Summary

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

Description

Summary

The study will evaluate M7824 monotherapy versus pembrolizumab as 1L treatment for participants with advanced NSCLC with high PD-L1-tumor expression.

Official Title

A Phase II, Multicenter, Randomized, Open-Label, Controlled Study of M7824 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 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 either tumor archival material (less than 6 months old) or fresh biopsies collected within 28 days (excluding bone biopsies) before the first dose is mandatory to determine PD-L1 expression level prior to enrollment
  • PD-L1 high status as determined by central PD-L1 test or by prior testing using PD-L1 immunohistochemistry 22C3 pharmDx assay
  • Other protocol defined inclusion criteria could apply

You CAN'T join if...

  • The participant's tumor harbors an epidermal growth factor receptor (EGFR) sensitizing (activating) mutation, anaplastic lymphoma kinase (ALK) translocation, ROS1 rearrangement, or BRAF V600E mutation, if targeted therapy is locally approved
  • 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 accepting new patients
    Orange California 92868 United States
  • California Cancer Associates for Research & Excellence, Inc accepting new patients
    Escondido California 92025 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
EMD Serono Research & Development Institute, Inc.
ID
NCT03631706
Phase
Phase 2
Study Type
Interventional
Last Updated