Actively Recruiting
Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)
Led by TYK Medicines, Inc · Updated on 2024-01-30
680
Participants Needed
2
Research Sites
286 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess the efficacy and safety of TY-9591 versus Osimertinib in patients with locally advanced or Metastatic Non Small Cell Lung Cancer.
CONDITIONS
Official Title
Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years and under 80 years
- Diagnosed locally advanced or metastatic NSCLC by histology or cytology
- Presence of activating EGFR-sensitive mutations including exon 19 deletions or L858R
- No prior systemic antitumor therapy for locally advanced or metastatic NSCLC
- At least one measurable lesion as per RECIST version 1.1
- ECOG performance status 0-1 with no deterioration 2 weeks before study and expected survival at least 3 months
- Adequate bone marrow, liver, kidney, and coagulation function
- Male and female patients of reproductive age must use effective contraception from consent to 3 months after last study drug; women of childbearing age must have negative pregnancy test within 7 days before first dose
- Recovery from prior anticancer therapy toxicities grade 1 or less (except alopecia and certain neuropathies) before first dose
- Ability to understand and voluntarily sign informed consent
- Ability to comply with study requirements
You will not qualify if you...
- Previous treatment with EGFR inhibitors or systemic antitumor therapy including targeted, biotherapy, immunotherapy
- Chemotherapy within 28 days or traditional Chinese medicine antitumor therapy within 7 days before first dose
- Radiation to more than 30% of bone marrow within 28 days or wide-field radiation completed within 28 days; limited radiation within 7 days or palliative radiation for bone metastasis
- Uncontrolled or poorly controlled pleural or abdominal effusion
- Major surgery within 28 days prior to first dose
- Use of medications or herbal supplements that strongly affect CYP3A4 enzyme within 14 days before first dose
- Use of medications that prolong QTc interval or cause tachycardia during study
- Participation in other clinical trials (except non-interventional) within 28 days before first dose
- Squamous cell carcinoma or squamous component predominance
- Symptomatic brain or leptomeningeal metastases
- Spinal cord compression caused by tumor
- Severe gastrointestinal dysfunction affecting drug absorption
- Cardiac issues including QTc interval ≥470 ms, rhythm abnormalities, risk factors for QTc prolongation, or left ventricular ejection fraction below 50%
- Active HIV, syphilis, hepatitis C or B infection except asymptomatic chronic carriers
- History of interstitial lung disease, drug-induced ILD, or radiation pneumonitis requiring steroids or active ILD
- Previous allogeneic bone marrow transplant
- Pregnant or breastfeeding women
- Any unstable disease or medical condition affecting safety or compliance
- Hypersensitivity to study drugs or similar compounds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hunan Provincial Tumor Hospital
Changsha, Hunan, China, 410013
Actively Recruiting
2
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 201203
Actively Recruiting
Research Team
B
Baohui Han, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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