Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT06031558
Brief 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.
Detailed Description:
This study will enroll patients with locally advanced or metastatic RET-positive NSCLC. SY-5007 will be administered orally 160 mg twice daily in 28-day cycle continuously until disease progression, death, unacceptable toxicity, withdrawal of consent, or protocol-specified parameters. This study is designed to evaluate the anti-tumor activity (over response rate \[ORR\], disease control rate \[DCR\], duration of response \[DOR\], progression free survival \[PFS\] and overall survival \[OS\]) and safety of SY-5007 in patients.
Study:
NCT06031558
Study Brief:
Protocol Section:
NCT06031558