Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03430063
Registration number
NCT03430063
Ethics application status
Date submitted
29/01/2018
Date registered
12/02/2018
Date last updated
3/11/2022
Titles & IDs
Public title
A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
2017-003684-35
Query!
Secondary ID [2]
0
0
R2810-ONC-1763
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Advanced Non-Small Cell Lung Carcinoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - SDREGN2810
Treatment: Drugs - SDREGN2810/ipi
Treatment: Drugs - HDREGN2810
Experimental: SDREGN2810 -
Experimental: SDREGN2810/ipi -
Experimental: HDREGN2810 -
Treatment: Drugs: SDREGN2810
Standard dose intravenous (IV) infusion
Treatment: Drugs: SDREGN2810/ipi
Combination therapy dose IV
Treatment: Drugs: HDREGN2810
High dose IV
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Objective Response Rate (ORR) in Participants Whose Tumors Express Programmed Cell Death Ligand 1 (PD-L1) in <50% of Tumor Cells
Query!
Assessment method [1]
0
0
ORR was defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever came first. CR was defined as the disappearance of all target lesions (Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm [<1 cm]). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Query!
Timepoint [1]
0
0
From date of randomization up to 41 months
Query!
Secondary outcome [1]
0
0
Overall Response Rate
Query!
Assessment method [1]
0
0
Overall Response Rate was defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of participants in the efficacy analysis set. BOR was defined as the best response recorded, as determined by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) between the date of randomization and the date of the first objectively documented progression or the date of subsequent anti-cancer therapy, whichever came first. CR was defined as the disappearance of all target lesions (Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm [<1 cm]). PR was defined as having at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Query!
Timepoint [1]
0
0
From date of randomization up to 41 months
Query!
Secondary outcome [2]
0
0
Overall Survival (OS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
Query!
Assessment method [2]
0
0
OS was defined as the time from randomization to the date of death due to any cause. A participant who lost to follow-up was censored at the last date that the participant was known to be alive. OS was measured using Kaplan-Meier method.
Query!
Timepoint [2]
0
0
Time from randomization to the date of death (up to 41 months)
Query!
Secondary outcome [3]
0
0
Progression Free Survival (PFS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
Query!
Assessment method [3]
0
0
PFS was defined as the time from randomization to the date of the first documented tumor progression, as determined by the IRC (based on RECIST 1.1 assessments) or death due to any cause, whichever occurred earlier. PFS was measured using Kaplan-Meier method.
Query!
Timepoint [3]
0
0
Time from randomization up to the date of the first documented tumor progression or death (up to 41 months)
Query!
Secondary outcome [4]
0
0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death
Query!
Assessment method [4]
0
0
Adverse event (AE): any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs. Number of participants with TEAEs, Serious TEAEs and TEAEs leading to death were reported.
Query!
Timepoint [4]
0
0
Up to 41 months
Query!
Secondary outcome [5]
0
0
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
Query!
Assessment method [5]
0
0
The laboratory measurements included hematology, chemistry, electrolytes and liver function. NCI-CTCAE was graded according to the following scale: Grade 1 (Mild): Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 (Moderate): Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3 (Severe): Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL; Grade 4 (Life-threatening): Life-threatening consequences; urgent intervention indicated; Grade 5 (Death): Death related to AE.
Query!
Timepoint [5]
0
0
Up to 41 months
Query!
Eligibility
Key inclusion criteria
Key
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
29/05/2018
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
27/10/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
28
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Maine
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Ohio
Query!
Country [5]
0
0
Belgium
Query!
State/province [5]
0
0
Herstal
Query!
Country [6]
0
0
Belgium
Query!
State/province [6]
0
0
Yvoir
Query!
Country [7]
0
0
France
Query!
State/province [7]
0
0
Poitiers
Query!
Country [8]
0
0
France
Query!
State/province [8]
0
0
Rennes
Query!
Country [9]
0
0
France
Query!
State/province [9]
0
0
Saint-Mandé
Query!
Country [10]
0
0
Germany
Query!
State/province [10]
0
0
Gauting
Query!
Country [11]
0
0
Korea, Republic of
Query!
State/province [11]
0
0
Incheon
Query!
Country [12]
0
0
Korea, Republic of
Query!
State/province [12]
0
0
Jeongnam
Query!
Country [13]
0
0
Korea, Republic of
Query!
State/province [13]
0
0
Seongnam
Query!
Country [14]
0
0
Korea, Republic of
Query!
State/province [14]
0
0
Seoul
Query!
Country [15]
0
0
Korea, Republic of
Query!
State/province [15]
0
0
Suwon
Query!
Country [16]
0
0
Poland
Query!
State/province [16]
0
0
Gdynia
Query!
Country [17]
0
0
Poland
Query!
State/province [17]
0
0
Grudziadz
Query!
Country [18]
0
0
Poland
Query!
State/province [18]
0
0
Otwock
Query!
Country [19]
0
0
Spain
Query!
State/province [19]
0
0
Badalona
Query!
Country [20]
0
0
Spain
Query!
State/province [20]
0
0
Barcelona
Query!
Country [21]
0
0
Spain
Query!
State/province [21]
0
0
Madrid
Query!
Country [22]
0
0
Spain
Query!
State/province [22]
0
0
Málaga
Query!
Country [23]
0
0
Spain
Query!
State/province [23]
0
0
Zaragoza
Query!
Country [24]
0
0
Taiwan
Query!
State/province [24]
0
0
Taipei
Query!
Country [25]
0
0
United Kingdom
Query!
State/province [25]
0
0
London
Query!
Country [26]
0
0
United Kingdom
Query!
State/province [26]
0
0
Manchester
Query!
Country [27]
0
0
United Kingdom
Query!
State/province [27]
0
0
Plymouth
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Regeneron Pharmaceuticals
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Sanofi
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03430063
Query!
Trial related presentations / publications
Query!
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trial Management
Query!
Address
0
0
Regeneron Pharmaceuticals
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03430063
Download to PDF