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

NCT07130916 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-19

No results posted yet for this study

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

Interventions

DRUG

Aumolertinib

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.

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-05
Primary Completion
2025-08-09
Completion
2027-12-31

Countries

  • Bosnia and Herzegovina
  • Bulgaria
  • Moldova

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07130916 on ClinicalTrials.gov