NSCLCNCT04871997
A Real-world Study: Efficacy and Safety of Anlotinib for Advanced Non-small Cell Lung Cancer(NSCLC)
An observational study of NSCLC, run by Qian Chu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- How many people
- 373 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2019to 16 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed as advanced non-small cell lung cancer and treated with anlotinib were included，with no gender restriction
Who may be able to join
- 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.
Who cannot join
- Those who have been confirmed to be allergic to anlotinib and/or its excipients.
- Patients with anlotinib contraindications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-world Study: Efficacy and Safety of Anlotinib for Advanced Non-small Cell Lung Cancer
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.
Read the 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.
- Conditions
- NSCLC
- Keywords
- NSCLC, anlotinib, PFS
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
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
Measured: 2019.7-2022.7
Secondary outcomes (3)
overall survival (OS)
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.
Measured: 2019.7-2022.7
objective response rate (ORR)
the percentage of patients on whom a therapy has some defined effect; for example, the cancer shrinks or disappears after treatment
Measured: 2019.7-2022.7
disease control rate (DCR)
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.
Measured: 2019.7-2022.7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start12 Jul 2019
- Primary completion16 Jul 2022
- Study completion16 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qian Chu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qian Chu, Tongji Hospital
- Investigators
- Qian Chu, Principal investigator, Tongji HospitalTienan Yi, Principal investigator, Xiangyang Central HospitalYouhong Dong, Principal investigator, Xiangyang No.1 People's HospitalRuizhi Ran, Principal investigator, The Central Hospital of Enshi Tujia And Miao Autonomous PrefectureYang Fu, Principal investigator, Xiangyang Hospital of Traditional Chinese MedicineGuangqiao Qu, Principal investigator, The Central Hospital of Xiao GanJun Li, Principal investigator, The Central Hospital of Xiao GanYinping Li, Principal investigator, The Central Hospital of Xiao Gan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871997
- Sponsor's protocol ID
- S1040
- Status last verified
- Oct 2022
- First submitted
- 26 Apr 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang J, Dong Y, Cao F, Ran R, Yin Y, Li Y, Fu Y, Xu Y, Kuang L, Chen G, Qu G, Li J, Luo Z, Song Q, Chen Y, Xu X, Yi T, Chu Q. Prospective Multicenter Observational Study of Anlotinib in Advanced Non-Small Cell Lung Cancer: Real-World Evidence From China. Thorac Cancer. 2026 Jun;17(11):e70306. doi: 10.1111/1759-7714.70306.
PubMed 42246683
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study: Efficacy and Safety of Anlotinib for Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04871997
- Acronym / sponsor ID
- S1040
- Conditions
- NSCLC
- Keywords
- NSCLC, anlotinib, PFS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Qian ChuUniversity, hospital or other
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 16 Jul 2022 (actual)
- Study completion
- 16 Jul 2022 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed as advanced non-small cell lung cancer and treated with anlotinib were included，with no gender restriction
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Those who have been confirmed to be allergic to anlotinib and/or its excipients.
- Patients with anlotinib contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
overall survival (OS)
Time frame: 2019.7-2022.7
objective response rate (ORR)
Time frame: 2019.7-2022.7
disease control rate (DCR)
Time frame: 2019.7-2022.7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Derived from this study: PubMed 42246683Wang J, Dong Y, Cao F, Ran R, Yin Y, Li Y, Fu Y, Xu Y, Kuang L, Chen G, Qu G, Li J, Luo Z, Song Q, Chen Y, Xu X, Yi T, Chu Q. Prospective Multicenter Observational Study of Anlotinib in Advanced Non-Small Cell Lung Cancer: Real-World Evidence From China. Thorac Cancer. 2026 Jun;17(11):e70306. doi: 10.1111/1759-7714.70306.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qian Chu principal investigator
Tongji Hospital
Tienan Yi principal investigator
Xiangyang Central Hospital
Youhong Dong principal investigator
Xiangyang No.1 People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Qian Chu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: 2019.7-2022.7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04871997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.