Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616584
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had Previous Treatment With Platinum Chemotherapy and Immunotherapy An Expanded Lung-MAP Treatment Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Phase IIIII Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer Lung-MAP Non-Matched Sub-Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 phase IIIII Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement recurrent Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway Tumors use the PD-1 pathway to escape attacks from the immune system By blocking the PD-1 pathway cemiplimab may help the immune system recognize and attack tumor cells Docetaxel is in a class of medications called taxanes It stops tumor cells from growing and dividing and may kill them Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow Adding cemiplimab to usual treatment docetaxel and ramucirumab may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer
Detailed Description:
PRIMARY OBJECTIVE
I To compare overall survival OS between participants randomized to docetaxel and ramucirumab with or without cemiplimab REGN2810 who have acquired resistance to platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To compare investigator-assessed progression-free survival PFS per Response Evaluation Criteria in Solid Tumors RECIST 11 between the arms
II To compare investigator-assessed response rates confirmed or unconfirmed complete response CR or partial response PR per RECIST 11 between the arms among participants with measurable disease
III To compare the investigator-assessed disease control rate confirmed or unconfirmed complete response CR or partial response PR and stable disease between the arms
IV To evaluate the duration of response DoR among responders within each arm
V To evaluate the frequency and severity of toxicities within each arm VI To compare investigator-assessed PFS between the arms within the subgroups defined by the stratification factors histology and performance status and by PD-L1 subgroups defined as PD-L1 negative 1 tumor proportion score TPS intermediate PD-L1 1-49 TPS and PD-L1 high 50 TPS
VII To compare OS between the arms within the subgroups defined by the stratification factors histology and performance status and by PD-L1 subgroups defined as PD-L1 negative 1 TPS intermediate PD-L1 1-49 TPS and PD-L1 high 50 TPS
TRANSLATIONAL MEDICINE OBJECTIVES
I To collect process and bank cell-free deoxyribonucleic acid cfDNA at baseline cycle 3 day 1 and progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA ctDNA
II To establish a tissueblood repository to pursue future studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive dexamethasone orally PO twice daily BID on days 0-2 ramucirumab intravenously IV over 30-60 minutes on day 1 and docetaxel IV over 60 minutes on day 1 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection and computed tomography CT or magnetic resonance imaging MRI throughout the study
ARM II Patients receive dexamethasone PO BID on days 0-2 ramucirumab IV over 30-60 minutes on day 1 docetaxel IV over 60 minutes on day 1 and cemiplimab IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection and CT or MRI throughout the study
After completion of study treatment patients are followed up every 3-6 months for up to 3 years after randomization
I To compare overall survival OS between participants randomized to docetaxel and ramucirumab with or without cemiplimab REGN2810 who have acquired resistance to platinum-based chemotherapy and immunotherapy for stage IV or recurrent non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To compare investigator-assessed progression-free survival PFS per Response Evaluation Criteria in Solid Tumors RECIST 11 between the arms
II To compare investigator-assessed response rates confirmed or unconfirmed complete response CR or partial response PR per RECIST 11 between the arms among participants with measurable disease
III To compare the investigator-assessed disease control rate confirmed or unconfirmed complete response CR or partial response PR and stable disease between the arms
IV To evaluate the duration of response DoR among responders within each arm
V To evaluate the frequency and severity of toxicities within each arm VI To compare investigator-assessed PFS between the arms within the subgroups defined by the stratification factors histology and performance status and by PD-L1 subgroups defined as PD-L1 negative 1 tumor proportion score TPS intermediate PD-L1 1-49 TPS and PD-L1 high 50 TPS
VII To compare OS between the arms within the subgroups defined by the stratification factors histology and performance status and by PD-L1 subgroups defined as PD-L1 negative 1 TPS intermediate PD-L1 1-49 TPS and PD-L1 high 50 TPS
TRANSLATIONAL MEDICINE OBJECTIVES
I To collect process and bank cell-free deoxyribonucleic acid cfDNA at baseline cycle 3 day 1 and progression for future development of a proposal to evaluate comprehensive next-generation sequencing of circulating tumor DNA ctDNA
II To establish a tissueblood repository to pursue future studies
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive dexamethasone orally PO twice daily BID on days 0-2 ramucirumab intravenously IV over 30-60 minutes on day 1 and docetaxel IV over 60 minutes on day 1 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection and computed tomography CT or magnetic resonance imaging MRI throughout the study
ARM II Patients receive dexamethasone PO BID on days 0-2 ramucirumab IV over 30-60 minutes on day 1 docetaxel IV over 60 minutes on day 1 and cemiplimab IV over 30 minutes on day 1 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Additionally patients undergo blood sample collection and CT or MRI throughout the study
After completion of study treatment patients are followed up every 3-6 months for up to 3 years after randomization
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