REGN2810 (Anti-PD-1 Antibody), Platinum-based Doublet Chemotherapy, and Ipilimumab (Anti-CTLA-4 Antibody) Versus Pembrolizumab Monotherapy in Patients With Lung Cancer

NCT03515629 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: R2810-ONC-161112017-001041-27
• Study Type: interventional
• Target: 5
• Locations: 3 countries
• Sites: 3

Brief Summary

The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as "REGN2810/chemo/ipi") with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.

Conditions

Non-small Cell Lung Cancer

Keywords

Stage IIIB; Stage IV; Non-squamous NSCLC; Squamous NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) as Assessed by a Blinded Independent Review Committee (IRC) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Assessments

  Per protocol, the final analysis of PFS was to be performed after observing 142 PFS events in the pembrolizumab treatment arm. PFS was not assessed due to insufficient data collected.

  Up to 32 months

Secondary Outcomes (11)

• Overall Survival (OS)

  Up to 32 months

• Objective Response Rate (ORR)

  Up to 32 months

• Number of Treatment-Emergent Adverse Events (TEAEs)

  Up to 32 months

• Number of Participants With Dose-Limiting Toxicities (DLTs)

  Up to 32 months

• Number of Participants With Any Serious TEAEs

  Up to 32 months

Study Arms (3)

Pembrolizumab

ACTIVE COMPARATOR

Pembrolizumab

Drug: Pembrolizumab

REGN2810/ipi

EXPERIMENTAL

REGN2810/ipi

Drug: REGN2810/ipi

REGN2810/chemo/ipi

EXPERIMENTAL

REGN2810/chemo/ipi

Drug: REGN2810/chemo/ipi

Interventions

REGN2810/ipi DRUG

REGN2810 plus ipilimumab

Also known as: cemiplimab

REGN2810/ipi

REGN2810/chemo/ipi DRUG

REGN2810 plus chemotherapy plus Ipilimumab

Also known as: cemiplimab

REGN2810/chemo/ipi

Pembrolizumab DRUG

Reference drug administered IV infusion

Pembrolizumab

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 with stage IIIB or stage IV disease, who received no prior systemic treatment for recurrent or metastatic NSCLC
• Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample which has not previously been irradiated
• Expression of PD-L1 in ≥50% of tumor cells determined by the commercially available assay performed by the central laboratory
• At least 1 radiographically measureable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
• Anticipated life expectancy of at least 3 months

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 informed consent
• History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of 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 risk of immune-related treatment-emergent adverse events (irTEAEs)
• Previous treatment with idelalisib at any time (ZYDELIG®)
• 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 (3)

Regeneron Research Site

St. Petersburg, Florida, 33709, United States

Location

Regeneron Research Site

Cremona, 26100, Italy

Location

Regeneron Research Site

Vilnius, 08660, Lithuania

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cemiplimab; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 3, 2018
• Study Start: July 2, 2018
• Primary Completion: July 29, 2021
• Study Completion: July 29, 2021
• Last Updated: November 16, 2022
• Results First Posted: November 16, 2022

Record last verified: 2022-10

Locations

US (1); IT (1); LI (1)