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Exploration of the Exposure Level of Aumolertinib and Its Correlation with Clinical Efficacy in Patients with Lung Cancer

Exploration of the Exposure Level of Aumolertinib and Its Correlation with Clinical Efficacy in Patients with Lung Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114329
Enrollment
Unknown
Registered
2025-12-10
Start date
2025-12-12
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

Case series:None

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with newly diagnosed primary stage III-IV non-small cell lung cancer (NSCLC) who are receiving aumolertinib monotherapy; 2. EGFR mutation-positive; 3. Aged >= 18 years; 4. ECOG PS score: 0 to 2 points; 5. Estimated survival time = 12 weeks, and patients are amenable to follow-up; 6. No concurrent chemotherapy, immunotherapy, radiotherapy, radiofrequency ablation, or other targeted agents were administered prior to or during treatment; 7. Presence of measurable disease per RECIST v1.1 (at least one target lesion).

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Active bacterial, viral, or fungal diseases requiring treatment that are not controlled; 3. Concurrent other malignant tumors;

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS);

Secondary

MeasureTime frame
Adverse Event;

Countries

China

Contacts

Public ContactXuefang Cheng

Shanghai General Hospital

kscxf100@126.com+86 21 37797950

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026