Anlotinib Therapy in Patients With Advanced Lung Cancer.

Lung Neoplasms Clinical Trial

Official title:

Anlotinib Hydrochloride Therapy in Patients With Advanced Lung Cancer: A Real World Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940404
• Other study ID #: ALOT-LC1
• Status: Recruiting
• Start date: May 2019
• Est. completion date: December 2020

Study information

• Verified date: May 2019
• Source: First People's Hospital of Hangzhou
• Contact: Xueqin Chen
• Phone: +8613735430109
• Email: chenlucy1437[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Drug:
• Anlotinib Hydrochloride
Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. Dose reduction is allowed.

Locations

Country	Name	City	State
China	First People's Hospital of Hangzhou	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou	Cttq

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	progression-free survival	1 year
Secondary	OS	overall survival	1 year
Secondary	ORR	overall response rate	1 year
Secondary	DCR	disease control rate	1 year