A Real-world Study: Efficacy and Safety of Anlotinib for Advanced Non-small Cell Lung Cancer(NSCLC)

Qian Chu

Status: Completed

Conditions: NSCLC

Study type: Observational

Funder types: Other

Identifiers

NCT04871997

S1040

Details and patient eligibility

About

A real-world study: Efficacy and safety of Anlotinib for advanced non-small cell lung cancer：This study aims to observe and explore the efficacy and safety of anlotinib in patients with advanced non-small cell lung cancer in the real world, and to summarize the treatment experience of a broad population.

Full description

A real-world study: Efficacy and safety of Anlotinib for advanced non-small cell lung cancer：This study aims to observe and explore the efficacy and safety of anlotinib in patients with advanced non-small cell lung cancer in the real world, and to summarize the treatment experience of a broad population.This study is a non-interventional, prospective, observational, real-world case study and all registered data are collected from real clinical practice cases. Adult patients diagnosed as advanced non-small cell lung cancer and treated with anlotinib were included. At least one tumor lesion has not been subjected to local treatment such as irradiation in the past, and can be accurately measured, the longest diameter is ≥10 mm.The primary endpoint was progression-free survival (PFS) and the secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety.If the last patient reaches the main evaluation index or has intolerable toxic reaction, the observation will be finished, and the first one will prevail.Through Electronic Data Capture System (EDC) system, electronic case report form (eCRF) is used to replace paper-based case report form to collect and manage clinical trial data.

Enrollment: 373 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age: ≥18 years old, no gender limit.
2. Diagnosed as advanced non-small cell lung cancer.
3. At least one tumor lesion has not been subjected to local treatment such as irradiation in the past, and can be accurately measured, the longest diameter is ≥10 mm.
4. Doctors evaluate the benefits of receiving Anlotinib treatment.
5. The patient voluntarily joins the project and signs the informed consent. If any of the above items is "No", the patient is not suitable for this study.

Exclusion criteria

1. Those who have been confirmed to be allergic to anlotinib and/or its excipients.
2. Patients with anlotinib contraindications.