Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06616584

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)

A Randomized Phase II/III 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
Recruiting
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
378 (estimated)
Sponsor
SWOG Cancer Research Network · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II/III 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) 1.1 between the arms. II. To compare investigator-assessed response rates (confirmed or unconfirmed, complete response \[CR\] or partial response \[PR\]) per RECIST 1.1 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 tissue/blood 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREBiospecimen CollectionUndergo blood sample collection
BIOLOGICALCemiplimabGiven IV
PROCEDUREComputed TomographyUndergo CT
DRUGDexamethasoneGiven PO
DRUGDocetaxelGiven IV
PROCEDUREMagnetic Resonance ImagingUndergo MRI
BIOLOGICALRamucirumabGiven IV

Timeline

Start date
2025-05-22
Primary completion
2027-12-31
Completion
2028-12-31
First posted
2024-09-27
Last updated
2026-01-23

Locations

361 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT06616584. Inclusion in this directory is not an endorsement.