OncoMatch/Clinical Trials/NCT04841811
MRD Guiding Treatment After Almonertinib Induction Therapy for EGFRm+ Stage III NSCLC in the MDT Diagnostic Model.
Is NCT04841811 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Almonertinib for lung cancer.
Treatment: Almonertinib — This is an open-label, multi-center, randomized, phase III study. It is aimed to firstly evaluate the effectiveness and safety of almonertinib induction therapy in EGFR-mutated patients with unresectable stage III non-small cell lung cancer, and to evaluate the effectiveness and safety of dynamic MRD guided maintenance therapy with almonertinib after induction therapy with almonertinib and local therapy (radical surgery or radiotherapy) evaluated by MDT diagnostic model. The study includes a screening period (not more than 28 days after the subject with signed informed consent before first medication), treatment period (including induction therapy with almonertinib\\ radical therapy under MDT model\\ consolidation therapy with almonertinib) and follow-up period.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR ex19del, L858R
EGFR sensitive mutations (ie, exon 19 deletion or L858R, alone or coexisting, Or with other EGFR mutations, but patients with EGFR20 exon insertion mutations cannot be included in the group)
Excluded: EGFR exon 20 insertion
patients with EGFR20 exon insertion mutations cannot be included in the group
Disease stage
Required: Stage III
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: lung surgery
Have received lung surgery in the past
Cannot have received: EGFR tyrosine kinase inhibitor
Have used any EGFR tyrosine kinase inhibitor in the past
Cannot have received: systemic chemotherapy
Previously received any systemic chemotherapy or immunotherapy for lung cancer
Cannot have received: immunotherapy
Previously received any systemic chemotherapy or immunotherapy for lung cancer
Cannot have received: radiation therapy
Receive any lung cancer radiotherapy in the past
Cannot have received: proprietary Chinese medicines with anti-tumor effects
Exception: used for no more than 7 days and stopped for 2 weeks or more before drug treatment in this study
Have used proprietary Chinese medicines with anti-tumor effects in the past. Those who have used proprietary Chinese medicines with anti-tumor effects but have been used for no more than 7 days and have been stopped for 2 weeks or more before the drug treatment in this study can be included in the group.
Lab requirements
Blood counts
Absolute neutrophil count < 1.5×10^9/L; Platelet count < 90×10^9/L; Hemoglobin < 90 g/L (<9 g/dL); Serum albumin < 28 g/L
Kidney function
Creatinine > 1.5x ULN or creatinine clearance rate < 45 mL/min (Cockcroft-Gault formula)
Liver function
Alanine aminotransferase > 3x ULN; Aspartate aminotransferase > 3x ULN; Total bilirubin > 1.5x ULN
Cardiac function
Left ventricular ejection fraction (LVEF) < 50%
Insufficient bone marrow reserve or organ function, reaching any of the following laboratory limits... Alanine aminotransferase > 3x ULN; Aspartate aminotransferase > 3x ULN; Total bilirubin > 1.5x ULN; Creatinine > 1.5x ULN or creatinine clearance rate < 45 mL/min; Absolute neutrophil count < 1.5×10^9/L; Platelet count < 90×10^9/L; Hemoglobin < 90 g/L (<9 g/dL); Serum albumin < 28 g/L; Left ventricular ejection fraction (LVEF) < 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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