Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690945
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-19
First Post:
2023-01-10
Brief Title:
A Study of QL1706 in Combination With Chemotherapy in PD-L1-Negative Non-small Cell Lung Cancer
Sponsor:
Qilu Pharmaceutical Co Ltd
Organization:
Qilu Pharmaceutical Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Multicenter Phase 3 Clinical Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Chemotherapy in First-line PD-L1 Negative Locally Advanced or Metastatic Non-small Cell Lung Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
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:
The purpose of this study is to evaluate the efficacy and safety of QL1706 combined with platinum-based chemotherapy versus tislelizumab combined with platinum-based chemotherapy in PD-L1 negative locally advanced or metastatic Non-small Cell Lung Cancer Patients The subjects were randomly divided into two groups according to 11 with about 325 subjects in the experimental group and the control group
Detailed Description:
This study was a randomized double-blind active-controlled multicenter Phase 3 clinical study The study is designed to evaluate the efficacy and safety of QL1706 in combination with chemotherapy or commercial PD1 in combination with chemotherapy in locally advanced or metastatic NSCLC patients who are PD-L1 negative650 patients would be enrolled Subjects will be assigned randomly in a 11 ratio to experimental group and control group Subjects will be stratified by pathological type squamous cell carcinoma versus non-squamous cell carcinoma brain metastasis present versus absent gender male versus female After randomization subjects will be treated according to the randomization results
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