A Randomized, Double-Blind, Phase II Study of BMS-986315 and Nivolumab in Combination with Chemotherapy Versus Nivolumab in Combination with Chemotherapy as First-line Treatment for Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503007-22-00

Acronym

CA0471009

Enrollment

Registered

2024-01-22

Start date

Unknown

Completion date

2024-02-29

Last updated

2024-02-01

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

Part 1: Main endpoints include incidence of all adverse events (AEs), including AEs leading to discontinuation, and death (per CTCAE v5.0)., Part 2: Main endpoint is the Objective Response Rate (ORR) assessed by BICR (a blinded independent central review committee).

Detailed description

Part 2: Secondary endpoints include summary measures of BMS-986315 PK parameters and additional anti-tumor efficacy parameters, such as PFS, by BICR.

Interventions

DRUGCISPLATIN

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGPACLITAXEL

DRUGanti-NKG2A mAb

DRUGCARBOPLATIN

DRUGPEMETREXED DISODIUM

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: Main endpoints include incidence of all adverse events (AEs), including AEs leading to discontinuation, and death (per CTCAE v5.0)., Part 2: Main endpoint is the Objective Response Rate (ORR) assessed by BICR (a blinded independent central review committee).	—

Secondary

Measure	Time frame
Part 2: Secondary endpoints include summary measures of BMS-986315 PK parameters and additional anti-tumor efficacy parameters, such as PFS, by BICR.	—

Countries

France, Italy, Poland, Romania, Spain

Outcome results

None listed

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