A Phase 3, Randomized, Double-blind Study of Neoadjuvant Chemotherapy plus Nivolumab versus Neoadjuvant Chemotherapy plus Placebo, followed by Surgical Resection and Adjuvant Treatment with Nivolumab or Placebo for Participants with Resectable Stage II-IIIB Non-small Cell Lung Cancer (CheckMate 77T, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 77T)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502658-15-00

Acronym

CA209-77T

Enrollment

252

Registered

2023-07-24

Start date

2019-09-22

Completion date

Unknown

Last updated

2025-10-08

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

Conditions

Resectable Stage II-IIIB Non-small cell lung cancer

Brief summary

Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR)

Detailed description

Overall Survival (OS), Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR), Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review, Incidence of Serious Adverse Events (SAEs), Incidence of Adverse Events (AEs)

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGTAXOL 6 mg/ml

DRUGconcentrato per soluzione per infusione.

DRUG5% Dextrose Solution for Injection

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

DRUGDoce NC 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGBendatax 6 mg/ ml

DRUGCARBO-cell® 10 mg/ml Infusionslösung

DRUGKonzentrat zur Herstellung einer Infusionslösung Carboplatin

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

DRUGCarboplatin Bendalis 10mg/ml

DRUGKonzentrat zur Herstellung einer Infusionslösung

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

DRUGCarbomedac® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUG0.9% Sodium Chloride Solution for Injection

DRUGDocetaxel-Ebewe

DRUG10 mg/ml

DRUGkoncentrat do sporządzania roztworu do infuzji

DRUGPaclitaxel Aurobindo 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCisplatin-Ebewe

DRUG1 mg/ml

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR)	—

Secondary

Measure	Time frame
Overall Survival (OS), Pathologic Complete Response (pCR) Rate as Assessed by Blinded Independent Pathology Review (BIPR), Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review, Incidence of Serious Adverse Events (SAEs), Incidence of Adverse Events (AEs)	—

Countries

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

Outcome results

None listed

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