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.
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
Drug | Synonyms | Arms |
---|
REGN2810/ipi | cemiplimab | REGN2810/ipi |
REGN2810/chemo/ipi | cemiplimab | REGN2810/chemo/ipi |
Pembrolizumab | | Pembrolizumab |
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
Name | Type | Description | Interventions |
---|
Pembrolizumab | Active Comparator | Pembrolizumab | |
REGN2810/ipi | Experimental | REGN2810/ipi | |
REGN2810/chemo/ipi | Experimental | 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: | Completed |
Lead Sponsor: | Regeneron Pharmaceuticals |
Trial Keywords
- Stage IIIB
- Stage IV
- Non-squamous NSCLC
- Squamous NSCLC
Last Updated
August 13, 2021