OncoMatch/Clinical Trials/NCT05271916
First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations
Is NCT05271916 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Dacomitinib+Anlotinib and Dacomitinib for non-small cell lung cancer (nsclc).
Treatment: Dacomitinib+Anlotinib · Dacomitinib — This is a multicenter, open label, Phase I/IIB study investigating the efficacy and safety of treatment with dacomitinib plus anlotinib as first-line therapy for patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) 21-L858R mutations. This study comprises two parts: 1. A dose escalation Phase I study to determine the recommended phase II dose. 2. a multi-center, open label, randomized controlled, Phase IIB study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR L858R mutation in exon 21
Only subjects with the L858R mutation in exon 21 to be included in this Phase IIb
Excluded: EGFR T790M mutation
Patients with concurrent EGFR T790M mutation or unknown mutation status or other mutation types [excluded]
Disease stage
Required: Stage IIIB, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L, ANC ≥ 1.5x10^9/L, platelets ≥ 80x10^9/L
Kidney function
Creatinine ≤ 1.5 x ULN, or ≥ 60 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN, AST ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases), ALT ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases)
Cardiac function
LVEF ≥ 50% assessed by Doppler ultrasound
Adequate organ function, including: (1) Adequate bone marrow function Hemoglobin≥90g/L, absolute neutrophil count (ANC) should be ≥ 1.5x109/L, platelets should be ≥ 80x109/L; (2) Adequate liver function Total bilirubin ≤ 1.5 x upper normal limit (ULN), Aspartate Aminotransferase (AST) (SGOT) ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases), Alanine Aminotransferase (ALT) (SGPT) ≤ 2.5 x ULN (≤ 5.0 x ULN if hepatic metastases), Creatinine≤ 1.5 x upper normal limit (ULN), or ≥ 60 mL/min; (3) Cardiac function: LVEF≥50% assessed by Doppler ultrasound
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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