Anlotinib Therapy in Patients With Advanced Lung Cancer.

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

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).

Study Overview

• Status: Unknown
• Conditions: Lung Neoplasms
• Intervention / Treatment: Drug: Anlotinib Hydrochloride

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 300006
      • Recruiting
      • First People's Hospital of Hangzhou
      • Contact: Xueqin Chen; Phone Number: +8613735430109; Email: chenlucy1437@aliyun.com
      • Sub-Investigator: Xueqin Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

advanced lung caner

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
experiment; The patients whose treatment strategy containing anlotinib.	Drug: Anlotinib Hydrochloride; Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. Dose reduction is allowed.; Other Names: Other intervention depends on the patient's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression-free survival	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	overall survival	1 year
ORR	overall response rate	1 year
DCR	disease control rate	1 year

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou
• Collaborators: Cttq

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: April 27, 2019
• First Submitted That Met QC Criteria: May 4, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 4, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: ALOT-LC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No