NCT04646824

Almonertinib With Chemotherapy in mEGFR NSCLC

A Study of Almonertinib With Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The reason for the study is to find out if an experimental combination of an oral medication called Almonertinib when used in combination with chemotherapy is more effective for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR).

Detailed description

In total the study aims to enroll approximately 36 patients who will receive almonertinib in combination with chemotherapy in the main trial. The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre.

Conditions

• Non-Small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Almonertinib Pemetrexed/Cisplatin	Pemetrexed/Cisplatin Drug: Pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Almonertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.

Timeline

• Start date: 2020-11-19
• Primary completion: 2020-11-28
• Completion: 2022-11-25
• First posted: 2020-11-30
• Last updated: 2020-12-02

Locations

1 site across 1 country: China