Advanced Non-Small Cell Lung CarcinomaPhase 2NCT03430063
A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer
A Phase 2 study testing SDREGN2810, SDREGN2810/ipi and HDREGN2810 in people with Advanced Non-Small Cell Lung Carcinoma, run by Regeneron Pharmaceuticals at 31 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Non-Small Cell Lung Carcinoma
- What is being tested?
- SDREGN2810, SDREGN2810/ipi and HDREGN2810
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 31 sitesin 9 countries
- Study dates
- 29 May 2018to 27 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue biopsy sample
- 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
- At least 1 radiographically measureable lesion by computed tomography (CT) per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Who cannot join
- Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
- Active or untreated brain metastases or spinal cord compression
- 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
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
- 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
- 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)
- 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.
Trial locations and contacts
31 sites in 9 countries.
31 sites in 9 countries
South Korea7 sites
Regeneron Research Site
Incheon, 22332
Regeneron Research Site
Jeongnam, 58128
Regeneron Research Site
Seongnam, 463707
Regeneron Research Site
Seoul, 03722
Regeneron Research Site
Seoul, 05505
Regeneron Research Site
Seoul, 06591
Regeneron Research Site
Suwon, 16247
United States6 sites
Regeneron Research Site
Canton, Ohio, 44708
Regeneron Research Site
Los Angeles, California, 90033
Regeneron Research Site
Massillon, Ohio, 44646
Regeneron Research Site
Phoenix, Arizona, 85054
Regeneron Research Site
Scarborough, Maine, 04074
Regeneron Research Site
Whittier, California, 90603
Spain5 sites
Regeneron Research Site
Badalona, 8911
Regeneron Research Site
Barcelona, 08025
Regeneron Research Site
Madrid, 28046
Regeneron Research Site
Málaga, 29010
Regeneron Research Site
Zaragoza, 50009
France3 sites
Regeneron Research Site
Poitiers, 86021
Regeneron Research Site
Rennes, 35033
Regeneron Research Site
Saint-Mandé, 94160
Poland3 sites
Regeneron Research Site
Gdynia, 81519
Regeneron Research Site
Grudziądz, 86300
Regeneron Research Site
Otwock, 05400
United Kingdom3 sites
Regeneron Research Site
London, W1G6AD
Regeneron Research Site
Manchester, M20 4BX
Regeneron Research Site
Plymouth, PL68DH
Belgium2 sites
Regeneron Research Site
Herstal, 4040
Regeneron Research Site
Yvoir, 5530
About this study
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
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.
- Conditions
- Advanced Non-Small Cell Lung Carcinoma
- Being tested
- SDREGN2810, SDREGN2810/ipi, HDREGN2810
- Keywords
- Advanced non-squamous NSCLC, Advanced squamous NSCLC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDREGN2810Drug
Also called REGN2810, cemiplimab
Standard dose intravenous (IV) infusion
SDREGN2810/ipiDrug
Also called REGN2810, cemiplimab, ipilimumab
Combination therapy dose IV
HDREGN2810Drug
Also called REGN2810, cemiplimab
High dose IV
| Study group | Role | What they receive |
|---|---|---|
| SDREGN2810 | Experimental | Not described Receives: Drug: SDREGN2810 |
| SDREGN2810/ipi | Experimental | Not described Receives: Drug: SDREGN2810/ipi |
| HDREGN2810 | Experimental | Not described Receives: Drug: HDREGN2810 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) in Participants Whose Tumors Express Programmed Cell Death Ligand 1 (PD-L1) in <50% of Tumor Cells
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.
Measured: From date of randomization up to 41 months
Secondary outcomes (5)
Overall Response Rate
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.
Measured: From date of randomization up to 41 months
Overall Survival (OS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
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.
Measured: Time from randomization to the date of death (up to 41 months)
Progression Free Survival (PFS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
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.
Measured: Time from randomization up to the date of the first documented tumor progression or death (up to 41 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death
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.
Measured: Up to 41 months
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
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.
Measured: Up to 41 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start29 May 2018
- Primary completion27 Oct 2021
- Study completion27 Oct 2021
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Non-Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430063
- Sponsor's protocol ID
- R2810-ONC-1763
- Other IDs
- 2017-003684-35, 2017
- Status last verified
- Oct 2022
- First submitted
- 29 Jan 2018
- Last updated
- 3 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03430063
- Acronym / sponsor ID
- R2810-ONC-1763
- Conditions
- Advanced Non-Small Cell Lung Carcinoma
- Keywords
- Advanced non-squamous NSCLC, Advanced squamous NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 29 May 2018 (actual)
- Primary completion
- 27 Oct 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Posted 3 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SDREGN2810 | Experimental | Drug: SDREGN2810 |
| SDREGN2810/ipi | Experimental | Drug: SDREGN2810/ipi |
| HDREGN2810 | Experimental | Drug: HDREGN2810 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue biopsy sample
- 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
- At least 1 radiographically measureable lesion by computed tomography (CT) per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Key exclusion criteria (8 listed)
- Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
- Active or untreated brain metastases or spinal cord compression
- 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
- Encephalitis, meningitis, or uncontrolled seizures in the year prior to randomization
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SDREGN2810Also: REGN2810, cemiplimabStandard dose intravenous (IV) infusion | Drug | SDREGN2810 |
| SDREGN2810/ipiAlso: REGN2810, cemiplimab, ipilimumabCombination therapy dose IV | Drug | SDREGN2810/ipi |
| HDREGN2810Also: REGN2810, cemiplimabHigh dose IV | Drug | HDREGN2810 |
Primary outcome
Objective Response Rate (ORR) in Participants Whose Tumors Express Programmed Cell Death Ligand 1 (PD-L1) in <50% of Tumor Cells
Time frame: From date of randomization up to 41 months
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.
5 secondary outcomes
Overall Response Rate
Time frame: From date of randomization up to 41 months
Overall Survival (OS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
Time frame: Time from randomization to the date of death (up to 41 months)
Progression Free Survival (PFS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells
Time frame: Time from randomization up to the date of the first documented tumor progression or death (up to 41 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs Resulting in Death
Time frame: Up to 41 months
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
Time frame: Up to 41 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
31 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SDREGN2810, SDREGN2810/ipi and HDREGN2810 in people with Advanced Non-Small Cell Lung Carcinoma, run by Regeneron Pharmaceuticals at 31 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in South Korea, United States, Spain, France, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) in Participants Whose Tumors Express Programmed Cell Death Ligand 1 (PD-L1) in <50% of Tumor Cells (time frame: From date of randomization up to 41 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.