Anlotinib Therapy in Patients With Advanced Lung Cancer.

• Conditions: Lung Neoplasms
• Interventions: Drug: Anlotinib Hydrochloride

• Registration Number: NCT03940404
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

Purpose of the study: To observe the efficacy and safety of Anlotinib Hydrochloric Therapy in Patients with advanced Lung cancer in real world.

Subjects of the study: advanced Lung cancer.

Methods of the study:

This is a real world, prospective, Non-Interventional, Follow-up registration study.

Patients will get Anlotinib according to their condition and willingness. Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. After the procedure, regular follow up after every cycle.

End point:

Primary end point: progression-free survival (PFS). Secondary end points: overall survival (OS), disease control rate (DCR), overall response rate (ORR).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-27
• Status Verified: 2019-05
• Study Start: 2019-05
• Study First Submitted QC: 2019-05-04
• Last Update Submitted: 2019-05-04
• Study First Posted: 2019-05-07
• Last Update Posted: 2019-05-07
• Primary Completion: 2020-05
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Patients ≥18 years of age, man or woman, who had to provide written informed consent prior to enrollment.
2. Patients who had to have histologically and/or cytologically confirmed NSCLC that failed at least 2 kinds of systemic chemotherapy (third line or beyond), or who will obtain benefit from antiangiogenic therapy after investigator's assessment.
3. Eastern Cooperative Oncology Group performance status of 0-2.

Exclusion Criteria

1. Contraindication of anlotinib.
2. Pregnant or lactating women.
3. Other patients who can't enroll after investigator's assessment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
experiment	Anlotinib Hydrochloride	The patients whose treatment strategy containing anlotinib.

Primary Outcome Measures

Name	Time	Method
PFS	1 year	progression-free survival

Secondary Outcome Measures

Name	Time	Method
DCR	1 year	disease control rate
OS	1 year	overall survival
ORR	1 year	overall response rate

Trial Locations

Locations (1)

First People's Hospital of Hangzhou; 🇨🇳 Hangzhou, Zhejiang, China