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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.

Phase 1RecruitingJiangsu Hansoh Pharmaceutical Co., Ltd.NCT07130916Data as of May 2026

Treatment: AumolertinibThis 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.

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Extracted 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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