Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322108
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-02-28
Brief Title:
Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer IMMONC0008
Sponsor:
Immune Oncology Research Institute
Organization:
Immune Oncology Research Institute
Study Overview
Official Title:
Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer IMMONC0008
Status:
RECRUITING
Status Verified Date:
2024-05
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 goal of this study is to see if the combination of immunotherapy agents botensilimab and balstilimab is safe and effective in participants with metastatic non-small cell lung cancer NSCLC as a first-line treatment
Detailed Description:
This is a single-arm open-label phase II study to evaluate the safety and efficacy of the combination of botensilimab and balstilimab in participants with metastatic non-small cell lung cancer NSCLC The study will enroll participants with a histologically confirmed diagnosis of metastatic NSCLC and without targetable EGFR mutation or ALK rearrangement while excluding those with untreated brain metastases or oligometastatic disease lacking targetable lesions
The total estimated maximum time of study participation for each patient is approximately 49 months across 3 periods
Screening Period approximately 28 days
Treatment Period up to 24 months or until any criterion for stopping the study drug or withdrawal from the study occurs
Follow-up Period up to 24 months from last dose of study treatment for every patient who is alive
Study Duration
Recruitment 2 years
Treatment 2 years
Follow-up 2 years
The total estimated maximum time of study participation for each patient is approximately 49 months across 3 periods
Screening Period approximately 28 days
Treatment Period up to 24 months or until any criterion for stopping the study drug or withdrawal from the study occurs
Follow-up Period up to 24 months from last dose of study treatment for every patient who is alive
Study Duration
Recruitment 2 years
Treatment 2 years
Follow-up 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None