Purpose of this Study
We are doing this study to find out if a pair of investigational drugs called ramucirumab and pembrolizumab (the study drugs) are a safe and effective treatment for your form of cancer. We want to know how well the study drugs work in comparison to the standard treatment for Stage IV or recurrent NSCLC.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with Stage IV NSCLC that is Stage IV and/or recurrent (has returned after treatment)
- Have received at least one line of anti-PD-1 or anti-PD-L1 therapy for any stage of NSCLC
- Have not received more than one line of anti-PD-1 or anti-PD-L1 for Stage IV or recurrent disease
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will be assigned to 1 of 2 treatment groups:
- Group 1 will get the standard treatment. If you are in this group, you and your doctor will decide which treatment is best for you from the available approved options.
- Group 2 will get the study drugs. If you are in this group, you will receive both drugs every 21 days for up to 2 years.
Locations
Duke University Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
S2302: 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
Principal Investigator
Joel
Rivera concepcion
Protocol Number
PRO00113580
NCT ID
NCT05633602
Phase
IV
Enrollment Status
Open to Enrollment