REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pembrolizumab Pembrolizumab |
Drug: Pembrolizumab
Reference drug administered IV infusion
|
| Experimental: REGN2810/ipi REGN2810/ipi |
Drug: REGN2810/ipi
REGN2810 plus ipilimumab
Other Names:
|
| Experimental: REGN2810/chemo/ipi REGN2810/chemo/ipi |
Drug: REGN2810/chemo/ipi
REGN2810 plus chemotherapy plus Ipilimumab
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 [Up to 32 months]
Secondary Outcome Measures
- Overall survival (OS) [Up to 32 months]
- Objective response rate (ORR) [Up to 32 months]
- Incidence of Treatment-emergent adverse events (TEAEs) [Up to 32 months]
- Incidence of Dose-limiting toxicities (DLTs) [Up to 32 months]
- Incidence of serious adverse events (SAEs) [Up to 32 months]
- Incidence of deaths [Up to 32 months]
- Incidence of laboratory abnormalities [Up to 32 months]
- Overall survival [12 months]
- Overall survival [18 months]
- Quality of life (Core 30 Questionnaire) [Up to 32 months]
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"
- Quality of life (Lung Cancer 13 Questionnaire) [Up to 32 months]
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".
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
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
-
Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample which has not previously been irradiated
-
Expression of PD-L1 in ≥50% of tumor cells determined by the commercially available assay performed by the central laboratory
-
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
-
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
-
Anticipated life expectancy of at least 3 months
Key Exclusion Criteria:
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Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
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Active or untreated brain metastases or spinal cord compression
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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
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Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
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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
-
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)
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Previous treatment with idelalisib at any time (ZYDELIG®)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Regeneron Research Site | Saint Petersburg | Florida | United States | 33709 |
| 2 | Regeneron Research Site | Cremona | Italy | 26100 | |
| 3 | Regeneron Research Site | Vilnius | Lithuania | 08660 |
Sponsors and Collaborators
- Regeneron Pharmaceuticals
- Sanofi
Investigators
- Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R2810-ONC-16111
- 2017-001041-27