Clinical Trials /

A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

NCT03430063

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
  • Official Title: A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: R2810-ONC-1763
  • SECONDARY ID: 2017-003684-35
  • NCT ID: NCT03430063

Conditions

  • Advanced Non-Small Cell Lung Carcinoma

Interventions

DrugSynonymsArms
SDREGN2810REGN2810, cemiplimabSDREGN2810
SDREGN2810/ipiREGN2810, cemiplimab, ipilimumabSDREGN2810/ipi
HDREGN2810REGN2810, cemiplimabHDREGN2810

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
SDREGN2810Experimental
  • SDREGN2810
SDREGN2810/ipiExperimental
  • SDREGN2810/ipi
HDREGN2810Experimental
  • HDREGN2810

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:ORR
Time Frame:Up to 31 months
Safety Issue:
Description:Proportion of patients achieving complete response (CR) or partial response (PR) as assessed by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in patients whose tumors express PD-L1 in <50% of tumor cells

Secondary Outcome Measures

Measure:ORR in all patients
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Overall survival (OS) in patients whose tumors express PD-L1 in <50% of tumor cells
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:OS in all patients
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Progression free survival (PFS) in patients whose tumors express PD-L1 in <50% of tumor cells
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:PFS in all patients
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Incidences of treatment emergent adverse events (TEAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Incidences of serious adverse events (SAEs) as assessed by the NCI-CTCAE grading system
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Incidences of deaths
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Incidences of laboratory abnormalities as assessed by the NCI-CTCAE grading system
Time Frame:Up to 31 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Trial Keywords

  • Advanced non-squamous NSCLC
  • Advanced squamous NSCLC

Last Updated

August 25, 2021