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

Primary Purpose

Non-Small Cell Lung Cancer Stage III

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Sponsored by
Anhui Shi, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer Stage III

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China-Japan Friendship Hospital
  • Beijing Cancer Hospital
  • Peking University Third Hospital
  • The second hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Anlotinib

Blank

Arm Description

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).

No intervention from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) .The 2:1 ratio (Anlotinib to blank).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
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
Recurrence rate at 12 months
the percentage of patients with Progressive Disease(PD) at 12 months after randomization
Recurrence rate at 24 months
the percentage of patients with Progressive Disease(PD) at 24 months after randomization

Full Information

First Posted
November 11, 2018
Last Updated
June 8, 2023
Sponsor
Anhui Shi, MD
Collaborators
Peking University Cancer Hospital & Institute, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03743129
Brief Title
Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（ALTER-L029）
Acronym
ALTER-L029
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2019 (Actual)
Primary Completion Date
November 11, 2021 (Actual)
Study Completion Date
November 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anhui Shi, MD
Collaborators
Peking University Cancer Hospital & Institute, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer Stage III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib
Arm Type
Experimental
Arm Description
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).
Arm Title
Blank
Arm Type
No Intervention
Arm Description
No intervention from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) .The 2:1 ratio (Anlotinib to blank).
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Other Intervention Name(s)
AL3818
Intervention Description
Anlotinib 12mg p.o, qd
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Time Frame
Estimated to be from baseline up to 3 years
Secondary Outcome Measure Information:
Title
Disease Control Rate at 6 months(DCR6)
Description
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
Time Frame
Estimated to be from baseline up to 3 years
Title
Disease Control Rate at 12 months(DCR12)
Description
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
Time Frame
Estimated to be from baseline up to 3 years
Title
Overall Survival at 12 months (OS12)
Description
the percentage of patients who are alive at 12 months after randomization per the Kaplan-Meier estimate of overall survival at 12 months
Time Frame
Estimated to be from baseline up to 3 years
Title
Overall Survival at 24 months (OS24)
Description
the percentage of patients who are alive at 24 months after randomization per the Kaplan-Meier estimate of overall survival at 24 months
Time Frame
Estimated to be from baseline up to 3 years
Title
Recurrence rate at 12 months
Description
the percentage of patients with Progressive Disease(PD) at 12 months after randomization
Time Frame
Estimated to be from baseline up to 3 years
Title
Recurrence rate at 24 months
Description
the percentage of patients with Progressive Disease(PD) at 24 months after randomization
Time Frame
Estimated to be from baseline up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
The second hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

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

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