Anlotinib Therapy in Patients With Advanced Lung Cancer.

NCT03940404 | Unknown

• 1 other identifier: ALOT-LC1
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• PFS

  progression-free survival

  1 year

Secondary Outcomes (3)

• OS

  1 year

• ORR

  1 year

• DCR

  1 year

Study Arms (1)

experiment

The patients whose treatment strategy containing anlotinib.

Drug: Anlotinib Hydrochloride

Interventions

Anlotinib Hydrochloride DRUG

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

Also known as: Other intervention depends on the patient's disease

experiment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

advanced lung caner

You may qualify if:

• Patients ≥18 years of age, man or woman, who had to provide written informed consent prior to enrollment.
• 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.
• Eastern Cooperative Oncology Group performance status of 0-2.

You may not qualify if:

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

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead
• Cttq: collaborator

Study Sites (1)

First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 300006, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shenglin Ma

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueqin Chen

CONTACT

+8613735430109; chenlucy1437@aliyun.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2019
• First Posted: May 7, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

CN (1)