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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2017-003684-35
Secondary ID [2] 0 0
R2810-ONC-1763
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Non-Small Cell Lung Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
From date of randomization up to 41 months
Secondary outcome [1] 0 0
Overall Response Rate
Timepoint [1] 0 0
From date of randomization up to 41 months
Secondary outcome [2] 0 0
Overall Survival (OS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
Timepoint [2] 0 0
Time from randomization to the date of death (up to 41 months)
Secondary outcome [3] 0 0
Progression Free Survival (PFS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
Timepoint [3] 0 0
Time from randomization up to the date of the first documented tumor progression or death (up to 41 months)
Secondary outcome [4] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death
Timepoint [4] 0 0
Up to 41 months
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
Timepoint [5] 0 0
Up to 41 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/10/2021
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Maine
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
Belgium
State/province [5] 0 0
Herstal
Country [6] 0 0
Belgium
State/province [6] 0 0
Yvoir
Country [7] 0 0
France
State/province [7] 0 0
Poitiers
Country [8] 0 0
France
State/province [8] 0 0
Rennes
Country [9] 0 0
France
State/province [9] 0 0
Saint-Mandé
Country [10] 0 0
Germany
State/province [10] 0 0
Gauting
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Incheon
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Jeongnam
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seongnam
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Seoul
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Suwon
Country [16] 0 0
Poland
State/province [16] 0 0
Gdynia
Country [17] 0 0
Poland
State/province [17] 0 0
Grudziadz
Country [18] 0 0
Poland
State/province [18] 0 0
Otwock
Country [19] 0 0
Spain
State/province [19] 0 0
Badalona
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Málaga
Country [23] 0 0
Spain
State/province [23] 0 0
Zaragoza
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taipei
Country [25] 0 0
United Kingdom
State/province [25] 0 0
London
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Manchester
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Sanofi
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03430063