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

Not Applicable

Completed

• Conditions: Advanced non-small cell lung cancer; Cancer

• Registration Number: ISRCTN35543977
• Lead Sponsor: Peking University Shenzhen Hospital

Brief Summary

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34357411/ (added 09/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-09-30
• Study Start: 2021-01-26
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

1. 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

Exclusion Criteria

1. 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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-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 Measures

Name	Time	Method
<br> Data collected from the electronic medical system of Peking University Shenzhen Hospital, assessed every 6 to 12 weeks:<br> 1. Objective response rate (ORR), defined as the percentage of patients with at least one confirmed response before any evidence of progression<br> 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<br> 3. Overall survival (OS), defined as the time from the first administration to death from any cause or last follow-up<br> 4. Toxicity, as categorized and graded according to the NCI-CTCAE<br>