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NSCLCPhase 2NCT05146219

Study of TY-9591 in Patients With a Lung Cancer With Brain or Leptomeningeal Metastases With EGFR Mutation

A Phase 2 study testing TY-9591 Tablets in people with NSCLC and EGFR Activating Mutation, run by TYK Medicines, Inc at 1 site 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

To evaluate the efficacy and safety of TY-9591 tablets in the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC) patients with brain or leptomeningeal metastases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, EGFR Activating Mutation, Brain Metastases
What is being tested?
TY-9591 Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
2 Apr 2022to 13 Nov 2024
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with non-small cell lung cancer (NSCLC) by histology or cytology, and with brain and leptomeningeal metastases. For LM patients, the diagnosis of leptomeningeal metastasis requires detection of cancer cell or EGFR mutation in the CSF.
  • Presence of an activating EGFR-sensitive mutations (including exon 19 deletions, L858R, the above mentioned mutations alone or co-existed with other EGFR-mutated sites). A positive T790M mutation is required for patients who have progressed following prior 1/2 generation EGFR-TKI therapy.
  • Stable brain/leptomeningeal metastases that do not require immediate or planned local treatment for it during the study period.
  • Presence of intracranial and extracranial measurable lesions without local treatment at the same time.
  • The ECOG score is 0-2 (including 0 and 2), and there is no deterioration 2 weeks before the study, and the expected survival is not less than 3 months.
  • Adequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:
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  • Absolute neutrophil count ≥1.5×109/L and white blood cell count ≥3×109/L;
  • Platelet count ≥100×109/L;
  • Hemoglobin ≥90g/L;
  • Serum creatinine ≤1.5× upper normal limit (ULN) and creatinine clearance ≥50 mL/min (calculated according to the Cockcroft and Gault formula);
  • AST and ALT≤2.5×ULN if no confirmed liver metastasis; AST, ALT≤5×ULN if confirmed liver metastasis;
  • Total bilirubin ≤1.5×ULN in the absence of proven liver metastasis; total bilirubin ≤3×ULN in patients with proven liver metastasis or Gilbert syndrome (hyperindirect bilirubinemia);
  • International standardized ratio (INR) ≤1.5, and activated partial prothrombin time (APTT) ≤1.5×ULN.
  • Male patients and female patients of reproductive age should take adequate contraceptive measures from signing informed consent to 3 months after the last study drug treatment; Women of childbearing age have negative pregnancy test results within 7 days of the first dose.
  • Patients having recovered from all grade ≤ 1 toxicities related to previous anticancer therapies (CTCAE v 5.0) except for alopecia, platinum-therapy-related neuropathy (where ≤2 is allowed) before first dose of study treatment.
  • Patients can understand and voluntarily sign the informed consent form.
  • Patient able to comply with study requirements.

Who cannot join

  • Any of the following treatment:
  • Previous treatment with 3rd generation EGFR inhibitor (Osimertinib, Almonertinib, Furmonertinib, etc.)；
  • The time from the treatment of reversible EGFR-TKI (e.g., Gefitinib, Erlotinib, Icotinib) to the first administration of the drug in this study did not exceed 8 days or 5 half-lives (whichever is longer); the time from the treatment of irreversible EGFR-tkis (e.g., Afatinib, Dacomitinib, Neratinib, etc.) do not exceed 14 days or 5 half-lives (whichever is longer)；
  • Previous treatment with Systematic antitumor therapy, including standard chemotherapy, biotherapy and immunodrug therapy within 28 days before the first dose of the study drug, and traditional Chinese medicine antitumor therapy within 7 days before the first dose of the study drug.
  • Receiving radiation to more than 30% of the bone marrow or with a wide field of radiation that had to be completed within 28 days of the first dose of study treatment; Radiotherapy with a limited field of radiation within 7 days of the first dose of study treatment or palliative radiation therapy for bone metastasis;
  • Previous treatment with whole brain radiotherapy (WBRT). Patients who have previously received stereotactic radiotherapy (SRT) or other CNS local treatments (such as intrathecal chemotherapy) can be enrolled if the time from the completion of treatment to the initial study medication is more than 2 weeks;
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  • Uncontrollable pleural and abdominal effusion. For patients with pleural effusion, pleural effusion should be stabilized for 2 weeks prior to initial medication (diuretics, pleural effusion or pleural infusion are not allowed during this period);
  • Major surgery within 4 weeks of the first dose of study treatment;
  • Patients currently receiving (or at least within 14 days prior to receiving the first dose )medications or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 isoenzyme (CYP)3A4.
  • Patients who are receiving and need to continue receiving medications during the study that are known to prolong the QTc interval or may cause tachycardia;
  • Participants in other clinical trials (other than non-interventional clinical trials) within 28 days prior to the first administration of the investigational drug.
  • Patients with leptomeningeal metastases (LM) who cannot be examined with enhanced MRI. Presence of leptomeningeal metastases only.
  • Patients with CNS complications requiring emergency neurosurgical treatment (e.g. surgery, etc.). Patients with CNS symptoms should be controlled by glucocorticoids with an equivalent dose of more than 5mg dexamethasone 5 days prior to initial administration.
  • Patients have spinal cord compression caused by tumor.
  • Clinically severe gastrointestinal dysfunction may affect the ingestion, transport or absorption of the study drugs.
  • Cardiac function and disease are consistent with the following:
  • Corrected QT interval(QTc)> 470 milliseconds from 3 electrocardiograms (ECGs);
  • Any clinically important abnormalities in rhythm;
  • Any factors that increase the risk of QTc prolongation;
  • Left ventricular ejection fraction (LVEF) <50%.
  • Active human immunodeficiency virus (HIV), syphilis, hepatitis c virus (HCV) or hepatitis b virus (HBV) infection, with the exception of asymptomatic chronic hepatitis b or hepatitis c carriers.
  • Previous history of interstitial lung disease(ILD)#drug-induced ILD or radiation pneumonitis require steroid treatment, or any evidence of clinically active ILD diseases.
  • Previous allogeneic bone marrow transplant.
  • Pregnant or lactating women.
  • Any other disease or medical condition that is unstable or may affect the safety or study compliance.
  • Hypersensitivity to TY-9591 or similar compounds or excipients.

Trial locations and contacts

1 site in 1 country.

China1 site

  • National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: A Phase II, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain or Leptomeningeal Metastases

To evaluate the efficacy and safety of TY-9591 tablets in the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC) patients with brain or leptomeningeal metastases.

Read the detailed description

This is an open label, multi-center phase II study to evaluate the efficacy and safety in EGFR mutated NSCLC patients with brain or leptomeningeal metastases. The patients will be assigned to the appropriate treatment cohorts based on the criteria.

Being tested
TY-9591 Tablets
Medical subject headings
Brain Neoplasms, Meningeal Carcinomatosis

What participants receive

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

  • TY-9591 TabletsDrug

    Also called TY-9591

    TY-9591 Tablets 160mg/d

Study groups in NCT05146219
Study groupRoleWhat they receive
TY-9591 TabletsExperimentalTY-9591 Tablets 160mg/d
Receives: Drug: TY-9591 Tablets

What is being measured

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

  1. Intracranial Overall Response Rate (iORR)

    iORR is defined as the proportion of patients with a best intracranial response of complete response (CR) or partial response (PR) during the study treatment

    Measured: 13 months.

  2. Extracranial Overall Response Rate (eORR)

    eORR is defined as the proportion of patients with a best extracranial response of complete response (CR) or partial response (PR) during the study treatment

    Measured: 13 months.

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) during the study treatment

    Measured: 13 months.

  2. Disease Control Rate (DCR)

    DCR is defined as the proportion of patients with a best overall response of complete response (CR) , partial response (PR) or Stable disease (SD) ≥6 weeks during the study treatment

    Measured: 13 months.

  3. Duration of Response (DoR)

    DoR is defined as the time from the date of first documented response (PR or CR) until the date of first documented disease progression or death due to any cause during the study treatment

    Measured: 13 months.

  4. Median Progression Free Survival (PFS)

    PFS is defined as time from date of first dose of study treatment until the date of first documented disease progression or death due to any cause

    Measured: 13 months.

  5. Intracranial Median Progression Free Survival (iPFS)

    iPFS is defined as time from date of first dose of study treatment until the date of first documented intracranial disease progression or death due to any cause

    Measured: 13 months.

  6. Overall Survival (OS)

    OS is defined as the time from the date of first dose of study treatment until death from any cause

    Measured: From the date of first dose until the date of death from any cause or loss to follow-up, whichever comes first, assessed up to 100 months

Timeline

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

  1. First posted6 Dec 2021
  2. Study start2 Apr 2022
  3. Primary completion21 Mar 2024
  4. Study completion13 Nov 2024

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05146219
Sponsor's protocol ID
TYKM1601201
Status last verified
Dec 2024
First submitted
10 Nov 2021
Last updated
30 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TY-9591 Tablets in people with NSCLC and EGFR Activating Mutation, run by TYK Medicines, Inc 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 17 inclusion and 26 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 30 Dec 2024. 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?

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?

Intracranial Overall Response Rate (iORR) (time frame: 13 months.). The study lists 2 primary outcomes in all. 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 NCT05146219.

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 30 Dec 2024.

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