Clinical trial NCT04871997: A Real-world Study: Efficacy and Safety of Anlotinib for Advanced Non-small Cell Lung Cancer(NSCLC)
Official title: A Real-world Study: Efficacy and Safety of Anlotinib for Advanced Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSCLC
Keywords: NSCLC
anlotinib
PFS
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed as advanced non-small cell lung cancer and treated with anlotinib were included，with no gender restriction

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.

Eligibility criteria: 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.

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: 2019.7-2022.7
Secondary outcomes:
measure: overall survival (OS)
timeFrame: 2019.7-2022.7
measure: objective response rate (ORR)
timeFrame: 2019.7-2022.7
measure: disease control rate (DCR)
timeFrame: 2019.7-2022.7
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei province
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Qian Chu
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangyang Central Hospital
name: Tienan Yi
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangyang No.1 People's Hospital
name: Youhong Dong
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture
name: Ruizhi Ran
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangyang Hospital of Traditional Chinese Medicine
name: Yang Fu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of Xiao Gan
name: Guangqiao Qu
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of Xiao Gan
name: Jun Li
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of Xiao Gan
name: Yinping Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Jingzhou Central Hospital
name: Yanhua Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Yichang Central People's Hospital
name: Xinhua Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Taihe Hospital of Hubei University of Medicine
name: Zhiguo Luo
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiyan Renmin Hospital
name: Fengjun Cao
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongfeng Hospital Affiliated to Hubei Medical College
name: Li Kuang
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second People's Hospital of Yichang
name: Yifa Yin
role: PRINCIPAL_INVESTIGATOR
affiliation: JingMen NO.2 People's Hospital
name: Guiming Chen
role: PRINCIPAL_INVESTIGATOR
References: