A Phase 2 Randomized Study of Relatlimab plus Nivolumab in Combination with Chemotherapy vs. Nivolumab in Combination with Chemotherapy as First Line Treatment for Participants with Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508372-10-00

Acronym

CA224-104

Enrollment

288

Registered

2024-05-06

Start date

2021-05-19

Completion date

Unknown

Last updated

2025-10-24

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, Non Small Cell Lung Cancer

Brief summary

Part 1 •TRAEs leading to discontinuation within 12 weeks after the first dose, Part 2 •ORR per RECIST v1.1 by BICR

Detailed description

Part 1 •Incidence of TRAEs leading to discontinuation, AEs, SAEs, and select AEs, Part 2 •PFS per RECIST v1.1 by BICR

Interventions

DRUGCARBOPLATIN

DRUGPACLITAXEL

DRUGCISPLATIN

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGPEMETREXED DISODIUM

DRUGRelatlimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1 •TRAEs leading to discontinuation within 12 weeks after the first dose, Part 2 •ORR per RECIST v1.1 by BICR	—

Secondary

Measure	Time frame
Part 1 •Incidence of TRAEs leading to discontinuation, AEs, SAEs, and select AEs, Part 2 •PFS per RECIST v1.1 by BICR	—

Countries

Belgium, France, Germany, Ireland, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed

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