpm (unless patient is otherwise healthy such as long-distance runners, etc.), machine-read ECG with QTc >470 msec, or congenital long QT syndrome.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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