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In vitro antitumor activity and clinical efficacy of almonertinib in NSCLC with uncommon EGFR mutation

In vitro antitumor activity and clinical efficacy of almonertinib in NSCLC with uncommon EGFR mutation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049155
Enrollment
Unknown
Registered
2021-07-24
Start date
2021-08-16
Completion date
Unknown
Last updated
2022-04-04

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

In vitro study:None
In vivo study:None

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. In vitro experiments (1) Aged 18 to 75 years; (2) NSCLC diagnosed by histopathology and expressing any rare EGFR mutation such as 20 insertion, G719X, L861Q, S768I or L747S; (3) Malignant pleural effusion exists, and pleural effusion treatment is required; (4) The subjects themselves participated voluntarily and signed the informed consent in writing. 2. In vivo experiments (1) Aged 18 to 75 years; (2) NSCLC was diagnosed by histopathology, and there were rare mutations in EGFR exons 18-21 detected by second-generation high-throughput sequencing; (3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, and no deterioration in the previous 2 weeks, with a minimum expected survival of 12 weeks; (4) The patient has at least one tumor lesion that can be accurately measured at baseline, and the longest diameter at baseline is >=10 mm (if it is a lymph node, the short diameter is required to be >=15 mm). The measurement method chosen is suitable for accurate repeat measurements and can be computed tomography (CT) or magnetic resonance scan (MRI). If there is only one measurable lesion, it can be accepted as a target lesion, and a baseline evaluation of tumor lesions should be performed at least 14 days after diagnostic biopsy; (5) are receiving or planning to receive almetinib treatment; (6) The subjects themselves participated voluntarily and signed the informed consent in writing.

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to Ametinib mesylate tablets and/or its excipients; 2. Pregnant or lactating women; 3. There are contraindications to Ametinib; 4. The doctor thinks it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
ty of almonertinib to inhibit the growth of Plasmacytoid Dendritic Cells;Mechanism of almonertinib;

Secondary

MeasureTime frame
Changes of tumor volume;Progression free survival;Overall survival;Safety;

Countries

China

Contacts

Public ContactZhang Yu

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

whxhzy@163.com+86 27 65650894

Outcome results

None listed

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