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Nonsmall Cell Lung CancerCSOAIMTOANNCT03769805

Clinical Study of Anlotinib in Maintenance Treatment of Advanced NSCLC

A study testing Anlotinib in people with Nonsmall Cell Lung Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Based on the need of clinical practice of maintenance therapy for advanced NSCLC and the reliable data of third-line treatment for non-small cell lung cancer, the investigators designed a clinical study of antinil hydrochloride versus pemetrexed in maintenance therapy for advanced NSCLC to prospectively evaluate the… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Nonsmall Cell Lung Cancer
What is being tested?
Anlotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteChina
Study dates
15 Jun 2019to 31 Dec 2020
Phase
Interventional
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 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • NSCLC was diagnosed by cytology or histology, and patients with stage IIIB or IV and no sensitive mutation of EGFR/ALK/ROS1 were diagnosed according to IASLC Staging Standard (IASLC 2007 9) of the 7th edition of 2009;
  • Those who had received platinum-containing two-drug combination chemotherapy for 4-6 cycles were judged as complete remission (CR), partial remission (PR) and stabilization (SD) according to RECIST 1.1 standard; (Specific schemes of platinum-containing two-drug combination chemotherapy included vinorelbine+cisplatin/carboplatin, gemcitabine+cisplatin/carboplatin, paclitaxel+cisplatin/carboplatin, albumin. Binding paclitaxel + cisplatin / carboplatin, docetaxel + cisplatin / carboplatin, pemetrexed + cisplatin / carboplatin, and squamous cell carcinoma may include docetaxel + nedaplatin)
  • Age: 18 to 74 years old, regardless of gender;
  • PS 0～1(ECOG) ;
  • The life expectancy is more than 3 months;
  • According to RECIST 1.1 criteria, patients have at least one imaging (CT, MRI) lesion that can be measured or evaluated; the lesion was not previously treated by radiotherapy. The longest diameter of the target lesion should be greater than or equal to 10 mm (the short axis of lymph node is greater than or equal to 15 mm);
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  • Patients with brain metastasis at baseline should be single intracranial metastasis, asymptomatic or asymptomatic after treatment;
  • Women: For all women who may be pregnant, pregnancy tests must be performed within 72 hours before starting treatment, or medically approved contraceptive methods must be used within three months after the treatment and during the period after the end of treatment; serum or urine pregnancy tests must be negative and must be non-lactating; Male: Contraceptive measures were taken during and within 3 months after surgical sterilization or treatment;
  • The functional level of organs must meet the following requirements:
  • Routine blood test ANC is more than 1.5 x 109/L; PLT is more than 90 x 109/L; Hb > 90g/L Blood biochemistry TBIL is less than 1.5 x ULN ALT and AST < 2 ULN; for patients with liver metastases, ALT and AST < 5 ULN; BUN and CR were less than 1.5 x ULN and creatinine clearance was more than 50 ml/min.
  • Colour Sonography LVEF is more than 50%; 12 lead electrocardiogram The Fridericia-corrected QTcF was < 450 ms for males and < 470 MS for females.
  • Subjects who have the ability to understand and sign the informed consent must sign the informed consent before any screening evaluation.

Who cannot join

  • Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption;
  • There is a third interstitial effusion (e.g. massive pleural and ascites) that cannot be controlled by drainage or other means;
  • Radiotherapy, surgical treatment, or other targeted therapy for non-small cell lung cancer was given within four weeks before the first study drug was administered;
  • Researchers judged that they had not recovered from previous adverse events before taking the drug for the first time (NCI-CTCAE Version 4.0 Grade > Grade 1);
  • Patients with multiple or active (uncontrolled) brain metastases, cancerous meningitis, spinal cord compression, or with brain or pia mater diseases detected by CT or MRI at screening time (patients with single brain metastases whose symptoms were stable and had completed treatment within 28 days prior to the first use of the research drug) may be enrolled in the group, but only through craniocerebral MRI, CT or venography. Shadow evaluation confirmed no symptoms of cerebral hemorrhage;
  • Participated in other drug clinical trials within 4 weeks before taking the first research drug;
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  • There was a history of bleeding. Within 4 weeks before screening, any bleeding events with a severe grade of 3 or more in CTCAE 4.0 occurred;
  • Having a history of thrombosis, or judging by researchers, abnormal coagulation function has clinical significance, tends to bleed, or is undergoing thrombolysis or anticoagulation therapy;
  • Hemoptysis was evident within 2 months before the first study drug was administered;
  • Patients with hypertension who could not be well controlled by a single antihypertensive drug (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); patients with a history of unstable angina pectoris; newly diagnosed angina pectoris in the first three months of screening or myocardial infarction events in the first six months of screening; arrhythmia (including QTcF: males > 450 ms, females) Long-term use of antiarrhythmic drugs and New York Heart Association Classification (> Class II) cardiac insufficiency were required;
  • Urinary routine indicated that urinary protein (++) and confirmed 24-hour urinary protein quantification > 1.0 G;
  • Long-term union of wounds or incomplete healing of fractures;
  • Other malignant tumors in the past five years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
  • Those with allergic constitution or known history of allergy to the drug components of this regimen;
  • Has a history of immunodeficiency, including HIV positive testing, or other acquired, congenital immunodeficiency disorders, or organ transplantation history;
  • The baseline pregnancy test was positive for pregnant, lactating or fertile women, and the patients of childbearing age who were unwilling to take effective contraceptive measures during the whole period of the test were unwilling to take effective contraceptive measures;
  • According to the judgement of researchers, there are concomitant diseases that seriously endanger patients'safety or affect patients' completion of research;
  • There was a clear history of neurological or psychiatric disorders, including epilepsy or dementia;
  • Researchers believe that patients are not suitable for any other situation in this study.

Trial locations and contacts

1 site in 1 country.

Yongqian Shu, PhD contact

00862568306428

shuyongqian@csco.org.cn

Yiqian Liu, PhD contact

008613813804568

China1 site, 1 recruiting

  • The First Affiliated Hospital with Nanjing Medical University

    Nanjing, Jangsu

    Yongqian Shu, Doctor

    Yiqian Liu

    Recruiting

Other trials in China

About this study

Based on the need of clinical practice of maintenance therapy for advanced NSCLC and the reliable data of third-line treatment for non-small cell lung cancer, the investigators designed a clinical study of antinil hydrochloride versus pemetrexed in maintenance therapy for advanced NSCLC to prospectively evaluate the efficacy of antinil hydrochloride in maintenance therapy for advanced NSCLC. Value, to provide a scientific basis for prolonging the survival time of patients with advanced NSCLC, improving the quality of life of patients in the course of treatment, and optimizing treatment strategies to a greater extent.

Read the detailed description

This study is planned to be carried out in Jiangsu regional multi-center. 83 cases are preliminarily expected to be included. The study started in December 2018 and ended in December 2019. It is expected that the trial will end in December 2020.

In the absence of such situations as withdrawal of informed consent, intolerance of drug toxicity and side effects, or inappropriateness for further trials, each participant's expected time for research and treatment will continue until radiographically confirmed tumor progression occurs.

Being tested
Anlotinib
Keywords
anlotinib, Maintenance treatment
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

    Anlotinib hydrochloride capsule 12 mg, orally, once a day, oral before breakfast, according to the research program for 2 weeks, discontinued for 1 week.

Study groups in NCT03769805
Study groupRoleWhat they receive
Anlotinib ArmExperimentalAnlotinib hydrochloride capsule 12 mg, orally, once a day, oral before breakfast, according to the research program for 2 weeks, discontinued for 1 week. Patients with complete remission (CR), partial remission (PR) and stable disease (SD) continued to administer drugs until the disease progressed, intolerable toxicity or withdrawal was required. Patients with progression of illness (PD) discontinued their medication.
Receives: Drug: Anlotinib

What is being measured

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

  1. PFS

    Progression free survival

    Measured: 5 month

Secondary outcomes (1)

  1. OS

    Overall survival

    Measured: through study completion, an average of 18 month

Timeline

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

  1. First posted10 Dec 2018
  2. Study start15 Jun 2019
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
83 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03769805
Sponsor's protocol ID
ALTER-L014
Acronym
CSOAIMTOAN
Status last verified
Oct 2019
First submitted
26 Nov 2018
Last updated
22 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Liu Y, Miao L, Chen X, Zhu X, Li Y, He J, Chen P, Dai S, Liu Z, Ma K, Wang N, Zhao Y, Chen N, Song W, Bai R, Cui J, Shu Y. Maintenance therapy with anlotinib after induction therapy with platinum-based chemotherapy for advanced non-small-cell lung cancer: A pooled analysis of 2 single-arm trials. Medicine (Baltimore). 2024 Jul 5;103(27):e38459. doi: 10.1097/MD.0000000000038459.

    PubMed 38968520

Questions about this trial

What is this clinical trial studying?

A study testing Anlotinib in people with Nonsmall Cell Lung Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 12 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Yongqian Shu, PhD (00862568306428, shuyongqian@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 5 month). 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 NCT03769805, 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 22 Oct 2019.

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