A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

• Sponsor: Regeneron Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03430063
• Collaborator: Sanofi (Industry)
• Enrollment: 28
• Locations: 31
• Arms: 3
• Actual Duration (Months): 41
• Patients Per Site: 0.9
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Non-Small Cell Lung Carcinoma	Drug: SDREGN2810; Drug: SDREGN2810/ipi; Drug: HDREGN2810	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 29, 2018
• Actual Primary Completion Date: Oct 27, 2021
• Actual Study Completion Date: Oct 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SDREGN2810	Drug: SDREGN2810; Standard dose intravenous (IV) infusion; Other Names: REGN2810 cemiplimab
Experimental: SDREGN2810/ipi	Drug: SDREGN2810/ipi; Combination therapy dose IV; Other Names: REGN2810 cemiplimab ipilimumab
Experimental: HDREGN2810	Drug: HDREGN2810; High dose IV; Other Names: REGN2810 cemiplimab

Outcome Measures

Primary Outcome Measures

1. ORR [Up to 31 months]

   Proportion of patients achieving complete response (CR) or partial response (PR) as assessed by a blinded Independent Review Committee (IRC) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in patients whose tumors express PD-L1 in <50% of tumor cells

Secondary Outcome Measures

1. ORR in all patients [Up to 31 months]

2. Overall survival (OS) in patients whose tumors express PD-L1 in <50% of tumor cells [Up to 31 months]

3. OS in all patients [Up to 31 months]

4. Progression free survival (PFS) in patients whose tumors express PD-L1 in <50% of tumor cells [Up to 31 months]

5. PFS in all patients [Up to 31 months]

6. Incidences of treatment emergent adverse events (TEAEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grading system [Up to 31 months]

7. Incidences of serious adverse events (SAEs) as assessed by the NCI-CTCAE grading system [Up to 31 months]

8. Incidences of deaths [Up to 31 months]

9. Incidences of laboratory abnormalities as assessed by the NCI-CTCAE grading system [Up to 31 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regeneron Research Site	Phoenix	Arizona	United States	85054
2	Regeneron Research Site	Los Angeles	California	United States	90033
3	Regeneron Research Site	Whittier	California	United States	90603
4	Regeneron Research Site	Scarborough	Maine	United States	04074
5	Regeneron Research Site	Canton	Ohio	United States	44708
6	Regeneron Research Site	Massillon	Ohio	United States	44646
7	Regeneron Research Site	Herstal		Belgium	4040
8	Regeneron Research Site	Yvoir		Belgium	5530
9	Regeneron Research Site	Poitiers		France	86000
10	Regeneron Research Site	Rennes		France	35033
11	Regeneron Research Site	Saint-Mandé		France	94160
12	Regeneron Research Site	Gauting		Germany	82131
13	Regeneron Research Site	Incheon		Korea, Republic of	22332
14	Regeneron Research Site	Jeongnam		Korea, Republic of	58128
15	Regeneron Research Site	Seongnam		Korea, Republic of	463707
16	Regeneron Research Site	Seoul		Korea, Republic of	03722
17	Regeneron Research Site	Seoul		Korea, Republic of	05505
18	Regeneron Research Site	Seoul		Korea, Republic of	06591
19	Regeneron Research Site	Suwon		Korea, Republic of	16247
20	Regeneron Research Site	Gdynia		Poland	81519
21	Regeneron Research Site	Grudziądz		Poland	86300
22	Regeneron Research Site	Otwock		Poland	05400
23	Regeneron Research Site	Badalona		Spain	8911
24	Regeneron Research Site	Barcelona		Spain	08025
25	Regeneron Research Site	Madrid		Spain	28046
26	Regeneron Research Site	Málaga		Spain	29010
27	Regeneron Research Site	Zaragoza		Spain	50009
28	Regeneron Research Site	Taipei		Taiwan	11217
29	Regeneron Research Site	London		United Kingdom	W1G6AD
30	Regeneron Research Site	Manchester		United Kingdom	M20 4BX
31	Regeneron Research Site	Plymouth		United Kingdom	PL68DH

Sponsors and Collaborators

• Regeneron Pharmaceuticals
• Sanofi

Investigators

• Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03430063
• Other Study ID Numbers: R2810-ONC-1763; 2017-003684-35
• First Posted: Feb 12, 2018
• Last Update Posted: Nov 17, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Regeneron Pharmaceuticals: Advanced non-squamous NSCLC; Advanced squamous NSCLC
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung; Ipilimumab; Cemiplimab

Study Results

No Results Posted as of Nov 17, 2021