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)

Official Title

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)

Summary:

The purpose of this study is to evaluate the use of investigational agents (MK-4830, MK-5890 and Lenvatinib (MK-7902)) in combination with pembrolizumab and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study.

Trial Description

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
Secondary Outcome:
  • 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

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society