Clinical Trials /

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

NCT03409614

Description:

The primary objectives of this study are: Part 1: To evaluate the objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) in the subgroup of patients whose tumors express programmed cell death ligand-1 (PD-L1) in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells. Part 2: To compare the overall survival (OS) and progression-free survival (PFS) of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression. The key secondary objective is: Part 2: To compare the ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

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

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
  • Official Title: A Randomized, Phase 3, Open-label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer With Tumors Expressing PD-L1 <50%

Clinical Trial IDs

  • ORG STUDY ID: R2810-ONC-16113
  • SECONDARY ID: 2017-001311-36
  • NCT ID: NCT03409614

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
REGN2810Dose 1
REGN2810/chemo/ipiDose 2

Purpose

The primary objective is to compare the progression-free survival (PFS) of REGN2810 plus platinum-based doublet chemotherapy combination therapy (REGN2810/chemo) and REGN2810 plus platinum-based doublet chemotherapy plus ipilimumab combination therapy (REGN2810/chemo/ipi) with standard-of-care platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) in the subgroup of patients whose tumors express programmed cell death ligand 1 (PD-L1) in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells. The key secondary objectives are to compare the OS of REGN2810/chemo and REGN2810/chemo/ipi versus standard-of-care platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC in the subgroup of patients whose tumors express PD-L1 in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells, to compare the ORR of REGN2810/chemo and REGN2810/chemo/ipi versus standard-of-care platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC in the subgroup of patients whose tumors express PD-L1 in 1% to <50% of tumor cells and in the overall population of study patients whose tumors express PD-L1 in <50% of tumor cells, and to evaluate the safety and tolerability of REGN2810/chemo and REGN2810/chemo/ipi compared to standard-of-care platinum-based doublet chemotherapy

Trial Arms

NameTypeDescriptionInterventions
Standard-of-Care (SOC)OtherChemotherapy
    Dose 1ExperimentalREGN2810/chemo
    • REGN2810
    Dose 2ExperimentalDrug: REGN2810/abbrev chemo/ipi
    • REGN2810/chemo/ipi

    Eligibility Criteria

            Key Inclusion Criteria:
    
              1. Patients with histologically or cytologically documented squamous or non-squamous
                 NSCLC with stage IIIB or stage IV disease, who received no prior systemic treatment
                 for recurrent or metastatic NSCLC
    
              2. Availability of an archival (≤5 months) or on-study obtained formalin-fixed,
                 paraffin-embedded tumor tissue sample from a metastatic/recurrent site, which has not
                 previously been irradiated
    
              3. Expression of PD-L1 in <50% of tumor cells determined by the commercially available
                 assay performed by the central laboratory
    
              4. At least 1 radiographically measureable lesion by computed tomography (CT) or magnetic
                 resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a
                 previously irradiated field if there is documented (radiographic) disease progression
                 in that site
    
              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), of 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 risk of immune-related
                 treatment-emergent adverse events (irTEAEs)
    
              7. Previous treatment with idelalisib at any time (ZYDELIG®)
    
              8. 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:PFS as assessed by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessments
    Time Frame:Up to 32 months
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:Overall survival (OS)
    Time Frame:Up to 32 months
    Safety Issue:
    Description:
    Measure:Objective response rate (ORR)
    Time Frame:Up to 32 months
    Safety Issue:
    Description:
    Measure:Incidence of Treatment-emergent adverse events (TEAEs)
    Time Frame:Up to 32 months
    Safety Issue:
    Description:
    Measure:Incidence of Dose-limiting toxicities (DLTs)
    Time Frame:Up to 32 months
    Safety Issue:
    Description:
    Measure:Incidence of serious adverse events (SAEs)
    Time Frame:Up to 32 months
    Safety Issue:
    Description:
    Measure:Incidence of deaths
    Time Frame:Up to 32 months
    Safety Issue:
    Description:
    Measure:Incidence of laboratory abnormalities
    Time Frame:Up to 32 months
    Safety Issue:
    Description:
    Measure:Overall survival
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:Overall survival
    Time Frame:18 months
    Safety Issue:
    Description:
    Measure:Quality of life
    Time Frame:Up to 32 months
    Safety Issue:
    Description:As measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
    Measure:Quality of life
    Time Frame:Up to 32 months
    Safety Issue:
    Description:As measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

    Details

    Phase:Phase 3
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Regeneron Pharmaceuticals

    Trial Keywords

    • Stage IIIB
    • Stage IV
    • Non-squamous NSCLC
    • Squamous NSCLC

    Last Updated

    March 22, 2018