Actively Recruiting
Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC
Led by Shouyao Holdings (Beijing) Co. LTD · Updated on 2023-09-21
120
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase III, open-label, single-arm, multicenter study designed to evaluate the anti-tumor activity and safety of SY-5007 administered orally to participants with locally advanced or metastatic RET-positive NSCLC.
CONDITIONS
Official Title
Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, at least 18 years old
- Confirmed diagnosis of locally advanced or metastatic non-small cell lung cancer (NSCLC)
- No prior systemic antitumor therapy for locally advanced or metastatic NSCLC except adjuvant therapy or radical radiotherapy completed at least 6 months before first dose
- RET fusion positive confirmed by local or central laboratory testing using next-generation sequencing
- At least one measurable lesion per RECIST version 1.1 (except only measurable brain lesions)
- ECOG performance status score of 0 to 1
- Life expectancy of at least 3 months
- Adequate bone marrow, liver, renal, and coagulation function as defined in the study
- Ability to swallow oral medication and comply with follow-up visits
- Patients of childbearing potential must agree to use contraception during the study and for at least 3 months after last dose
You will not qualify if you...
- Presence of known major driver genetic alterations other than RET (e.g., EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C)
- Allergy to any components or excipients of SY-5007 tablets
- Other malignancies treated except cured malignancies without recurrence within 2 years, basal cell or squamous cell skin cancer, or carcinoma in situ of cervix or breast
- Symptomatic primary CNS tumor, symptomatic CNS metastases, molluscum contagiosum, or untreated spinal cord compression; stable CNS disease allowed with specified conditions
- Poorly controlled infections, effusions, diabetes, thyroid disorders, electrolyte disorders, or severe gastrointestinal disorders
- Serious cardiovascular disease or abnormalities including prolonged QTcF, low LVEF, recent myocardial infarction or unstable angina, severe arrhythmias, severe heart failure, poorly controlled hypertension
- Active viral infections including hepatitis B with high viral load, positive HIV test, immune deficiency disorders, prior organ or stem cell transplantation
- Other significant lung diseases requiring systemic treatment or serious conditions
- Use of potent CYP3A4 inhibitors or inducers within 2 weeks prior to first dose
- Palliative radiotherapy within 1 week or lung radiotherapy over 30 Gy within 6 months prior to first dose
- Major surgery or significant trauma within 4 weeks prior to first dose
- Participation in another clinical trial within 4 weeks prior to first dose except for specified exceptions
- Serious thrombotic or bleeding events within specified timeframes
- Pregnancy or breastfeeding
- Any other condition deemed inappropriate by investigators for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
Y
Yinghui Sun, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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