Lung Cancer Clinical Trial
A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
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) to the ORR of standard dose cemiplimab (SDREGN2810) in the second-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC), in patients whose tumors express programmed cell death ligand 1 (PD-L1) in <50% of tumor cells.
Eligibility Criteria
Key Inclusion Criteria:
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 Criteria:
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.
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There are 31 Locations for this study
Phoenix Arizona, 85054, United States
Los Angeles California, 90033, United States
Whittier California, 90603, United States
Scarborough Maine, 04074, United States
Canton Ohio, 44708, United States
Massillon Ohio, 44646, United States
Herstal , 4040, Belgium
Yvoir , 5530, Belgium
Poitiers , 86021, France
Rennes , 35033, France
Saint-Mandé , 94160, France
Gauting , 82131, Germany
Incheon , 22332, Korea, Republic of
Jeongnam , 58128, Korea, Republic of
Seongnam , 46370, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06591, Korea, Republic of
Suwon , 16247, Korea, Republic of
Gdynia , 81519, Poland
GrudziÄ…dz , 86300, Poland
Otwock , 05400, Poland
Badalona , 8911, Spain
Barcelona , 08025, Spain
Madrid , 28046, Spain
Málaga , 29010, Spain
Zaragoza , 50009, Spain
Taipei , 11217, Taiwan
London , W1G6A, United Kingdom
Manchester , M20 4, United Kingdom
Plymouth , PL68D, United Kingdom
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