A Global, Randomized, Phase 3, Open-Label Study of REGN2810 (Anti-PD-1 Antibody) versus Platinum-Based Chemotherapy in First-Line Treatment of Patients with Advanced or Metastatic PD-L1 + Non-Small Cell Lung Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515052-20-00

Acronym

R2810-ONC-1624

Enrollment

Registered

2024-09-26

Start date

2017-09-20

Completion date

2025-04-18

Last updated

2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Brief summary

Overall survival (OS), Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1

Detailed description

Objective response rates (ORR), Best overall response (BOR), Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies, Change from baseline in quality of life (QoL) scores as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13), Incidence of Adverse Events (AEs), Incidence of serious adverse events (SAEs), Incidence of deaths, Incidence of laboratory abnormalities, Measure concentrations of cemiplimab in serum, Characterize the pharmacokinetics (PK) of cemiplimab

Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGArmisarte 25 mg/ml concentrate for solution for infusion

DRUGGemcitabine 2 g Powder for Solution for Infusion

DRUGPaclitaxel 6 mg/ml Concentrate for Solution for Infusion

DRUGCarboplatin 10 mg/ml concentrate for solution for infusion

DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS), Progression-free survival (PFS) as assessed by a blinded Independent review committee (IRC) using RECIST 1.1	—

Secondary

Measure	Time frame
Objective response rates (ORR), Best overall response (BOR), Compare the duration of response (DOR) of cemiplimab versus platinum based chemotherapies, Change from baseline in quality of life (QoL) scores as assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Change from baseline in in lung cancer symptom scores as measured by the EORTC Lung Cancer 13 (EORTC QLQ-LC13), Incidence of Adverse Events (AEs), Incidence of serious adverse events (SAEs), Incidence of deaths, Incidence of laboratory abnormalities, Measure concentrations of cemiplimab in serum, Characterize the pharmacokinetics (PK) of cemiplimab	—

Measure

Time frame

—

Countries

Bulgaria, Czechia, Greece, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026