Non-small Cell Lung Cancer
Conditions
Keywords
Stage IIIB, Stage IIIC, Stage IV, Non-squamous NSCLC, Squamous NSCLC
Brief summary
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.
Interventions
DRUGREGN2810
REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
OTHERChemotherapy
Platinum-based doublet chemotherapy Part 1
DRUGPlacebo
Matching placebo Part 2
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part 1: Open label Part 2: Double blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | Up to 32 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | Up to 32 months | — |
| Duration of Response (DOR) | Up to 32 months | — |
| Best overall response (BOR) | 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 | Part 1 only |
| Progression-free survival | Up to 32 months | — |
| Incidence of deaths | Up to 32 months | — |
| Incidence of laboratory abnormalities | Up to 32 months | — |
| Overall survival rate | 12 months | — |
| Quality of life as measured by EORTC QLQ-C30 | Up to 32 months | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) |
| Quality of life as measured by EORTC QLQ-LC13 | Up to 32 months | Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) |
| Incidence of serious adverse events (SAEs) | Up to 32 months | — |
Countries
Austria, China, France, Georgia, Greece, Ireland, Italy, Lithuania, Malaysia, Poland, Romania, Russia, Slovakia, South Korea, Thailand, Turkey (Türkiye), Ukraine, United States
Outcome results
None listed