A Study of REGN2810 and Ipilimumab in Patients With Lung Cancer

NCT03430063 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: R2810-ONC-17632017-003684-35
• Study Type: interventional
• Target: 28
• Locations: 9 countries
• Sites: 31

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.

Conditions

Advanced Non-Small Cell Lung Carcinoma

Keywords

Advanced non-squamous NSCLC; Advanced squamous NSCLC

Outcome Measures

Primary Outcomes (1)

• 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.

  From date of randomization up to 41 months

Secondary Outcomes (5)

• Overall Response Rate

  From date of randomization up to 41 months

• Overall Survival (OS) in Participants With Tumor PD-L1 Expression Levels <50% of Tumor Cells

  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 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

  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

  Up to 41 months

Study Arms (3)

SDREGN2810

EXPERIMENTAL

Drug: SDREGN2810

SDREGN2810/ipi

EXPERIMENTAL

Drug: SDREGN2810/ipi

HDREGN2810

EXPERIMENTAL

Drug: HDREGN2810

Interventions

SDREGN2810 DRUG

Standard dose intravenous (IV) infusion

Also known as: REGN2810, cemiplimab

SDREGN2810

SDREGN2810/ipi DRUG

Combination therapy dose IV

Also known as: REGN2810, cemiplimab, ipilimumab

SDREGN2810/ipi

HDREGN2810 DRUG

High dose IV

Also known as: REGN2810, cemiplimab

HDREGN2810

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Sanofi: collaborator

Study Sites (31)

Regeneron Research Site

Phoenix, Arizona, 85054, United States

Location

Regeneron Research Site

Los Angeles, California, 90033, United States

Location

Regeneron Research Site

Whittier, California, 90603, United States

Location

Regeneron Research Site

Scarborough, Maine, 04074, United States

Location

Regeneron Research Site

Canton, Ohio, 44708, United States

Location

Regeneron Research Site

Massillon, Ohio, 44646, United States

Location

Regeneron Research Site

Herstal, 4040, Belgium

Location

Regeneron Research Site

Yvoir, 5530, Belgium

Location

Regeneron Research Site

Poitiers, 86021, France

Location

Regeneron Research Site

Rennes, 35033, France

Location

Regeneron Research Site

Saint-Mandé, 94160, France

Location

Regeneron Research Site

Gauting, 82131, Germany

Location

Regeneron Research Site

Gdynia, 81519, Poland

Location

Regeneron Research Site

Grudziądz, 86300, Poland

Location

Regeneron Research Site

Otwock, 05400, Poland

Location

Regeneron Research Site

Incheon, 22332, South Korea

Location

Regeneron Research Site

Jeongnam, 58128, South Korea

Location

Regeneron Research Site

Seongnam, 463707, South Korea

Location

Regeneron Research Site

Seoul, 03722, South Korea

Location

Regeneron Research Site

Seoul, 05505, South Korea

Location

Regeneron Research Site

Seoul, 06591, South Korea

Location

Regeneron Research Site

Suwon, 16247, South Korea

Location

Regeneron Research Site

Badalona, 8911, Spain

Location

Regeneron Research Site

Barcelona, 08025, Spain

Location

Regeneron Research Site

Madrid, 28046, Spain

Location

Regeneron Research Site

Málaga, 29010, Spain

Location

Regeneron Research Site

Zaragoza, 50009, Spain

Location

Regeneron Research Site

Taipei, 11217, Taiwan

Location

Regeneron Research Site

London, W1G6AD, United Kingdom

Location

Regeneron Research Site

Manchester, M20 4BX, United Kingdom

Location

Regeneron Research Site

Plymouth, PL68DH, United Kingdom

Location

MeSH Terms

Interventions

cemiplimab; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

All participants' tumors had PD-L1 expression levels of \<50% at baseline. Therefore, the results do not present efficacy for participants with PD-L1 expression levels of ≥50% of tumor cells versus all participants.

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 12, 2018
• Study Start: May 29, 2018
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: November 3, 2022
• Results First Posted: November 3, 2022

Record last verified: 2022-10

Locations

TW (1); US (6); DE (1); BE (2); ES (5); FR (3); GB (3); PL (3); KR (7)