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NCT Number: NCT04871997

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hubei province

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: ≥18 years old, no gender limit.
  • Diagnosed as advanced non-small cell lung cancer.
  • 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.
  • Doctors evaluate the benefits of receiving Anlotinib treatment.
  • 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

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

Treatment and study plan

Primary outcomes

  1. progression-free survival (PFS)

    Time frame: 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 outcomes

  1. overall survival (OS)

    Time frame: 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.

  2. objective response rate (ORR)

    Time frame: 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

  3. disease control rate (DCR)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Qian Chu

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 4, 2021
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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