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.

View Eligibility Criteria

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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

28

Study ID:

NCT03430063

Recruitment Status:

Terminated

Sponsor:

Regeneron Pharmaceuticals

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There are 31 Locations for this study

See Locations Near You

Regeneron Research Site
Phoenix Arizona, 85054, United States
Regeneron Research Site
Los Angeles California, 90033, United States
Regeneron Research Site
Whittier California, 90603, United States
Regeneron Research Site
Scarborough Maine, 04074, United States
Regeneron Research Site
Canton Ohio, 44708, United States
Regeneron Research Site
Massillon Ohio, 44646, United States
Regeneron Research Site
Herstal , 4040, Belgium
Regeneron Research Site
Yvoir , 5530, Belgium
Regeneron Research Site
Poitiers , 86021, France
Regeneron Research Site
Rennes , 35033, France
Regeneron Research Site
Saint-Mandé , 94160, France
Regeneron Research Site
Gauting , 82131, Germany
Regeneron Research Site
Incheon , 22332, Korea, Republic of
Regeneron Research Site
Jeongnam , 58128, Korea, Republic of
Regeneron Research Site
Seongnam , 46370, Korea, Republic of
Regeneron Research Site
Seoul , 03722, Korea, Republic of
Regeneron Research Site
Seoul , 05505, Korea, Republic of
Regeneron Research Site
Seoul , 06591, Korea, Republic of
Regeneron Research Site
Suwon , 16247, Korea, Republic of
Regeneron Research Site
Gdynia , 81519, Poland
Regeneron Research Site
Grudziądz , 86300, Poland
Regeneron Research Site
Otwock , 05400, Poland
Regeneron Research Site
Badalona , 8911, Spain
Regeneron Research Site
Barcelona , 08025, Spain
Regeneron Research Site
Madrid , 28046, Spain
Regeneron Research Site
Málaga , 29010, Spain
Regeneron Research Site
Zaragoza , 50009, Spain
Regeneron Research Site
Taipei , 11217, Taiwan
Regeneron Research Site
London , W1G6A, United Kingdom
Regeneron Research Site
Manchester , M20 4, United Kingdom
Regeneron Research Site
Plymouth , PL68D, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

28

Study ID:

NCT03430063

Recruitment Status:

Terminated

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

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