Clinical trial NCT03430063: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Non-Small Cell Lung Carcinoma
Keywords: Advanced non-squamous NSCLC
Advanced squamous NSCLC
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2018-02-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Objective Response Rate (ORR) in Participants Whose Tumors Express Programmed Cell Death Ligand 1 (PD-L1) in <50% of Tumor Cells
timeFrame: From date of randomization up to 41 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: From date of randomization up to 41 months
measure: Overall Survival (OS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
timeFrame: Time from randomization to the date of death (up to 41 months)
measure: Progression Free Survival (PFS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
timeFrame: Time from randomization up to the date of the first documented tumor progression or death (up to 41 months)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death
timeFrame: Up to 41 months
measure: Number of Participants With Laboratory Test Abnormalities of Grade 2 or Higher Severity Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grading System
timeFrame: Up to 41 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Regeneron Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Regeneron Research Site
state: California
city: Whittier
country: United States
facility: Regeneron Research Site
state: California
city: Scarborough
country: United States
facility: Regeneron Research Site
state: Maine
city: Canton
country: United States
facility: Regeneron Research Site
state: Ohio
city: Massillon
country: United States
facility: Regeneron Research Site
state: Ohio
city: Herstal
country: Belgium
facility: Regeneron Research Site
city: Yvoir
country: Belgium
facility: Regeneron Research Site
city: Poitiers
country: France
facility: Regeneron Research Site
city: Rennes
country: France
facility: Regeneron Research Site
city: Saint-Mandé
country: France
facility: Regeneron Research Site
city: Gauting
country: Germany
facility: Regeneron Research Site
city: Incheon
country: Korea, Republic of
facility: Regeneron Research Site
city: Jeongnam
country: Korea, Republic of
facility: Regeneron Research Site
city: Seongnam
country: Korea, Republic of
facility: Regeneron Research Site
city: Seoul
country: Korea, Republic of
facility: Regeneron Research Site
city: Seoul
country: Korea, Republic of
facility: Regeneron Research Site
city: Seoul
country: Korea, Republic of
facility: Regeneron Research Site
city: Suwon
country: Korea, Republic of
facility: Regeneron Research Site
city: Gdynia
country: Poland
facility: Regeneron Research Site
city: Grudziądz
country: Poland
facility: Regeneron Research Site
city: Otwock
country: Poland
facility: Regeneron Research Site
city: Badalona
country: Spain
facility: Regeneron Research Site
city: Barcelona
country: Spain
facility: Regeneron Research Site
city: Madrid
country: Spain
facility: Regeneron Research Site
city: Málaga
country: Spain
facility: Regeneron Research Site
city: Zaragoza
country: Spain
facility: Regeneron Research Site
city: Taipei
country: Taiwan
facility: Regeneron Research Site
city: London
country: United Kingdom
facility: Regeneron Research Site
city: Manchester
country: United Kingdom
facility: Regeneron Research Site
city: Plymouth
country: United Kingdom
facility: Regeneron Research Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: