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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT05271916 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require EGFR?
Yes, EGFR L858R mutation in exon 21 is a required biomarker for enrollment.
Are patients with EGFR alterations eligible?
No. EGFR T790M mutation is an exclusion criterion.
What disease stage is eligible?
Stage IIIB or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages