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 Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 <50%

Clinical Trial IDs

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

Conditions

  • Metastatic 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 REGN2810 (HDREGN2810) and standard dose REGN2810 plus ipilimumab combination therapy (SDREGN2810/ipi) versus standard dose REGN2810 (SDREGN2810) in the second-line treatment of patients with advanced or metastatic 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 3b disease and are not candidates for definitive
             concurrent chemo-radiation or have stage 4 disease. Patients must be immunotherapy
             naive and must have received one prior cytotoxic regimen.

          2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded
             tumor tissue biopsy sample

          3. Expression of PD-L1 in <50% of tumor cells 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

          6. Anticipated life expectancy of at least 3 months

        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 informed
             consent

          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 may 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)

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Progression free survival (PFS)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Incidence 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:Incidence of serious adverse events (SAEs) as assessed by the NCI-CTCAE grading system
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Incidence of deaths
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities as assessed by the NCI-CTCAE grading system
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Assessment of immunogenicity as measured by anti-drug antibody (ADA) titers for REGN2810
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Assessment of hair pigmentation
Time Frame:Up to 31 months
Safety Issue:
Description:As determined by investigator assessment
Measure:Tumor mutation burden as assessed by the Foundation Medicine "FoundationOne®" panel
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Assessment of tumor volume
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Inducible co-stimulatory positive (ICOS+) cluster of differentiation 4 (CD4) T-cell frequency and other markers of T-cell activation
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:Pharmacokinetics(PK): Concentration at end of infusion (Ceoi)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:PK: Preinfusion concentration (Ctrough)
Time Frame:Up to 31 months
Safety Issue:
Description:
Measure:PK: Time of end of infusion (teoi)
Time Frame:Up to 31 months
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Trial Keywords

  • Advanced non-squamous NSCLC
  • Advanced squamous NSCLC
  • Metastatic non-squamous NSCLC
  • Metastatic squamous NSCLC

Last Updated

April 27, 2018