Randomized, Open-Label, Phase 3 Trial of Nivolumab plus Ipilimumab or Nivolumab plus Platinum-Doublet Chemotherapy versus Platinum-Doublet Chemotherapy in Early Stage NSCLC

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501360-18-00

Acronym

CA209-816

Enrollment

194

Registered

2023-04-28

Start date

2017-03-15

Completion date

2024-12-03

Last updated

2024-12-03

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

Conditions

Early Stage Non-Small Cell Lung Cancer (NSCLC)

Brief summary

Event-Free Survival, Pathological Complete Response

Detailed description

Overall survival (OS), Major pathological response (MPR), Time to Death or Distant Metastases (TTDM)

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGDocetaxel Hospira 10 mg/ml Concentrate for Solution for Infusion

DRUGVinorelbin NC 10 mg/ml - Konzentrat zur Herstellung einer Infusionslösung

DRUGGemcitabine 38 mg/ml Concentrate for Solution for Infusion

DRUGCarboplatin Bendalis 10mg/ml

DRUGKonzentrat zur Herstellung einer Infusionslösung

DRUGTAXOL 6 mg/ml

DRUGconcentrato per soluzione per infusione

DRUGCarbomedac® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCARBO-cell® 10 mg/ml Infusionslösung

DRUGKonzentrat zur Herstellung einer Infusionslösung Carboplatin

DRUGCISPLATIN-EBEWE

DRUG1 MG/ML

DRUGKONCENTRAT DO SPORZĄDZANIA ROZTWORU DO INFUZJI

DRUGIpilimumab

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

DRUGVinorelbin Aurobindo 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

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

DRUGPaclitaxel Aurobindo 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGGemcitabine 1 g Powder for Solution for Infusion

DRUGBendatax 6 mg/ ml

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

DRUGDocetaxel-Ebewe

DRUG10 mg/ml

DRUGkoncentrat do sporządzania roztworu do infuzji

DRUGNavirel 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGDoce NC 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Event-Free Survival, Pathological Complete Response	—

Secondary

Measure	Time frame
Overall survival (OS), Major pathological response (MPR), Time to Death or Distant Metastases (TTDM)	—

Countries

France, Italy, Romania, Spain

Outcome results

None listed

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