Description:
The primary objectives of this study are:
Part 1: To compare the overall survival (OS) 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) with tumors expressing
PD-L1 in <50% of tumor cells.
Part 2: To compare the OS 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 objectives are:
Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of
cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of
patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in <50% of
tumor cells.
Part 2: To compare the PFS and 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.
Title
- Brief Title: Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer
- Official Title: A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
R2810-ONC-16113
- SECONDARY ID:
2017-001311-36
- NCT ID:
NCT03409614
Conditions
- Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
REGN2810 | cemiplimab | REGN2810+Chemo Part 1 |
REGN2810/chemo/ipi | cemiplimab | REGN2810+AbbrevChemo+ipi |
Placebo | | Chemo |
Purpose
The primary objectives of this study are:
Part 1: To compare the overall survival (OS) 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) with tumors expressing
PD-L1 in <50% of tumor cells.
Part 2: To compare the OS 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 objectives are:
Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of
cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of
patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in <50% of
tumor cells.
Part 2: To compare the PFS and 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.
Trial Arms
Name | Type | Description | Interventions |
---|
Chemo | Other | Part 1: Chemotherapy | |
REGN2810+Chemo Part 1 | Experimental | Part 1: REGN2810+chemo | |
REGN2810+AbbrevChemo+ipi | Experimental | Part 1: REGN2810+abbrev chemo+ipi | |
Placebo+Chemo | Experimental | Part 2: Placebo plus chemo | |
REGN2810+Chemo Part 2 | Experimental | Part 2: REGN2810+chemo | |
Eligibility Criteria
Key Inclusion Criteria:
1. Men and women ≥20 years of age for Japanese patients
2. Patients with histologically or cytologically documented squamous or non-squamous
NSCLC with stage IIIB or IIIC disease who are not candidates for treatment with
definitive concurrent chemoradiation or patients with stage IV disease if they have
not received prior systemic treatment for recurrent or metastatic NSCLC
3. Availability of an archival (≤5 months) or on-study obtained formalin-fixed,
paraffin-embedded tumor tissue sample from a metastatic or recurrent site, which has
not previously been irradiated
4. Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commercially
available assay performed by the central laboratory
5. At least 1 radiographically measurable 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
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
7. Anticipated life expectancy of at least 3 months
Key Exclusion Criteria:
1. Part 1 only: 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 enrollment
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. 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: | Overall survival |
Time Frame: | Up to 32 months |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Progression-free survival |
Time Frame: | Up to 32 months |
Safety Issue: | |
Description: | |
Measure: | Objective response rate |
Time Frame: | Up to 32 months |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) |
Time Frame: | Up to 32 months |
Safety Issue: | |
Description: | |
Measure: | Best overall response (BOR) |
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: | Part 1 only |
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 rate |
Time Frame: | 12 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival rate |
Time Frame: | 18 months |
Safety Issue: | |
Description: | |
Measure: | Overall survival rate |
Time Frame: | 24 months |
Safety Issue: | |
Description: | |
Measure: | Quality of life as measured by EORTC QLQ-C30 |
Time Frame: | Up to 32 months |
Safety Issue: | |
Description: | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) |
Measure: | Quality of life as measured by EORTC QLQ-LC13 |
Time Frame: | Up to 32 months |
Safety Issue: | |
Description: | Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Regeneron Pharmaceuticals |
Trial Keywords
- Stage IIIB
- Stage IIIC
- Stage IV
- Non-squamous NSCLC
- Squamous NSCLC
Last Updated
October 8, 2020