Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:57 AM
Study NCT ID:
NCT07362459
Status:
RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Tolerability of SCTB14 as First-Line Therapy in Non-Small Cell Lung Cancer.
Sponsor:
Sinocelltech Ltd.
Organization:
Study Overview
Official Title:
A Phase III, Randomized, Double-blind, Multicenter Clinical Study to Evaluate the Efficacy and Safety of SCTB14 Versus Pembrolizumab as First-Line Therapy in Patients With Driver Gene-Negative, TPS ≥10% Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2026-01
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:
This Phase III, randomized, double-blind study compares the efficacy and safety of SCTB14 versus pembrolizumab as first-line treatment in patients with driver gene-negative, TPS ≥10% locally advanced or metastatic non-small cell lung cancer (NSCLC). The primary objective is to assess superiority of SCTB14 over pembrolizumab in prolonging progression-free survival. Safety will be closely monitored.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: