SWOG S2302

Clinical Trial Title Pragmatica - Lung: A Prospective Randomized Study of Ramucirumab Plus Pembrolizumab Versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
Trial Status Open to Enrollment
Start Date 04/06/2023
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Lung Cancer
Description 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.
Eligibility Criteria

Eligibility Criteria

  • Participants must be ≥ 18 years old.
  • Participants must have Zubrod Performance Status of 0-2.
  • 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 not have received more than one line of anti-PD-1 or anti-PD-L1 for Stage IV or recurrent disease.
  • 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 must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating physician) during or after this regimen.
  • Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study - Full Text View - ClinicalTrials.gov
Principal Investigator Mei Dong, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org