Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET … (NCT06031558) | Clinical Trial Compass
RecruitingPhase 3
Phase III Study of SY-5007, a RET Inhibitor, in Patients With Locally Advanced or Metastatic RET Fusion-positive NSCLC
China120 participantsStarted 2023-06-20
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female, at least 18 years old.
✓. Histologically or cytologically confirmed diagnosis of locally advanced (with a tumor lesion that cannot be eradicated by surgery or radiotherapy as assessed by the investigators) or metastatic NSCLC.
✓. No prior systemic antitumor therapy for locally advanced or metastatic NSCLC (Note: enrollment is permitted in the following 2 situations: 1) received only adjuvant therapy and the end of treatment was ≥ 6 months prior to the first dose; 2) received only radical radiotherapy and the end of treatment was ≥ 6 months prior to the first dose).
✓. The patient's tumor tissue or blood sample test result meets 1 of the following two criteria: a. Previous tumor tissue or blood samples are confirmed as RET fusion positive by local laboratory testing. b. If there is no previous RET fusion positive test report, a compliant tumor tissue or blood sample is required to be provided at the central laboratory, using a next-generation sequencing (NGS)-based assay to confirm RET fusion positive.
✓. Patients have at least one measurable lesion per RECIST version 1.1. (except for patients with measurable lesions in the brain only) (Note: a lesion that has been treated with radiotherapy or localized therapy is generally not considered a measurable lesion unless there is definitive progression of that lesion).
✓. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
✓. Life expectancy of at least 3 months.
✓. Patients must have adequate organ function as defined in the below:
Exclusion criteria
What they're measuring
1
Assessment of ORR by independent review committee (IRC).
Timeframe: Tumor scans performed at baseline then every 8 weeks up to 1 year, then every 12 weeks thereafter; up to 3 years.
. Patients carried known major driver genetic alterations other than RET. e.g. EGFR, MET, ALK, ROS1, NTRK, BRAF V600, KRAS G12C, etc. (If a patient has a co-mutation, discuss with the investigators whether enrollment is possible).
✕. History of allergy to any components or excipients of SY-5007 tablets.
✕. Patients with malignancies other than NSCLC treated in this study (except: malignancies that are cured and have not recurred within 2 years prior to study entry; completely resected basal cell and squamous cell skin cancer; completely resected carcinoma in situ of the cervix or breast).
✕. Patient has clinically symptomatic primary central nervous system (CNS) tumor, symptomatic CNS metastases, molluscum contagiosum, or untreated spinal cord compression; exclusion: patient has stable CNS disease (no evidence of progression as determined by imaging for at least 4 weeks prior to the first dose and all neurological symptoms have returned to baseline levels), no evidence of new or enlarging brain metastases, and has not had CNS surgery or radiotherapy within 4 weeks prior to the first dose, has not undergone stereotactic radiosurgery within 2 weeks, and has discontinued or stabilized steroid dosing within 2 weeks.
✕. Comorbidities of the following symptoms or conditions prior to the first dose that remain poorly controlled with optimal therapy:
✕. Presence of serious cardiovascular disease/abnormalities as indicated by any of the following:
✕. Presence of active viral infection or history of:
✕. Presence of other lung diseases that require systemic treatment or are serious, such as active tuberculosis, interstitial lung disease, etc., which in the opinion of the investigators may influence the interpretation of the study results or put the patient at high risk.