The real-world effectiveness and safety of anlotinib (AL3818) treatment for advanced non-small cell lung cancer

ISRCTN ISRCTN35543977
DOI https://doi.org/10.1186/ISRCTN35543977
Secondary identifying numbers ChiCTR2000032265
Submission date
19/01/2021
Registration date
26/01/2021
Last edited
09/08/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Non-small cell lung cancer (NSCLC) accounts for 83% of all lung cancer. Anlotinib is now the standard drug treatment for patients with advanced NSCLC where chemotherapy has failed. However, not all patients with advanced NSCLC can tolerate or are willing to receive chemotherapy in the first place. Similarly, the effectiveness of chemotherapy alone is limited. This study aims to collect patient data to evaluate the potential effectiveness and safety of anlotinib either alone or combined with additional drugs for treating NSCLC. The goal is to provide an option for patients with advanced NSCLC who are not suitable for chemotherapy and provide evidence of the combination of anlotinib with other treatments. The study's findings should help to improve the treatment of patients with advanced lung cancer.

Who can participate?
Adults over the age of 18 who are diagnosed with advanced NSCLC and receive anlotinib treatment

What does the study involve?
The investigators will review the electronic records of Peking University Shenzhen Hospital and screen the participants' data. Participants will be retrospectively allocated to one of two cohorts: those who received anlotinib treatment in the first place and those who received the treatment after other treatments failed. The study lasts 6 months in total.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part, but there should be benefits to the future treatment of advanced NSCLC because the results of the study are likely to influence how the physicians decide the treatment strategy. The main risk is that participants' information could get released into public view. To protect patient information, the researchers will minimize patient identifiers by assigning each participant with a unique code. All data generated in the study will be stored in the hospital with the unique code; the list of the unique codes will be maintained on secure servers, accessible to key research personnel only.

Where is the study run from?
Peking University Shenzhen Hospital (China)

When is the study starting and how long is it expected to run for?
January 2020 to September 2020

Who is funding the study?
1. Special Funding for Clinical Scientific Research of Wu Jieping Medical Foundation (China)
2. Shenzhen Sanming Project (China)
3. Shenzhen Science and Technology Innovation Commission Project (China)

Who is the main contact?
Dr Fen Wang
fina_wang@163.com

Contact information

Dr Fen Wang
Scientific

No. 1120 Lianhua Road
Futian District
Shenzhen
518036
China

ORCiD logoORCID ID 0000-0002-4876-710X
Phone +86 (0)13610331485
Email fina_wang@163.com

Study information

Study designObservational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleThe efficacy and safety of anlotinib (AL3818) treatment in patients with advanced non-small cell lung cancer in the real world
Study objectivesAL3818 (anlotinib) is a multi-targeted tyrosine kinase inhibitor mainly blocking vascular endothelial growth factor signaling pathway and has been approved by the National Medical Products Administration of China for ≥3rd line treatment of advanced NSCLC. Despite the lack of evidence of frontline treatment, AL3818 may be preferred in clinical practice for patients with advanced NSCLC who are unsuitable or unwilling to receive standard care. The synergism between anti-angiogenesis and chemotherapy, targeted therapy, and immunotherapy validated by more and more preclinical and clinical evidence additionally provides the rationale for a combined strategy with these regimens. Furthermore, oral AL3818 therapy during the COVID-19 pandemic has irreplaceable advantages. Therefore, the researchers propose a scientific hypothesis that the front-line or combined use of AL3818 is effective in the treatment of advanced NSCLC.
Ethics approval(s)Approved 04/29/2020, China Ethics Committee of Registering Clinical Trials (Chinese Clinical Trial Registry Hong Kong Center, Hong Kong Baptist University Road, Hong Kong SAR, China; +86 (0)18980604562; chictr@vip.qq.com), ref: ChiCTR2000032265
Health condition(s) or problem(s) studiedAdvanced non-small cell lung cancer
InterventionPatients with stage IIIB to IV or recurrent NSCLC who received AL3818 or AL3818-containing regimens between 01/06/2018 to 30/09/2020 are enrolled in the study. AL3818 is administered orally once daily on day 1 to day 14 of a 21-day cycle and is continued until tumor progression, death, or unacceptable toxicity. Tumor responses are assessed by both radiologists and oncologists every 6 to 12 weeks or significant progression occurred or necessary.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)AL3818
Primary outcome measureProgression-free survival (PFS), defined as the time from the first administration to the documented disease progression or death due to any cause, data collected from the electronic medical system of Peking University Shenzhen Hospital, assessed every 6 to 12 weeks
Secondary outcome measuresData collected from the electronic medical system of Peking University Shenzhen Hospital, assessed every 6 to 12 weeks:
1. Objective response rate (ORR), defined as the percentage of patients with at least one confirmed response before any evidence of progression
2. Disease control rate (DCR), defined as the percentage of patients with at least one confirmed response plus stable disease before any evidence of progression
3. Overall survival (OS), defined as the time from the first administration to death from any cause or last follow-up
4. Toxicity, as categorized and graded according to the NCI-CTCAE
Overall study start date01/01/2020
Completion date30/09/2020

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200
Total final enrolment203
Key inclusion criteria1. Age ≥8 years
2. Pathologically confirmed stage IIIB/IV or recurrent NSCLC
3. Had at least one radiologically measurable disease as assessed using Response Evaluation Criteria in Solid Tumours (RECIST, version 1.1); and they did not receive local treatment such as radiotherapy or interventional therapy for the target lesions during anlotinib treatment
Key exclusion criteria1. Other pathological types than NSCLC including small cell lung cancer (including mixed with small cell and non-small cell lung cancer)
2. Patients who are diagnosed with malignancies other than NSCLC within the previous 5 years (except those with negligible risk of metastases or death and treated with curative intent, based on primary investigator discretion)
Date of first enrolment20/04/2020
Date of final enrolment30/09/2020

Locations

Countries of recruitment

  • China

Study participating centre

Peking University Shenzhen Hospital
No.1120 Lianhua Road
Futian District
Shenzhen
518036
China

Sponsor information

Peking University Shenzhen Hospital
Hospital/treatment centre

No. 1120 Lianhua Road
Futian District
Shenzhen
518036
China

Phone +86 (0)13510331485
Email pkuszh_oncology@163.com
Website https://www.pkuszh.com
ROR logo "ROR" https://ror.org/03kkjyb15

Funders

Funder type

Research organisation

Special Funding for Clinical Scientific Research of Wu Jieping Medical Foundation (320.6750.19088-10)

No information available

Shenzhen Sanming Project (SZSM201612041)

No information available

Science, Technology and Innovation Commission of Shenzhen Municipality (GJHZ20180420180754917 and ZDSYS20190902092855097)
Government organisation / Local government
Alternative name(s)
Shenzhen Science and Technology Innovation Commission, Shenzhen Science and Technology Innovation Committee, 深圳市科技创新委员会
Location
China

Results and Publications

Intention to publish date01/03/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Fen Wang (fina_wang@163.com).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 04/02/2021 No No
Results article 06/08/2021 09/08/2021 Yes No

Additional files

ISRCTN35543977_PROTOCOL.docx
uploaded 04/02/2021

Editorial Notes

09/08/2021: Publication reference added.
04/02/2021: Uploaded protocol (not peer reviewed) Version n/a, no date.
25/01/2021: Trial's existence confirmed by China Ethics Committee of Registering Clinical Trials.