Anlotinib Combined With Nivolumab for Non-Small Cell Lung Cancer

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

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.

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Anlotinib; Drug: Nivolumab

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Renhua Guo, MD; Phone Number: 025-68136360; Email: rhguo@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female patients aged 18-75 years old;
2. ECOG PS：0-1,Expected Survival Time: Over 3 months;
3. Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC, with measurable nidus(using RECIST 1.1);
4. For local advanced or advanced NSCLC, disease progression occurred after first-line systemic treatment previously;
5. 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;
6. main organs function is normal;
7. Signed and dated informed consent.

Exclusion Criteria:

1. have used Anlotinib before;
2. Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer);
3. examined as positive in EGFR&ALK mutation detection and never take the treatment of TKIs;
4. Previously (within 5 years) or presently suffering from other malignancies;
5. Symptomatic or uncontrolled brain metastases;
6. 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;
7. Pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anlotinib plus nivolumab	Drug: Anlotinib; Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.; Drug: Nivolumab; Nivolumab will be given at a dose of 240 mg every 2 weeks (Odd Cycles: Days 1 and 15 and Even Cycles Day 8) per 21 day Cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Until 30 day safety follow-up visit
Disease control rate (DCR)	Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).	each 42 days up to intolerance the toxicity or PD (up to 12 months)
Overall Survival (OS)	OS is calculated from diagnosis to death or last follow-up time.	12 months
Objective Response Rate (ORR)	Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)	each 42 days up to intolerance the toxicity or PD (up to 12 months)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 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; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: ANPD1-001

Drug and device information, study documents

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