Status:
TERMINATED
A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Advanced Non-Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective of the study is to compare the objective response rate (ORR) of high dose cemiplimab (HDREGN2810) and standard dose cemiplimab plus ipilimumab combination therapy (SDREGN2810/ipi...
Eligibility Criteria
Inclusion
- Key
- Patients with histologically or cytologically documented squamous or non-squamous NSCLC who either have stage IIIb or stage IIIc disease who are not candidates for treatment with definitive concurrent chemo-radiation or have stage IV disease. Patients must have PD after receiving one prior line of chemotherapy treatment for advanced NSCLC.
- Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue biopsy sample
- Biopsy evaluable for expression of PD-L1 as determined by a PD-L1 Immunohistochemistry (IHC) pharma diagnostic test (pharmDx) assay performed by a central laboratory
- At least 1 radiographically measureable lesion by computed tomography (CT) per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- Key
Exclusion
- Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
- Active or untreated brain metastases or spinal cord compression
- Patients with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase (ROS1) fusions
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years
- Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest a risk of immunerelated treatment-emergent adverse events (irTEAEs)
- Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of randomization
- Note: Other protocol defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
May 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03430063
Start Date
May 29 2018
End Date
October 27 2021
Last Update
November 3 2022
Active Locations (31)
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1
Regeneron Research Site
Phoenix, Arizona, United States, 85054
2
Regeneron Research Site
Los Angeles, California, United States, 90033
3
Regeneron Research Site
Whittier, California, United States, 90603
4
Regeneron Research Site
Scarborough, Maine, United States, 04074