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

Completed

• Conditions: NSCLC

• Registration Number: NCT04871997
• Lead Sponsor: Qian Chu

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-07-12
• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-05-02
• Study First Posted: 2021-05-04
• Primary Completion: 2022-07-16
• Study Completion: 2022-07-16
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 373

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	2019.7-2022.7	the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	2019.7-2022.7	the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
objective response rate (ORR)	2019.7-2022.7	the percentage of patients on whom a therapy has some defined effect; for example, the cancer shrinks or disappears after treatment
disease control rate (DCR)	2019.7-2022.7	the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents.

Trial Locations

Locations (1)

Hubei province; 🇨🇳 Wuhan, Hubei, China