Non-Small Cell Lung Cancer (NSCLC) Clinical Trials

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A Phase II Study of TY-9591 Tablets in Patients With EGFR-Mutated Non-small Cell Lung Cancer With Brain Metastases

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College
RECRUITING
Beijing
Contact Information
Primary
Yuankai Shi, MD
syuankaipum@126.com
+86-10-87788293
Time Frame
Start Date: 2023-08-17
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 420
Treatments
Experimental: TY-9591 Tablets
TY-9591 (160mg orally, once daily), in accordance with the randomization schedule.
Active_comparator: Osimertinib
Osimertinib (80mg orally, once daily), in accordance with the randomization schedule.
Sponsors
Leads: TYK Medicines, Inc

This content was sourced from clinicaltrials.gov