M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

  • Interventional
  • Recruiting
  • NCT03631706
Eligibility Details Visit Clinicaltrials.gov

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

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

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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

        Exclusion Criteria:

         - 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

At a Glance

National Government IDNCT03631706

IRB#IRB18-1117

Lead SponsorEMD Serono Research & Development Institute, Inc.

Lead PhysicianChristine Bestvina

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting