Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)

Titre officiel

A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)

Sommaire:

L’objectif de cette étude est d’évaluer l’utilisation d’agents expérimentaux (MK-4830, MK-5890 et lenvatinib [MK-7902]) en association avec le pembrolizumab et une chimiothérapie à base d’étoposide/platine pour le traitement de première ligne du cancer du poumon à petites cellules au stade de stade étendu (SE). Aucune vérification d’hypothèse formelle ne sera effectuée dans le cadre de cette étude.

Description de l'essai

Primary Outcome:

• Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1)
• Six-Month Progression-Free Survival (PFS) as Assessed by BICR per RECIST 1.1

• Duration of Response (DOR) as Assessed by BICR per RECIST 1.1
• Progression-Free Survival (PFS) as Assessed by BICR per RECIST 1.1
• Overall Survival (OS)
• Percent Change From Baseline in Tumour Size as Assessed by BICR
• Number of Participants Who Experienced an Adverse Event (AE)
• Number of Participants Who Discontinued Study Treatment Due to an AE
• Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Global Health Status/Quality of Life Scale (Items 29 and 30) at Week 19

Voir cet essai sur ClinicalTrials.gov