FindTrial
Sign In

A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti- PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515051-38-00
Acronym
R2810-ONC-16113
Enrollment
117
Registered
2024-09-26
Start date
2018-07-20
Completion date
2025-02-27
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

Detailed description

Progression-free survival, Objective response rate, Duration of Response (DOR), Best overall response (BOR), Incidence of Treatment-emergent adverse events (TEAEs), Part 1 only: Incidence of Dose-limiting toxicities (DLTs), Incidence of serious adverse events (SAEs), Incidence of deaths, Incidence of laboratory abnormalities, Overall survival rate, Quality of life as measured by EORTC QLQ-C30, Quality of life as measured by EORTC QLQ-LC13

Interventions

DRUGPaclitaxel 6 mg/ml Concentrate for Solution for Infusion
DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion
DRUGArmisarte 25 mg/ml concentrate for solution for infusion
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
DRUGCarboplatin 10 mg/ml concentrate for solution for infusion
DRUGLIBTAYO 350 mg concentrate for solution for infusion.

Sponsors

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall survival—

Secondary

MeasureTime frame
Progression-free survival, Objective response rate, Duration of Response (DOR), Best overall response (BOR), Incidence of Treatment-emergent adverse events (TEAEs), Part 1 only: Incidence of Dose-limiting toxicities (DLTs), Incidence of serious adverse events (SAEs), Incidence of deaths, Incidence of laboratory abnormalities, Overall survival rate, Quality of life as measured by EORTC QLQ-C30, Quality of life as measured by EORTC QLQ-LC13—

Countries

France, Greece, Ireland, Poland

Outcome results

None listed

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