Skip Navigation Links
Pragmatica - Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Pragmatica - Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
 
Region Sponsors
Colorado
SWOG Cancer Research Network
 
Acronym NCT No.
NCT05633602
 
Study Type Phase
Clinical Trial
Phase III
 
Purpose
This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.
 
Detailed Description
 
 
 
Inclusion Criteria
  • Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) which is stage IV or recurrent
  • Participants must have received at least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of NSCLC. Anti-PD-1 or anti-PD-L1 may have been given alone or in combination with other therapy
  • Participants must have experienced disease progression (in the opinion of the treating physician) more than (>) 84 days following initiation (cycle 1 day 1) of their most recent anti-PD-1 or PD-L1 therapy
  • Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent disease, must have had a best response on anti-PD-1 or anti-PD-L1 therapy of stable, partial response or complete response (in the opinion of the treating physician)
  • Participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or anti-PD-L1 therapy as their only line of anti-PD-1 or anti-PD-L1 therapy must have experienced disease progression within (=<) 365 days from initiation (cycle 1 day 1) of anti-PD-1 or PD-L1 therapy
 
Exclusion Criteria
  • Participants must not have received more than one line of anti-PD-1 or anti-PD-L1 for stage IV or recurrent disease
  • Participants must not be receiving or planning to receive another investigational therapy during study participation
 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
  • Surgery (Thoracic)
 
KP Clinical Facility
  • Lone Tree Medical Offices - Lone Tree
 
Clinical Area
  • Oncology (Adult)
  • Surgery (Thoracic)


Principal Investigator:
Alex Menter
Contact Information:
- CTP Team
-ctpcollaborate@kp.org
-Lone Tree Medical Offices - Lone Tree


smilelady1
Do you want to receive
Email Alerts?

Sign Up Here!