TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases

NCT05948813 | Recruiting Phase 2

• 1 other identifier: TYKM1601202
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the efficacy and safety of TY-9591 in first-line treatment of patients with EGFR-sensitive mutation-positive non-small cell lung cancer with brain metastases compared to Osimertinib.

Conditions

NSCLC; EGFR Activating Mutation; Brain Metastases

Outcome Measures

Primary Outcomes (2)

• 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

  36 months

• 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

  36 months

Secondary Outcomes (14)

• Objective Response Rate (ORR)

  36 months

• Median Progression Free Survival (PFS)

  36 months

• Disease Control Rate (DCR)

  36 months

• Intracranial Disease Control Rate (iDCR)

  36 months

• Depth of Response (DepOR)

  36 months

Study Arms (2)

TY-9591 Tablets

EXPERIMENTAL

TY-9591 (160mg orally, once daily), in accordance with the randomization schedule.

Drug: TY-9591

Osimertinib

ACTIVE COMPARATOR

Osimertinib (80mg orally, once daily), in accordance with the randomization schedule.

Drug: Osimertinib

Interventions

TY-9591 DRUG

The dose of TY-9591 tablet is 160 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment until meet the of discontinuation criteria.

TY-9591 Tablets

Osimertinib DRUG

The dose of Osimertinib is 80 mg once daily. A cycle of treatment is defined as 21 days of once daily treatment until meet the of discontinuation criteria.

Also known as: Tagrisso

Osimertinib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥18 years and \<80 years.
• Patients diagnosed with NSCLC by histology or cytology, with brain metastases.
• 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).
• No prior systemic antitumor therapy for locally advanced or metastatic NSCLC.
• Stable brain metastases that do not require immediate or planned local treatment for it during the study period.
• At least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
• The ECOG score is 0-1, and there is no deterioration 2 weeks before the study, and the expected survival is not less than 3 months.
• Adequate bone marrow reserve function, and no liver, kidney and coagulation dysfunction.
• 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.

You may not qualify if:

• Any of the following treatment:
• Previous treatment with EGFR inhibitor;
• Previous treatment with Systematic antitumor therapy (including targeted therapy, biotherapy and immunodrug therapy, etc.)；
• Previous treatment with standard chemotherapy with 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;
• Previous whole brain radiation therapy (WBRT); 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;
• Uncontrollable or poorly controlled pleural, abdominal and pericardial effusion;
• Uncontrollable cancerous pain; Anesthetic painkillers did not reach a stable dose at the time of enrollment;
• Major surgery within 28 days 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 primary malignant brain tumors and unstable brain metastases.
• Patients who have had or have a history of other malignancies within the past 5 years (except cured basal cell or squamous cell carcinoma of the skin, papillary carcinoma of the thyroid gland, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast).
• The patient had symptoms of spinal cord compression caused by the tumor.
• Clinically severe gastrointestinal dysfunction may affect the ingestion, transport or absorption of the study drugs.

Sponsors & Collaborators

• TYK Medicines, Inc: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

osimertinib

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yuankai Shi, MD

  Cancer Institute/Hospital, Chinese Academic of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuankai Shi, MD

CONTACT

+86-10-87788293; syuankaipum@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2023
• First Posted: July 17, 2023
• Study Start: August 17, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 30, 2027
• Last Updated: November 21, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)