Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

Phase 3

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Placebo; Drug: REGN2810; Other: Chemotherapy; Drug: REGN2810/chemo/ipi

• Registration Number: NCT03409614
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

The primary objectives of this study are:

Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in \<50% of tumor cells.

Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

The key secondary objectives are:

Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in \<50% of tumor cells.

Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-24
• Study Start: 2018-03-06
• Primary Completion: 2025-02-27
• Study Completion: 2025-02-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 790

Inclusion Criteria

1. Men and women ≥20 years of age for Japanese patients
2. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC
3. Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample from a metastatic or recurrent site, which has not previously been irradiated
4. Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commercially available assay performed by the central laboratory
5. At least 1 radiographically measurable 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
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
7. Anticipated life expectancy of at least 3 months

Key

Exclusion Criteria

1. Part 1 only: 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 enrollment
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. 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 may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo+Chemo	Placebo	Part 2: Placebo plus chemo
REGN2810+Chemo Part 2	REGN2810	Part 2: REGN2810+chemo
Chemo	Chemotherapy	Part 1: Chemotherapy
REGN2810+AbbrevChemo+ipi	REGN2810/chemo/ipi	Part 1: REGN2810+abbrev chemo+ipi
Chemo	Placebo	Part 1: Chemotherapy
REGN2810+Chemo Part 1	REGN2810	Part 1: REGN2810+chemo

Primary Outcome Measures

Name	Time	Method
Overall survival	Up to 32 months

Secondary Outcome Measures

Name	Time	Method
Incidence of Dose-limiting toxicities (DLTs)	Up to 32 months	Part 1 only
Incidence of laboratory abnormalities	Up to 32 months
Progression-free survival	Up to 32 months
Duration of Response (DOR)	Up to 32 months
Incidence of Treatment-emergent adverse events (TEAEs)	Up to 32 months
Incidence of serious adverse events (SAEs)	Up to 32 months
Overall survival rate	24 months
Best overall response (BOR)	Up to 32 months
Objective response rate	Up to 32 months
Incidence of deaths	Up to 32 months
Quality of life as measured by EORTC QLQ-LC13	Up to 32 months	Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)
Quality of life as measured by EORTC QLQ-C30	Up to 32 months	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

Trial Locations

Locations (4)

Regeneron Research Site #2; 🇹🇭 Ratchathewi, Bangkok, Thailand

Regeneron Research Site; 🇺🇦 Vinnytsia, Ukraine

Regeneron Research Site #1; 🇹🇭 Ratchathewi, Thailand

Regeneron research Site; 🇨🇳 Beijing, China