TerminatedPhase 2NCT03430063

A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

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.

Checked against the public recordLast updated Nov 3, 2022 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations31
SponsorRegeneron Pharmaceuticals
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Regeneron Pharmaceuticals
Interventions being studied
Drug: SDREGN2810; Drug: SDREGN2810/ipi; Drug: HDREGN2810
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Key Inclusion Criteria: 1. 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. 2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue biopsy sample 3. 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 4. At least 1 radiographically measureable lesion by computed tomography (CT) per RECIST 1.1 criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 Key Exclusion Criteria: 1. Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime 2. Active or untreated brain metastases or spinal cord compression 3. 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 4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization 5. 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 6. 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) 7. 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Regeneron Research SitePhoenix, Arizona
  • Regeneron Research SiteLos Angeles, California
  • Regeneron Research SiteWhittier, California
  • Regeneron Research SiteScarborough, Maine
  • Regeneron Research SiteCanton, Ohio
  • Regeneron Research SiteMassillon, Ohio
  • Regeneron Research SiteHerstal
  • Regeneron Research SiteYvoir
  • Regeneron Research SitePoitiers
  • Regeneron Research SiteRennes
  • Regeneron Research SiteSaint-Mandé
  • Regeneron Research SiteGauting

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 3, 2022. Always confirm current availability with the study team.

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