A Prospective Randomized Study of Ramucircumab Plus Pembrolizumab Versus Standard of Care for Participants Previously Treated with Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer

Protocol: SWOG – S2302

SCHEMA S2302

Please Note: Below is a brief list of eligibility, please contact Genesys Hurley Cancer Institute, Research Department at (810) 762-8181, (810) 762-8079 or (810) 792-8038 to discuss the complete list of eligibility. Thank you!

Eligibility:

1. Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) which is Stage IV or recurrent.
2. Participants must have received exactly one anti-PD-1 or anti-PD-L1 therapy for advanced disease (Stage IV or recurrent disease, or Stage I-III disease in certain circumstances outlined below). Anti-PD-1 or anti-PD-L1 therapy may have been given alone or in combination with other therapy. For participants who received neoadjuvant, adjuvant, and/or consolidation antiPD-1 or anti-PD-L1 therapy for Stage I-III disease:
   1. If they experienced disease progression within (<=) 365 days from initiation (Cycle 1 Day 1) of anti-PD-1 or anti-PD-L1 therapy, this counts as the single allowed anti-PD-1 or anti-PD-L1 therapy for advanced disease.
   2. If they experienced disease progression more than (>) 365 days from initiation
      (Cycle 1 Day 1) of anti-PD-1 or anti-PD-L1 therapy, this is not considered antiPD-1 or anti-PD-L1 therapy for advanced disease. These participants must have received anti-PD-1 or anti-PD-L1 therapy for Stage IV or recurrent disease.
3. 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 anti-PD-L1 therapy.
4. Participants who received anti-PD-1 or anti-PD-L1 therapy for Stage IV or recurrent disease must have had a best response of stable disease, partial response or complete response (in the opinion of the treating physician) on the anti-PD-1 or anti-PD-L1 therapy for Stage IV or recurrent disease.
5. Participants must have received platinum-based chemotherapy and experienced disease progression (in the opinion of the treating physician) during or after this regimen.
6. Participants with a known sensitizing mutation for which an FDA-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2 and MET sensitizing mutations), must have previously received at least one of the approved therapy(s). Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria are also met.
7. Participants must be ≥ 18 years old.