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.
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 Advanced Non-Small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
R2810-ONC-1763
- SECONDARY ID:
2017-003684-35
- NCT ID:
NCT03430063
Conditions
- Advanced Non-Small Cell Lung Carcinoma
Interventions
Drug | Synonyms | Arms |
---|
SDREGN2810 | REGN2810, cemiplimab | SDREGN2810 |
SDREGN2810/ipi | REGN2810, cemiplimab, ipilimumab | SDREGN2810/ipi |
HDREGN2810 | REGN2810, cemiplimab | HDREGN2810 |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
SDREGN2810 | Experimental | | |
SDREGN2810/ipi | Experimental | | |
HDREGN2810 | Experimental | | |
Eligibility Criteria
Key Inclusion Criteria:
1. Patients with histologically or cytologically documented squamous or non-squamous
NSCLC who either have stage IIIb or stage IIIc disease who are not candidates for
treatment with definitive concurrent chemo-radiation or have stage IV disease.
Patients must have PD after receiving one prior line of chemotherapy treatment for
advanced NSCLC.
2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded
tumor tissue biopsy sample
3. Biopsy evaluable for expression of PD-L1 as 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
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 randomization
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 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) in patients whose tumors express PD-L1 in <50% of tumor cells |
Secondary Outcome Measures
Measure: | ORR in all patients |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) in patients whose tumors express PD-L1 in <50% of tumor cells |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Measure: | OS in all patients |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Measure: | Progression free survival (PFS) in patients whose tumors express PD-L1 in <50% of tumor cells |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Measure: | PFS in all patients |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Measure: | Incidences 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: | Incidences of serious adverse events (SAEs) as assessed by the NCI-CTCAE grading system |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Measure: | Incidences of deaths |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Measure: | Incidences of laboratory abnormalities as assessed by the NCI-CTCAE grading system |
Time Frame: | Up to 31 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Regeneron Pharmaceuticals |
Trial Keywords
- Advanced non-squamous NSCLC
- Advanced squamous NSCLC
Last Updated
August 25, 2021