A Phase 3, Randomized Study of Nivolumab plus Ipilimumab in Combination with Chemotherapy vs Chemotherapy alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508757-75-00

Acronym

CA209-9LA

Enrollment

456

Registered

2024-03-01

Start date

2017-09-18

Completion date

2024-10-18

Last updated

2024-10-28

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

Conditions

Stage IV Non-Small Cell Lung Cancer (NSCLC)

Brief summary

Overall Survival (OS): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy versus (vs)chemotherapy

Detailed description

Progression Free Survival (PFS): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy, Overall Response Rate (ORR): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy, ORR: In participants with different PD-L1 levels, PFS: In participants with different PD-L1 levels, OS: In participants with different PD-L1 levels, ORR: In association with tumor cell total somatic mutation numbers, PFS: In association with tumor cell total somatic mutation numbers, OS: In association with tumor cell total somatic mutation numbers, Blood TMB analysis

Interventions

DRUGPaclitaxel Aurobindo 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGIpilimumab

DRUGCisplatin Teva® 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCARBOPLATIN

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGCisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

DRUGTAXOL 6 mg/ml

DRUGconcentrato per soluzione per infusione.

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGPaclitaxel-GRY® 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCISPLATIN-EBEWE

DRUG1 MG/ML

DRUGKONCENTRAT DO SPORZĄDZANIA ROZTWORU DO INFUZJI

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall Survival (OS): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy versus (vs)chemotherapy	—

Secondary

Measure	Time frame
Progression Free Survival (PFS): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy, Overall Response Rate (ORR): To compare the efficacy of nivolumab + ipilimumab combined with chemotherapy vs chemotherapy, ORR: In participants with different PD-L1 levels, PFS: In participants with different PD-L1 levels, OS: In participants with different PD-L1 levels, ORR: In association with tumor cell total somatic mutation numbers, PFS: In association with tumor cell total somatic mutation numbers, OS: In association with tumor cell total somatic mutation numbers, Blood TMB analysis	—

Measure

Time frame

—

Countries

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

Outcome results

None listed

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