Anlotinib Combined With Nivolumab for Non-Small Cell Lung Cancer

NCT04211896 | Unknown Phase 2

• 1 other identifier: ANPD1-001
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Until 30 day safety follow-up visit

Study Arms (1)

anlotinib plus nivolumab

EXPERIMENTAL

Drug: Anlotinib; Drug: Nivolumab

Interventions

Anlotinib DRUG

Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.

anlotinib plus nivolumab

Nivolumab DRUG

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.

anlotinib plus nivolumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib; Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Renhua Guo, MD

CONTACT

025-68136360; rhguo@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 26, 2019
• Study Start: January 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: January 1, 2022
• Last Updated: December 26, 2019

Record last verified: 2019-12