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REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer

NCT03515629

Description:

The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as "REGN2810/chemo/ipi") with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.

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

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer
  • Official Title: A Randomized, Phase 3, Open-Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy 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-16111
  • SECONDARY ID: 2017-001041-27
  • NCT ID: NCT03515629

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
REGN2810/ipicemiplimabREGN2810/ipi
REGN2810/chemo/ipicemiplimabREGN2810/chemo/ipi
PembrolizumabPembrolizumab

Purpose

The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as "REGN2810/chemo/ipi") with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.

Trial Arms

NameTypeDescriptionInterventions
PembrolizumabActive ComparatorPembrolizumab
  • Pembrolizumab
REGN2810/ipiExperimentalREGN2810/ipi
  • REGN2810/ipi
REGN2810/chemo/ipiExperimentalREGN2810/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 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 (Core 30 Questionnaire)
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) four-point scale, with 1 as "not at all" and 4 as "very much"
Measure:Quality of life (Lung Cancer 13 Questionnaire)
Time Frame:Up to 32 months
Safety Issue:
Description:As measured by the Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) to assess lung cancer-associated symptoms and treatment-related side effects among lung cancer patients. The scale for EORTC-QLQ-LC13 is 1-4 for most outcome measures of systems, with 1 rated as "not at all" and 4 rated as "very much".

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

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