The Efficacy and Safety of Anlotinib Combined With Nivolumab as a Second-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer

The First Affiliated Hospital with Nanjing Medical University0 sites70 target enrollmentJanuary 1, 2020

ConditionsNon Small Cell Lung Cancer

InterventionsAnlotinib Nivolumab

DrugsAnlotinib Nivolumab

Overview

Phase: Phase 2
Intervention: Anlotinib
Conditions: Non Small Cell Lung Cancer
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Enrollment: 70
Primary Endpoint: Progression-Free Survival (PFS)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study evaluates the safety and efficacy of anlotinib in combination with nivilumab as second-line treatment in advanced NSCLC patients. The primary endpoint of the study is progression-free survival (PFS);the secondary endpoints are disease control rate (DCR), objective response rate (ORR), overall survival (OS) and safety.

Registry

clinicaltrials.gov

Start Date

January 1, 2020

End Date

January 1, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female patients aged 18-75 years old;
•ECOG PS：0-1,Expected Survival Time: Over 3 months;
•Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC, with measurable nidus(using RECIST 1.1);
•For local advanced or advanced NSCLC, disease progression occurred after first-line systemic treatment previously;
•The negative patients in EGFR\&ALK can participate or who positive in EGFR\&ALK, have or have not drug tolerance after the treatment with relative targeted drugs;
•main organs function is normal;
•Signed and dated informed consent.

Exclusion Criteria

•have used Anlotinib before;
•Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer);
•examined as positive in EGFR\&ALK mutation detection and never take the treatment of TKIs;
•Previously (within 5 years) or presently suffering from other malignancies;
•Symptomatic or uncontrolled brain metastases;
•Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication;
•Pregnancy or lactation.

Arms & Interventions

anlotinib plus nivolumab

Intervention: Anlotinib

anlotinib plus nivolumab

Intervention: Nivolumab

Outcomes

Primary Outcomes

Progression-Free Survival (PFS)

Time Frame: 6 months

PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.

Secondary Outcomes

Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Until 30 day safety follow-up visit)
Objective Response Rate (ORR)(each 42 days up to intolerance the toxicity or PD (up to 12 months))
Disease control rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 12 months))
Overall Survival (OS)(12 months)