Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06254599
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2024-02-01
Brief Title:
A Study Of SY-3505 Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC
Sponsor:
Shouyao Holdings Beijing Co LTD
Organization:
Shouyao Holdings Beijing Co LTD
Study Overview
Official Title:
A Phase III Study to Evaluate and Compare the Efficacy and Safety of SY-3505 Versus Crizotinib in Treatment-Naive Patients With Anaplastic Lymphoma Kinase ALK-Positive Advanced Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A phase 3 study to evaluate the efficacy and safety of SY-3505 vs crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy
Detailed Description:
This is a multicenter randomized controlled phase III trial to evaluate the efficacy and safety of SY-3505 capsule vs crizotinib capsule in treatment-naive patients with ALK-positive NSCLC
Participants will be randomized in a 21 ratio to receive SY-3505 600 milligrams mg orally once daily QD or crizotinib 250 mg orally twice daily BID Participants will receive treatment until disease progression unacceptable toxicity withdrawal of consent or death
Participants will be randomized in a 21 ratio to receive SY-3505 600 milligrams mg orally once daily QD or crizotinib 250 mg orally twice daily BID Participants will receive treatment until disease progression unacceptable toxicity withdrawal of consent or death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None