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Completed

NCT Number: NCT03743129

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

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

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Key information

Conditions

Non-small Cell Lung Cancer Stage III Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anlotinib

Drug

Anlotinib 12mg p.o, qd

Other names: AL3818

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Estimated to be from baseline up to 3 years

    the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)

Secondary outcomes

  1. Disease Control Rate at 6 months(DCR6)

    Time frame: Estimated to be from baseline up to 3 years

    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

  2. Disease Control Rate at 12 months(DCR12)

    Time frame: Estimated to be from baseline up to 3 years

    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

  3. Overall Survival at 12 months (OS12)

    Time frame: Estimated to be from baseline up to 3 years

    the percentage of patients who are alive at 12 months after randomization per the Kaplan-Meier estimate of overall survival at 12 months

  4. Overall Survival at 24 months (OS24)

    Time frame: Estimated to be from baseline up to 3 years

    the percentage of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months

  5. Recurrence rate at 12 months

    Time frame: Estimated to be from baseline up to 3 years

    the percentage of patients with Progressive Disease(PD) at 12 months after randomization

  6. Recurrence rate at 24 months

    Time frame: Estimated to be from baseline up to 3 years

    the percentage of patients with Progressive Disease(PD) at 24 months after randomization

Sponsors and collaborators

Lead sponsor

Anhui Shi, MD

Other

Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
  • Peking University Cancer Hospital & Institute

Registry information

Official study title

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

Acronym: ALTER-L029

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 15, 2018
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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