Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
estimated completion

Description

Summary

The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

Official Title

An Adaptive Phase III, Multicenter, Randomized, Open-Label, Controlled Study of M7824 (Bintrafusp Alfa) Versus Pembrolizumab as a First-line Treatment in Patients With PD-L1 Expressing Advanced Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer M7824 Pembrolizumab PD-L1-tumor Expression INTR@PID Lung 037 Bintrafusp alfa Lung Neoplasms Carcinoma, Non-Small-Cell Lung

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed diagnosis of advanced NSCLC
  • Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease. Confirmation of resolution of toxic effects of previous neoadjuvant/adjuvant chemotherapy therapy to Grade less than or equal to 1. For radiation toxicity or prior major surgeries, participants should have recovered from side effects and/or complications
  • Have measurable disease based on RECIST 1.1
  • Have a life expectancy of at least 3 months
  • Availability of tumor tissue (less than 6 months old) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
  • PD-L1 high status as determined by central testing
  • Other protocol defined inclusion criteria could apply

You CAN'T join if...

  • Participants with nonsquamous NSCLC histologies whose tumor harbors any of the following molecular alterations and targeted therapy is locally approved: epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation
  • Has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy of greater than 30 units of gray (Gy) within 6 months prior to the first dose of study
  • Known severe hypersensitivity to investigational products (M7824 or pembrolizumab), or any components in their formulations
  • Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years
  • Other protocol defined exclusion criteria could apply

Locations

  • UC Irvine Medical Center
    Orange California 92868 United States
  • Cedars Sinai Medical Center - Inflammatory Bowel Disease Center (Clinic
    Los Angeles California 90048 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
EMD Serono Research & Development Institute, Inc.
Links
INTR@PID Clinical Trial Program Trial Awareness and Transparency website US Medical Information website, Medical Resources
ID
NCT03631706
Phase
Phase 3
Study Type
Interventional
Last Updated