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Non-Small Cell Lung Cancer Stage IIIPhase 2ALTER-L029NCT03743129

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

A Phase 2 study testing Anlotinib in people with Non-Small Cell Lung Cancer Stage III, run by Anhui Shi, MD at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Non-Small Cell Lung Cancer Stage III
What is being tested?
Anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
4 sitesChina
Study dates
12 Apr 2019to 11 Nov 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The second hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

Other trials in China

About this study

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

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

Read the 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.

Being tested
Anlotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnlotinibDrug

    Also called AL3818

    Anlotinib 12mg p.o, qd

Study groups in NCT03743129
Study groupRoleWhat they receive
AnlotinibExperimentalAnlotinib 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).
Receives: Drug: Anlotinib
BlankNo interventionNo intervention from Day 1 of randomization(after concurrent chemoradiation 4-6 weeks) .The 2:1 ratio (Anlotinib to blank).

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Estimated to be from baseline up to 3 years

Secondary outcomes (6)

  1. 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

    Measured: Estimated to be from baseline up to 3 years

  2. 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

    Measured: Estimated to be from baseline up to 3 years

  3. 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

    Measured: Estimated to be from baseline up to 3 years

  4. 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

    Measured: Estimated to be from baseline up to 3 years

  5. Recurrence rate at 12 months

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

    Measured: Estimated to be from baseline up to 3 years

  6. Recurrence rate at 24 months

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

    Measured: Estimated to be from baseline up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2018
  2. Study start12 Apr 2019
  3. Primary completion11 Nov 2021
  4. Study completion11 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03743129
Sponsor's protocol ID
2018YJZ47
Acronym
ALTER-L029
Status last verified
Jun 2023
First submitted
11 Nov 2018
Last updated
12 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38718190

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib in people with Non-Small Cell Lung Cancer Stage III, run by Anhui Shi, MD at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Estimated to be from baseline up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03743129, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.

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