NCT06672068
A Study of TY-9591 With Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor NSCLC
Not Yet Recruiting · Phase 2 · TYK Medicines, Inc · registry updated 2024-12-30
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Male or female ≥18 years old and \<80 years old.
- 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).
- 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.
- 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.
- 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.
- 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.
Exclusion
- The following treatments exist for patients:
- Previous treatment with any EGFR-TKI was performed.
- Previous systemic anti-tumor therapy for advanced/metastatic non-small cell lung cancer (including chemotherapy, targeted therapy, biological therapy, immunotherapy, etc.), neoadjuvant and adjuvant therapy, definitive radiotherapy/chemoradiotherapy were eligible according to the inclusion criteria
- Anti-tumor therapy with traditional Chinese medicine with anti-tumor indications was received within 7 days before the first dose of the study drug.
- Prior whole brain radiotherapy (WBRT); Received \>30% bone marrow or extensive radiation within 28 days before the first dose of study drug; Local radiotherapy or palliative radiotherapy for bone metastases had been administered within 7 days before the first dose of study drug.
- Uncontrolled or poorly controlled pleural effusion and pericardial effusion.