Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635824
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Trial to Evaluate Acasunlimab and Pembrolizumab Combination Superiority Over Standard of Care Docetaxel in Non-Small Cell Lung Cancer ABBIL1TY NSCLC-06
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Open-Label Randomized Phase 3 Trial of Acasunlimab GEN1046 in Combination With Pembrolizumab Versus Docetaxel in Subjects With PD-L1 Positive Metastatic Non-Small Cell Lung Cancer After Treatment With a PD-1PD-L1 Inhibitor and Platinum-Containing Chemotherapy ABBIL1TY NSCLC-06
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter randomized open-label international Phase 3 trial to evaluate the efficacy and safety of acasunlimab in combination with pembrolizumab versus docetaxel standard of care in participants with programmed death ligand 1 PD-L1-positive metastatic non-small cell lung cancer NSCLC who have been treated with programmed cell death protein 1 PD-1PD-L1 inhibitor and platinum-containing chemotherapy administered either in combination or sequentially in the metastatic setting
Detailed Description:
The goal of this trial is to determine the efficacy and safety of acasunlimab an experimental antibody also known as GEN1046 or DuoBody PDL1x4-1BB in combination with pembrolizumab an antibody known as KEYTRUDA compared to that of docetaxel a standard of care chemotherapy During the trial the participants quality of life will also be evaluated using industry-standard scales of measurement To be eligible participants
1 must have lung cancer that has metastasized spread
2 have tumors that are positive for the PD-L1 protein a biomarker that may be predictive of response to therapy
3 will have been previously treated with a PD-1PD-L1-inhibitor and a platinum-containing cancer therapy administered in combination or sequentially
Other eligibility criteria will also apply
Participants will be assigned to 1 of 2 active therapies also known as treatment arms as follows
Acasunlimab 100 mg and pembrolizumab 400 mg once every 6 weeks Q6W or
Docetaxel 75 mgm2 once every 3 weeks Q3W
The estimated trial duration for a participant will vary but may be up to 5 years consisting of
An optional 56-day pre-screening period
A 28-day screening period
Up to 2 years of treatment
A 90-day safety follow-up period
Post-treatment follow-up
1 must have lung cancer that has metastasized spread
2 have tumors that are positive for the PD-L1 protein a biomarker that may be predictive of response to therapy
3 will have been previously treated with a PD-1PD-L1-inhibitor and a platinum-containing cancer therapy administered in combination or sequentially
Other eligibility criteria will also apply
Participants will be assigned to 1 of 2 active therapies also known as treatment arms as follows
Acasunlimab 100 mg and pembrolizumab 400 mg once every 6 weeks Q6W or
Docetaxel 75 mgm2 once every 3 weeks Q3W
The estimated trial duration for a participant will vary but may be up to 5 years consisting of
An optional 56-day pre-screening period
A 28-day screening period
Up to 2 years of treatment
A 90-day safety follow-up period
Post-treatment follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None