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A Study of TY-9591 With Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor NSCLC

To Evaluate the Efficacy and Safety of TY-9591 Tablets Combined With Chemotherapy as First-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation

NCT06672068•TYK Medicines, Inc

View on ClinicalTrials.gov

Summary

This study was a parallel, randomized, multicenter phase II clinical trial to evaluate the efficacy and safety of TY-9591 combined with platinum-based chemotherapy as first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR sensitive mutations.

Detailed Description

Participants were randomly assigned in a 1:1 ratio to either cohort 1 or cohort 2 for 21-day treatment cycles until disease progression (RECIST v1.1 criteria), treatment discontinuation criteria, withdrawal criteria, or study discontinuation, whichever occurred first. After the subjects terminate or withdraw from this study, the investigators can use reasonable follow-up treatment according to the subjects' condition.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female ≥18 years old and \<80 years old.
•2. Patients with non-squamous non-small cell lung cancer (NSCLC) diagnosed by histology or cytology as locally advanced (clinical stage IIIB, IIIC, no chance of radical surgery or radical chemoradiotherapy) or metastatic (clinical stage IVA, IVB) (according to the AJCC TNM staging criteria for lung cancer, 8th edition).
•3. Tissue or blood samples tested positive for EGFR sensitive mutations (including exon 19 deletion, exon 21 L858R mutation, alone or in combination with other EGFR mutations) by central laboratory or research center, other tertiary hospitals, or third-party laboratories.
•4. He had received no previous systemic antitumor therapy for locally advanced or metastatic non-small-cell lung cancer. Patients who had received previous adjuvant and neoadjuvant therapy and definitive radiotherapy/chemoradiotherapy were allowed if the last treatment was more than 12 months after disease recurrence or metastasis.
•5. Patients had at least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) : no previous local treatment such as radiotherapy, an accurately measurable target lesion at baseline, and a baseline maximum diameter of 10mm or more (or a short diameter of 15mm or more in the case of a lymph node). For patients with postoperative recurrence, lesions in the area of previous local treatment (radiotherapy or other therapy) were considered measurable only if disease progression occurred more than 6 months after the end of treatment.
•6. With an ECOG score of 0-1 and no deterioration during the first 2 weeks of the study, survival was expected to be no less than 3 months.
•7. Patients were required to have adequate bone marrow reserve and no hepatic, renal, or coagulopathy, with laboratory values that met the following criteria (no previous blood or platelet transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) transfusion within 14 days before the first dose in this study).
•8. Male patients and female patients of reproductive age should take adequate contraceptive measures within 3 months after signing the study informed consent to the last study drug treatment; In women of childbearing age, the blood pregnancy test results were negative within 7 days before the first dose.
•9. Before the first dose of study drug, all toxic effects (except alopecia and grade 2 neurotoxicity related to prior platinum-based chemotherapy) associated with previous systemic therapy (e.g., adjuvant chemotherapy) had been resolved (to grade 1 or less).
•3. Anti-tumor therapy with traditional Chinese medicine with anti-tumor indications was received within 7 days before the first dose of the study drug.
+11 more criteria

Exclusion Criteria

•1. The following treatments exist for patients:
•1. Previous treatment with any EGFR-TKI was performed.

Key Dates

Start Date

February 20, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2028

Last Updated

December 30, 2024

Enrollment

ESTIMATED participants

Conditions

NSCLC

Interventions

TY-9591 80mg QD+pemetrexed+Cisplatin/Carboplatin

DRUG

TY-9591 160mg QD+pemetrexed+Cisplatin/Carboplatin

DRUG

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITING

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of TY-9591 With Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor NSCLC

Inclusion Criteria

Exclusion Criteria

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Magnetic Resonance Imaging of the Lung: Oncological Applications

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements