OncoMatch/Clinical Trials/NCT07130916
A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer
Is NCT07130916 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Aumolertinib for non-small cell lung cancer.
Treatment: Aumolertinib — This is a Phase 1, open-label, multicenter, multiple-dose study to evaluate aumolertinib in European participants with a confirmed diagnosis of activating EGFR mutation positive (EGFRm+) locally advanced or metastatic NSCLC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
Required: EGFR l858r
Required: EGFR t790m
Disease stage
Required: Stage IIIB, IIIC, IVA, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: neoadjuvant or adjuvant therapy — nonmetastatic
Participants who have received prior neoadjuvant, adjuvant therapies with curative intent for nonmetastatic disease must have completed treatment for at least 12 months prior to the development of recurrent or metastatic disease
Must have received: first- or second-generation EGFR-TKI — locally advanced or metastatic
Participant who only received one line of first- or second-generation EGFR-TKI in the locally advanced or metastatic setting and have documented radiological progression prior to enrolling in the study
Cannot have received: third-generation EGFR-TKI (osimertinib)
Treatment with prior third-generation EGFR-TKI (e.g., osimertinib)
Cannot have received: first- or second-generation EGFR-TKI (erlotinib, gefitinib)
Exception: within 8 days of the first dose of study intervention or 5 half-lives, whichever is the longer
Treatment with a first- or second-generation EGFR-TKI (e.g., erlotinib or gefitinib) within 8 days of the first dose of study intervention or 5 half-lives, whichever is the longer
Cannot have received: cytotoxic chemotherapy
Exception: within 14 days of the first dose of study intervention or 5 half-lives, whichever is longer
Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study taken within 14 days of the first dose of study intervention or 5 half lives, whichever is longer
Cannot have received: investigational agent
Exception: within 28 days or 5 half-lives, whichever is longer, before Screening Visit
Participants participated in any interventional clinical study or had been treated with any investigational drugs within 28 days or 5 half-lives, whichever is longer, before Screening Visit
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5 × 10^9/L; Platelet count ≥ 80 × 10^9/L; Hemoglobin ≥ 90 g/L
Kidney function
Creatinine ≤ 1.5 × ULN concurrent with creatinine clearance ≥ 50 mL/min (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance only required when creatinine is ≤ 1.5 × ULN
Liver function
ALT ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases; AST ≤ 2.5 × ULN if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases; Total bilirubin (TBL) ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases
Cardiac function
mean resting corrected QTcF > 470 ms obtained from three ECGs; any clinically important abnormalities in rhythm, conduction or morphology of resting ECG; PR interval > 250 ms; LVEF ≤ 40%
Adequate bone marrow reserve or organ function without blood transfusion or growth factor support ≤ 14 days before sample collection at screening as demonstrated by laboratory values (see full criteria for details); cardiac criteria: mean resting corrected QTcF > 470 ms, ECG abnormalities, PR interval > 250 ms, LVEF ≤ 40%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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