A Study of Aumolertinib in European Participants With Non-Small Cell Lung Cancer

NCT07130916 | Recruiting Phase 1

• 1 other identifier: HS-10296-108
• Study Type: interventional
• Target: 20
• Locations: 3 countries
• Sites: 6

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Tmax of of single and multiple doses of aumolertinib, its metabolite HAS-719, and other related metabolites in European participants with locally advanced or metastatic, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

  Time to reach Cmax

  Cycle2 Day1（each cycle is 21 days）

• Cmax of of single and multiple doses of aumolertinib, its metabolite HAS-719, and other related metabolites in European participants with locally advanced or metastatic, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

  Maximum plasma concentration

  Cycle2 Day1（each cycle is 21 days）

• AUC0-24h of of single and multiple doses of aumolertinib, its metabolite HAS-719, and other related metabolites in European participants with locally advanced or metastatic, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer

  Area under the plasma concentration-time curve form 0-24h

  Cycle2 Day1（each cycle is 21 days）

• Cmin of of single and multiple doses of aumolertinib, its metabolite HAS-719, and other related metabolites in European participants with locally advanced or metastatic, epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

  Minmum plasma concentration

  Cycle2 Day1（each cycle is 21 days）

Secondary Outcomes (1)

• Adverse events (AEs) of aumolertinib administered in European participants with locally advanced or metastatic, EGFR-mutated NSCLC.

  Through study completion, an average of 18 months

Study Arms (1)

HS-10296(Aumolertinib)

EXPERIMENTAL

In Part A, participants will receive aumolertinib 110 mg (2 × 55 mg tablet) once daily, orally administrated under fasted condition (fasting from 2 hours before to 1 hour after dosing) in 21-day treatment cycles. In Part B (i.e., Day 3 of treatment Cycle 2, and beyond), participants may continue study intervention until PD, death, intolerable toxicity, Investigator's decision, lost of follow-up, receiving another anti-cancer therapy, or any other pre-defined discontinuation criteria.

Drug: Aumolertinib

Interventions

Aumolertinib DRUG

In Part A, participants will receive aumolertinib 110 mg (2 × 55 mg tablet) once daily, orally administrated under fasted condition (fasting from 2 hours before to 1 hour after dosing) in 21-day treatment cycles. In Part B, participants may continue study intervention (aumolertinib 110 mg once daily) until PD, death, intolerable toxicity, Investigator's decision, lost of follow-up, receiving another anti-cancer therapy, or any other pre-defined discontinuation criteria.

Also known as: HS-10296

HS-10296(Aumolertinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female European participants (inhabitant of a European country and of European descent) must be ≥ 18 years of age, at the time of signing the informed consent.
• Histological or cytological confirmation diagnosis of newly diagnosed locally advanced (clinical stage IIIB or IIIC) or metastatic (clinical stage IVA or IVB) NSCLC or recurrent NSCLC (per The Eighth Edition of The American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual in Lung Cancer), not amenable to curative surgery or definitive radiotherapy with or without chemotherapy.
• NOTE: if small cell elements are present, the participant is ineligible.
• Prior anti-tumor systemic therapy. Participant must fulfill one of below:
• Participants who have not received any prior anti-tumor systemic therapy, and the tumor must harbor at least one of the EGFR mutations (ex19del or L858R).
• 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, and the tumor must harbor at least one of the EGFR mutations (ex19del or L858R).
• 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, and the tumor must harbor EGFR T790M mutation.
• Confirmation that the tumor harbors at least one of the EGFR mutations (ex19del, L858R, or T790M) using a clinically validated assay in a licensed laboratory with applicable local accreditation based on tumor tissue and/or circulating tumor deoxyribonucleic acid (ctDNA) in blood.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1 and no deterioration in the previous two weeks with a minimum life expectancy of 12 weeks.
• Participants must have evaluable disease. At least one measurable (not previously irradiated) and/or non-measurable lesions per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Appendix 6) that can be accurately assessed at baseline and suitable for repeated assessments by computed tomography (CT) or magnetic resonance imaging (MRI) scans. If only one measurable lesion exists, it is acceptable to be used (as a target lesion \[TL\]) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.
• Adequate bone marrow reserve or organ function without blood transfusion or growth factor support ≤ 14 days before sample collection at screening as demonstrated by any of the following laboratory values:
• Absolute neutrophil count ≥ 1.5 × 109/L;
• Platelet count ≥ 80 × 109/L;
• Hemoglobin ≥ 90 g/L;
• ALT ≤ 2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤ 5 × ULN in the presence of liver metastases;

You may not qualify if:

• Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study intervention with the exception of alopecia and Grade 2 neurotoxicity related to prior platinum-therapy.
• History of another primary malignancy except for the malignancy treated with curative intent with no known active disease ≤ 5 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include, but are not limited to, adequately resected non melanoma skin cancer, and curatively treated in situ disease.
• Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least four weeks prior to start of study intervention.
• Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding within two weeks prior to the first dose of study intervention, active infection (e.g., active HBV infection, HCV infection), or HIV infection, which in the Investigator's opinion makes it undesirable for the participant to participate in the study or which would jeopardise compliance with the protocol.
• Any of the following cardiac criteria: mean resting corrected QT (QT; the time from the start of the Q wave to the end of the T wave in an ECG) interval corrected for heart rate using Fridericia's correction factor (QTcF) \> 470 ms obtained from three ECGs; any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 ms; any factors that increase the risk of corrected QT (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under age of 40 or any concomitant medication known to prolong the QT interval; Left ventricular ejection fraction (LVEF) ≤ 40%.
• Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
• Refractory nausea, vomiting, or chronic GI disorders; Participants unable to swallow oral medication or participants with GI disorders or significant GI resection likely to interfere with the absorption of study intervention.
• Participant has any disease or condition that, in the judgment of the physician, may increase the risk to the safety or interfering with study assessments.
• Participant with a known hypersensitivity to study intervention, structural analog, or any of the excipients of the products.
• Received any of the following treatments:
• 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.
• Treatment with prior third-generation EGFR-TKI (e.g., osimertinib).
• 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.
• Treatment with medications known to be potent strong inhibitors or inducers of CYP3A4 or narrow therapeutic index drugs for CYP3A4 sensitive substrates (see Appendix 7) within 7 days of the first dose of study intervention or 5 half-lives, whichever is the longer.
• Major surgery (excluding placement of vascular access) within four weeks of the first dose of study intervention.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

Study Sites (6)

Republika Srpska University Clinical Centre of the Republic of Srpska, Dvanaest beba bb

Banja Luka, 78000, Bosnia and Herzegovina

RECRUITING

University Clinical Hospital Mosta, Bijeli Brijeg bb

Mostar, 78000, Bosnia and Herzegovina

RECRUITING

Clinical Center University of Sarajevo, Bolnicka 25

Sarajevo, 71000, Bosnia and Herzegovina

RECRUITING

Cantonal Hospital Zenica, Crkvice 67

Zenica, 72000, Bosnia and Herzegovina

RECRUITING

MHAT "Sveta Sofia" Departmet of Medical Oncology Bulgaria Blvd

Sofia, Grad, 104 1404, Bulgaria

RECRUITING

Arensia Exploratory Medicine Moldova - IMSP Institutul Oncologic. Strada Nicolae Testemitanu Nr 30

Chisinau, MD-2025, Moldova

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 19, 2025
• Study Start: December 5, 2024
• Primary Completion: August 9, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

BU (1); MO (1); BO (4)