A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Conditions

Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer

Brief summary

Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR), Stage 2: Overall Survival (OS), Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR), Stage 2: Overall Survival (OS)

Detailed description

Stage 1: Progression Free Survival (PFS), Stage 1: Duration of Response (DOR), Stage 1: Overall Survival (OS), Stage 2: Progression Free Survival (PFS), Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR), Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17), Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17, Stage 2: Progression Free Survival per Investigator, Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per Investigator, Stage 2: Duration of Response (DOR), Stage 2: DOR per investigator, Stage 1: Progression Free Survival (PFS), Stage 1: Duration of Response (DOR), Stage 1: Overall Survival (OS), Stage 2: Progression Free Survival (PFS), Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR), Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17), Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17, Stage 2: Progression Free Survival per Investigator, Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per Investigator, Stage 2: Duration of Response (DOR), Stage 2: DOR per investigator

Related papers

No related papers found yet.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGLivmoniplimab

DRUGCarboplatin 10 mg/ml Intravenous Infusion

DRUGPemetrexed medac 500 mg powder for concentrate for solution for infusion

DRUGCisplatin 1mg/ml Injection BP

DRUGBudigalimab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR), Stage 2: Overall Survival (OS), Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR), Stage 2: Overall Survival (OS)	—

Secondary

Measure	Time frame
Stage 1: Progression Free Survival (PFS), Stage 1: Duration of Response (DOR), Stage 1: Overall Survival (OS), Stage 2: Progression Free Survival (PFS), Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR), Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17), Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17, Stage 2: Progression Free Survival per Investigator, Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per Investigator, Stage 2: Duration of Response (DOR), Stage 2: DOR per investigator, Stage 1: Progression Free Survival (PFS), Stage 1: Duration of Response (DOR), Stage 1: Overall Surv	—

Measure

Time frame

Stage 1: Progression Free Survival (PFS), Stage 1: Duration of Response (DOR), Stage 1: Overall Survival (OS), Stage 2: Progression Free Survival (PFS), Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR), Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17), Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17, Stage 2: Progression Free Survival per Investigator, Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per Investigator, Stage 2: Duration of Response (DOR), Stage 2: DOR per investigator, Stage 1: Progression Free Survival (PFS), Stage 1: Duration of Response (DOR), Stage 1: Overall Surv

—

Countries

Belgium, France, Netherlands, Spain

Outcome results

None listed

A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) – LIVIGNO-4