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

NCT ID: NCT03515629

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-02
• Study Completion Date: 2021-07-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pembrolizumab

Pembrolizumab

Group Type: ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type: DRUG

Reference drug administered IV infusion

REGN2810/ipi

REGN2810/ipi

Group Type: EXPERIMENTAL

REGN2810/ipi

Intervention Type: DRUG

REGN2810 plus ipilimumab

REGN2810/chemo/ipi

REGN2810/chemo/ipi

Group Type: EXPERIMENTAL

REGN2810/chemo/ipi

Intervention Type: DRUG

REGN2810 plus chemotherapy plus Ipilimumab

Interventions

REGN2810/ipi

REGN2810 plus ipilimumab

Intervention Type: DRUG

REGN2810/chemo/ipi

REGN2810 plus chemotherapy plus Ipilimumab

Intervention Type: DRUG

Pembrolizumab

Reference drug administered IV infusion

Intervention Type: DRUG

Other Intervention Names

cemiplimab; cemiplimab

Eligibility Criteria

Inclusion Criteria

1. 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

2. Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample which has not previously been irradiated

3. Expression of PD-L1 in ≥50% of tumor cells determined by the commercially available assay performed by the central laboratory

4. 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

5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

6. Anticipated life expectancy of at least 3 months

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 informed consent

5. 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

6. 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)

7. Previous treatment with idelalisib at any time (ZYDELIG®)

8. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Research Site

St. Petersburg, Florida, United States

Regeneron Research Site

Cremona, , Italy

Regeneron Research Site

Vilnius, , Lithuania

Countries

United States; Italy; Lithuania

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-001041-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R2810-ONC-16111

Identifier Type: -

Identifier Source: org_study_id