A Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreated, Locally Advanced Nonsmall Cell Lung Cancer (LA NSCLC)

Conditions

Previously Untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

Brief summary

Progression Free Survival (PFS) Assessed by RECIST 1.1 per Blinded Independent Central Review (BICR)

Detailed description

OS for Arm A vs Arm C, Overall Survival (OS) for Arm B and Arm C, Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C, Overall Survival (OS) for Arm A and Arm B, Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B, Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR), Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR), Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR), Progression-free survival (PFS) by RECIST 1.1 per investigator assessment, Objective response rate (ORR) by RECIST 1.1 per investigator assessment, DoR by RECIST 1.1 per investigator assessment, TTR by RECIST 1.1 per investigator assessment, Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment, Incidence of adverse events (AEs), Incidence of serious adverse events (SAEs), Proportion of participants without symptom deterioration based on NSCLC-SAQ

Related papers

No related papers found yet.

Interventions

DRUGCarbomedac® 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGDURVALUMAB

DRUGCarboplatin Bendalis 10mg/ml

DRUGKonzentrat zur Herstellung einer Infusionslösung

DRUGCisplatin-Ebewe

DRUG1 mg/ml

DRUGkoncentrat do sporządzania roztworu do infuzji

DRUGETO-cell® 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGPaclitaxel Aurobindo 6 mg/ml Konzentrat zur Herstellung einer Infusionslösung

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

DRUGCARBO-cell® 10 mg/ml Infusionslösung

DRUGKonzentrat zur Herstellung einer Infusionslösung Carboplatin

DRUGBendatax 6 mg/ ml

DRUGCISPLATIN

DRUGPACLITAXEL

DRUGCARBOPLATIN

DRUGPEMETREXED DISODIUM

DRUGETOPOSIDE

DRUGIpilimumab

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

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

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS) Assessed by RECIST 1.1 per Blinded Independent Central Review (BICR)	—

Secondary

Measure	Time frame
OS for Arm A vs Arm C, Overall Survival (OS) for Arm B and Arm C, Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C, Overall Survival (OS) for Arm A and Arm B, Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B, Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR), Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR), Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR), Progression-free survival (PFS) by RECIST 1.1 per investigator assessment, Objective response rate (ORR) by RECIST 1.1 per investigator assessment, DoR by RECIST 1.1 per investigator assessment, TTR by RECIST 1.1 per investigator assessment, Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment, Incidence of adverse events (AEs), Incidence of serious adverse events (SA	—

Measure

Time frame

OS for Arm A vs Arm C, Overall Survival (OS) for Arm B and Arm C, Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm B and Arm C, Overall Survival (OS) for Arm A and Arm B, Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A and Arm B, Objective Response Rate (ORR) by RECIST 1.1 per Blinded Independent Central Review (BICR), Duration of Response (DoR) by RECIST 1.1 per Blinded Independent Central Review (BICR), Time to Response (TTR) by RECIST 1.1 per Blinded Independent Central Review (BICR), Progression-free survival (PFS) by RECIST 1.1 per investigator assessment, Objective response rate (ORR) by RECIST 1.1 per investigator assessment, DoR by RECIST 1.1 per investigator assessment, TTR by RECIST 1.1 per investigator assessment, Time to death or distant metastases (TTDM) by RECIST 1.1 per Investigator assessment, Incidence of adverse events (AEs), Incidence of serious adverse events (SA

—

Countries

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

Outcome results

None listed