Evaluating Anlotinib Combined With Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy Versus Concurrent Chemoradiotherapy Followed by Consolidation Immunotherapy for Locally Advanced Non-small Cell Lung Cancer: A Prospective, Randomized Controlled Phase II Clinical Trial

Sun Yat-sen University1 site in 1 countryApril 1, 2022

ConditionsLocally Advanced Non-small Cell Lung Cancer Efficacy and Safety

InterventionsAnlotinib Chemotherapy Radiotherapy Immunotherapy

DrugsAnlotinib Chemotherapy Immunotherapy

Overview

Phase: Phase 2
Intervention: Anlotinib
Conditions: Locally Advanced Non-small Cell Lung Cancer
Sponsor: Sun Yat-sen University
Locations: 1
Primary Endpoint: 18-months progression-free survival rate
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

This is a prospective, randomized, controlled phase II clinical study for evaluating anlotinib combined with concurrent chemoradiotherapy followed by consolidation immunotherapy versus concurrent chemoradiotherapy followed by consolidation immunotherapy in locally advanced, unresectable NSCLC. In this study, the enrolled patients were divided into the experimental group and the control group at a ratio of 1:1. The patients in the experimental group received anlotinib combined with curative concurrent chemoradiotherapy first, while the patients in the control group received curative concurrent chemoradiotherapy. Those who are evaluated as CR, PR or SD after the aforementioned treatment will enter consolidation immunotherapy. Patients will receive tislelizumab 200mg iv. drip, Q3W, for up to 12 months.

Registry

clinicaltrials.gov

Start Date

April 1, 2022

End Date

September 30, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Hui Liu

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•informed consent is required before proceeding with any steps in the study;
•Male or female 18-75 years old;
•Patients must be locally advanced, unresectable (stage IIIA-IIIC) with histology reported NSCLC (except for central squamous cell carcinoma or those at risk for massive hemoptysis);
•No prior chemotherapy, immunotherapy, radiotherapy, surgery, or targeted therapy;
•Tumor sample requirements: must provide sufficient evidence to allow analysis Stained, archived tumor tissue samples;
•Life expectancy ≥ 12 weeks;
•World Health Organization (WHO) PS score of 0 or 1;
•Postmenopausal women, or negative urine or serum pregnancy test (HCG) within 14 days prior to study drug administration
•Women of childbearing potential (WOCBP) must agree to adhere to contraceptive methods during study drug treatment and for 6 months after the last study drug treatment;
•Men who have sex with WOCBP must agree to adhere to contraception during study drug treatment and for 6 months after the last study drug treatment;

Exclusion Criteria

•Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study;
•Histological type of small cell lung cancer (including mixed small cell and non-small cell lung cancer);
•Prior use of any targeted therapy;
•The central cavity squamous cell carcinoma or non-small cell lung cancer with hemoptysis (the amount of hemoptysis\> 50 ml/d);
•The patient has conditions that affect oral medication (such as dysphagia, chronic diarrhea, intestinal obstruction, etc.) ;
•Major surgery (excluding vascular access) within 4 weeks prior to study entry;
•Heart rate-corrected mean QT interval (QTc) ≥ 470 ms, calculated from 3 electrocardiogram calculation cycles (ECG) using Bazett correction;
•No Controlled complications, including but not limited to persistent or active infection, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmia, active peptic ulcer disease or gastritis, active hemorrhagic Illness, including any known HBsAg-positive patient with HBV DNA \> 500 IU/ml, Hepatitis C or Human Immunodeficiency Virus (HIV), or mental illness that would limit compliance with study requirements or impair the patient's ability to give written informed consent/ Social status;
•History of another primary malignancy within 5 years prior to initiation of therapy, excluding adequately treated skin basal or squamous cell carcinoma or cervical carcinoma in situ;
•Pregnant, breastfeeding women; Contraceptive method, male or female of reproductive potential; - Conditions that may interfere with the evaluation of the efficacy or safety of the treatment.