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AzTrials

NSCLCPhase 2NCT03801200

Apatinib Combined With Radiotherapy in Patient With BM From Drive Gene Negative NSCLC

A Phase 2 study testing Apatinib in people with NSCLC, run by Hubei Cancer Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to evaluate the efficacy and safety of concurrent radiotherapy with Apatinib in patients with Brain Metastases from drive gene wide-type Non-small-cell Lung Cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC
What is being tested?
Apatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
10 Sep 2020to 10 Sep 2023
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-75 years old, male or female, signed informed consent;
  • The primary lesion is confirmed by histopathology. The patient with brain metastases confirmed by histopathology or imaging confirmed the brain metastases. All patients with non-small cell lung cancer brain metastases should be recommended for EGFR mutation and ALK gene rearrangement assay，exclusion of patients with NSCLC brain metastases with positive EGFR-sensitive mutations and ALK gene rearrangement detection for TKI treatment; After multidisciplinary consultation and evaluation, patients with single or local multiple metastatic tumors with well-controlled primary lesions, who have the economic ability and are willing to undergo surgery for brain metastatic tumors were excluded.
  • Observable imaging data such as CT, MRI, etc., have measurable lesions as defined by RECIST 1.1 (R09-0262);
  • ECOG PS score: 0-2;
  • Hemogram index: RBC≥3.0×1012/L, WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥100×109/L, Hb≥90g/L
  • the expected survival time ≥ 3 months
  • Renal function: Cr≤1.2×UNL (upper limit of normal value);
  • Liver function: total bilirubin ≤ 1.5 × UNL; ALT, AST ≤ 1.5 × UNL

Who cannot join

  • . Allergies, known to be hypersensitive to any excipients in the study drug. ;
  • . Patients with recurrent brain metastases have previously received brain radiation therapy
  • . Patients with high fever and acute infection;
  • . Patients with active, progressive bleeding or a significant bleeding tendency in the primary lesion;
  • . Participated in any clinical trial of research drugs within 4 weeks prior to enrollment
  • . Diarrhea is the main symptom of the important or newly diagnosed acute gastrointestinal diseases, such as Crohn's disease, malabsorption or any cause of CTC ≥ 2 grade diarrhea.
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  • . Current clinically relevant cardiovascular disease or medical history, such as refractory hypertension, NYHA grade 3 congestive heart failure, unstable angina or poorly controlled arrhythmias. Myocardial infarction occurred 6 months before randomization.
  • . Absolute neutrophil count <1000/mm3;
  • . Platelet count <50000/mm3;
  • . According to the investigator's point of view, any other serious disease or organ system dysfunction that may affect patient safety or interfere with the safety assessment of the test drug, such as proteinuria (CTCAE4.0-≥3), severe liver and kidney dysfunction (CTCAE4.0-≥3), hand-foot syndrome (CTCAE4.0-≥3) and so on.
  • . There are ulcers, intestinal perforations, and intestinal obstruction.
  • . Pregnant and lactating women
  • . Suspected or indeed have a history of alcohol and drug abuse

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hubei Cancer hospital

    Wuhan, Hubei, 430079

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized Controlled Trial of Apatinib Combined With Radiotherapy in Patient With Brain Metastases From Drive Gene Negative NSCLC

The purpose of this study is to evaluate the efficacy and safety of concurrent radiotherapy with Apatinib in patients with Brain Metastases from drive gene wide-type Non-small-cell Lung Cancer (NSCLC).

Read the detailed description

Brain metastases (BM) develop in 22-54% of NSCLC patients during the disease course. NSCLC patients with BM with a median overall survival (OS) of 2-3 months when treated with systemic corticosteroid alone, and a median OS of 3-6 months when treated with whole brain radiation therapy (WBRT). Recently, several studies have reported the benefits of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) for EGFR mutation NSCLC patients with BM. The median OS of EGFR mutation patients with BM significantly improved with TKIs treatment, which ranged from 11.8 to 18.8 months. However, for the EGFR wide-type NSCLC patients with BM, the prognosis remains poor.

It was found that the combination of anti-VEGF drugs and brain radiotherapy can not only reduce the volume of peritumoral brain edema (PTBE), reduce the intracranial pressure, relieve the symptoms of nerve compression, reduce the risk of brain hernia during brain radiotherapy, and but also inhibit the hypoxia of tumor cells, increase the radiosensitivity of tumor cells, and ultimately improve the efficacy of radiotherapy.

Apatinib, a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor (VEGFR) and mildly inhibits c-Kit and c-SRC, has been reported to show efficacy among some patients with malignant supratentorial gliomas.

Therefore, the investigators initiated this study to evaluate the efficacy and safety of concurrent radiotherapy with Apatinib in patients with Brain Metastases from drive gene wide-type Non-small-cell Lung Cancer (NSCLC).

Conditions
NSCLC
Being tested
Apatinib
Keywords
Brain metastasis, Apatinib, Radiotherapy, NSCLC, Drive gene negative
Medical subject headings
Brain Neoplasms

What participants receive

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

  • ApatinibDrug

    Also called Apatinib Mesylate

    radiotherapy with Apatinib

Study groups in NCT03801200
Study groupRoleWhat they receive
Apatinib combined with RadiotherapyExperimentalDrugs: Apatinib Apatinib (500 mg/d) was given orally for one week before the brain radiotherapy, and then, continued to be administered at the same way during the brain radiotherapy period (3 weeks). It was given for another one week after the end of the brain radiotherapy. Radiotherapy: Intensity-modulated radiotherapy (IMRT). According to the patients KPS score, GPA score, the number and size of metastatic lesions can be selected: 1. 37.5Gy/15 fractions of whole brain irradiation for multiple brain metastases were more than 5; 2. The whole brain was irradiated with 37.5Gy/15 and simultaneous integrated boost dose of 52.5Gy/15 to patients with 1-5 metastatic lesions.
Receives: Drug: Apatinib
Radiotherapy aloneNo interventionRadiotherapy: Intensity-modulated radiotherapy (IMRT). According to the patients KPS score, GPA score, the number and size of metastatic lesions can be selected: 1. 37.5Gy/15 fractions of whole brain irradiation for multiple brain metastases were more than 5; 2. The whole brain was irradiated with 37.5Gy/15 and simultaneous integrated boost dose of 52.5Gy /15 to patients with 1-5 metastatic lesions.

What is being measured

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

  1. Intracranial progression-free survival (iPFS)

    Defined as the time from randomisation to progression of intracranial disease or death from any cause.

    Measured: Evaluated in 24 months since the treatment began

Secondary outcomes (5)

  1. Disease control rate (DCR)

    Proportion of patients with reduction or keeping in stable in tumor burden of a predefined amount

    Measured: 4 weeks after Radiotherapy.

  2. Objective response rate (ORR)

    Proportion of patients with reduction in tumor burden of a predefined amount

    Measured: 4 weeks after Radiotherapy.

  3. intracranial time to progress (ITTP)

    Defined as the time from randomisation to progression of intracranial disease

    Measured: Tumor assesment at 4 weeks and 12 weeks after radiotherapy, and then every 12 weeks, up to 24 months

  4. Overall survival (OS)

    Defined as the time from randomisation to death from any cause

    Measured: Tumor assesment at 4 weeks and 12 weeks after radiotherapy, and then every 12 weeks, up to 24 months

  5. Rate of Peritumoalbrainedema (PTBE)

    PTBE volume was measured in a similar manner by measuring the high SI region in T2WI that was clearly distinguished from normal tissues, including the tumor. Edema index was calculated by dividing the PTBE volume by tumor volume. The Edema index represents the degree of the PTBE, compared to tumor volume, with an index of 1.0 indicating no PTBE development.

    Measured: 4 weeks after Radiotherapy.

Timeline

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

  1. First posted11 Jan 2019
  2. Study start10 Sep 2020
  3. Primary completion10 Sep 2021
  4. Study completion10 Sep 2023 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03801200
Sponsor's protocol ID
HBCH RT-2019-01
Status last verified
Feb 2022
First submitted
30 Dec 2018
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ma J, Pi G, Bi J, Li Y, He H, Li Y, Hu D, Verma V, Han G. Concurrent Apatinib and Brain Radiotherapy in Patients With Brain Metastases From Driver Mutation-negative Non-small-cell Lung Cancer: Study Protocol for an Open-label Randomized Controlled Trial. Clin Lung Cancer. 2021 Mar;22(2):e211-e214. doi: 10.1016/j.cllc.2020.10.007. Epub 2020 Oct 21.

    PubMed 33187916

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with NSCLC, run by Hubei Cancer Hospital 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 8 inclusion and 13 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 8 Feb 2022. 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.

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?

Results are not available in the source record.

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?

Intracranial progression-free survival (iPFS) (time frame: Evaluated in 24 months since the treatment began). 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 NCT03801200, 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 8 Feb 2022.

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