NCT05498064

A Real World Study of Ensartinib in Advanced ALK-positive NSCLC

A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 490 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.

Detailed description

Participants will receive Ensartinib at 225 mg orally once a day (QD). Treatments will continue until disease progression, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy). At the time of disease progression, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier. Collection of venous blood sample from participants included 3 times: before treatment, 8 weeks of treatment, and disease progression. Blood specimens of 8 ml were collected each time for ctDNA NGS testing, and evaluation of Ensartinib population pharmacokinetics with blood sampling after 8 weeks.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Anaplastic Lymphoma Kinase I1171N
• Ensartinib

Interventions

Type	Name	Description
DRUG	Ensartinib	Ensartinib 225 mg administered once daily orally

Timeline

• Start date: 2022-05-13
• Primary completion: 2025-12-31
• Completion: 2028-12-01
• First posted: 2022-08-11
• Last updated: 2022-08-11

Locations

1 site across 1 country: China