Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（ALTER-L029） (ALTER-L029)

A Randomised, Open, Blank-controlled, Multi-centre Study of Anlotinib as Sequential Therapy in Patients With Unresectable NSCLC(Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy

Evaluate the efficacy and safety of Anlotinib following concurrent chemoradiation in patients with stage III unresectable non-small cell lung cancer

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer Stage III
• Intervention / Treatment: Drug: Anlotinib

Detailed Description

Anlotinib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR1、VEGFR2、VEGFR3、FGFR1/2/3、PDGFRa/β c-Kit and MET.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Dan Yang; Phone Number: 010-88196984; Email: yangdan90117@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1.Age at least 18 years.
• 2.Documented evidence of NSCLC (locally advanced, unresectable, Stage III).
• 3.Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
• 4.ECOG PS : 0 to 1.
• 5.Estimated life expectancy of more than 12 weeks.

Exclusion Criteria:

• 1.Prior exposure to any anti-angiogenesis drugs.
• 2.Central lung carcinoma along with large vessels or tumor with cavum or necrosis.
• 3.Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
• 4.Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy.
• 5.Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or COPD.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anlotinib; Anlotinib p.o, qd. Treatment from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) to disease progress or untolerated toxicity or consent withdrawal. The 2:1 ratio (Anlotinib to blank).	Drug: Anlotinib; Anlotinib 12mg p.o, qd; Other Names: AL3818
No Intervention: Blank; No intervention from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) .The 2:1 ratio (Anlotinib to blank).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)	Estimated to be from baseline up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate at 6 months(DCR6)	the percentage of patients with response of Complete Response (CR) or partial response (PR) or stable disease(SD) at least 4 weeks at 6 months after randomization	Estimated to be from baseline up to 3 years
Disease Control Rate at 12 months(DCR12)	the percentage of patients with response of Complete Response (CR) or partial response (PR) or stable disease(SD) at least 4 weeks at 12 months after randomization	Estimated to be from baseline up to 3 years
Overall Survival at 12 months (OS12)	the percentage of patients who are alive at 12 months after randomization per the Kaplan-Meier estimate of overall survival at 12 months	Estimated to be from baseline up to 3 years
Overall Survival at 24 months (OS24)	the percentage of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months	Estimated to be from baseline up to 3 years
Recurrence rate at 12 months	the percentage of patients with Progressive Disease(PD) at 12 months after randomization	Estimated to be from baseline up to 3 years
Recurrence rate at 24 months	the percentage of patients with Progressive Disease(PD) at 24 months after randomization	Estimated to be from baseline up to 3 years

Collaborators and Investigators

• Sponsor: Anhui Shi, MD
• Collaborators: Peking University Cancer Hospital & Institute; Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2019
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): November 11, 2021

Study Registration Dates

• First Submitted: November 11, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 15, 2018

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 8, 2023
• Last Verified: June 1, 2023

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
• Other Study ID Numbers: 2018YJZ47

Drug and device information, study documents

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