NCT03743129

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

April 12, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2021

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

2.6 years

First QC Date

November 11, 2018

Last Update Submit

June 8, 2023

Conditions

Non-Small Cell Lung Cancer Stage III

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Disease Control Rate at 6 months(DCR6)

    Estimated to be from baseline up to 3 years

  • Disease Control Rate at 12 months(DCR12)

    Estimated to be from baseline up to 3 years

  • Overall Survival at 12 months (OS12)

    Estimated to be from baseline up to 3 years

  • Overall Survival at 24 months (OS24)

    Estimated to be from baseline up to 3 years

  • Recurrence rate at 12 months

    Estimated to be from baseline up to 3 years

  • +1 more secondary outcomes

Study Arms (2)

Anlotinib

EXPERIMENTAL

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

Blank

NO INTERVENTION

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

Interventions

AnlotinibDRUG

Anlotinib 12mg p.o, qd

Also known as: AL3818
Anlotinib

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The second hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Related Publications (1)

  • Yang D, Li X, Xue X, Jiang L, Shi A, Zhao J. Anlotinib hydrochloride consolidation after concurrent chemoradiotherapy in stage III non-small-cell lung cancer: a truncated, randomized, multicenter, clinical study (ALTER-L029). Anticancer Drugs. 2024 Aug 1;35(7):680-685. doi: 10.1097/CAD.0000000000001617. Epub 2024 May 3.

    PMID: 38718190DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Chief Physician

Study Record Dates

First Submitted

November 11, 2018

First Posted

November 15, 2018

Study Start

April 12, 2019

Primary Completion

November 11, 2021

Study Completion

November 11, 2021

Last Updated

June 12, 2023

Record last verified: 2023-06

Locations

CN(4)