Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472245
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-07
Brief Title:
Trial of Therapeutic Cancer Vaccine OSE2101 in Patients With Non-Small Cell Lung Cancer and Secondary Resistance to Immune Checkpoint Inhibitor
Sponsor:
OSE Immunotherapeutics
Organization:
OSE Immunotherapeutics
Study Overview
Official Title:
A Randomised Open-label Phase 3 Trial Comparing the Efficacy and Safety of OSE2101 Versus Docetaxel in HLA-A2 Positive Patients With Metastatic Non-Small Cell Lung Cancer NSCLC With Secondary Resistance to Immune Checkpoint Inhibitor
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
ARTEMIA
Brief Summary:
Multicenter randomized 21 open-label phase 3 study in HLA-A2 positive patients with squamous and non-squamous metastatic NSCLC with ICI secondary resistance
Patients will be randomized into 2 arms randomization 21 experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy Stratification factors will be histology squamous versus non squamous and ECOG Performance Status 0 versus 1
Patients will be randomized into 2 arms randomization 21 experimental Arm A with OSE2101 monotherapy or control Arm B SoC with docetaxel monotherapy Stratification factors will be histology squamous versus non squamous and ECOG Performance Status 0 versus 1
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None