Principal Investigator:
Study Sponsor: Summit Therapeutics
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of the study is to compare how effective the study drug Ivonescimab is vs. Pembrolizumab (Keytruda) at treating metastatic non small-cell lung cancer. This is a randomized study, meaning you will randomly be assigned to either the study drug arm or the Pembrolizumab arm. It is also blinded, which means you and your doctor will not know whether you are receiving the study drug or the standard of care drug. Only the pharmacist which prepares the drug will know which drug you are receiving.
Inclusion Criteria:
– Must be 18 years or older.
– ECOG of 0 – 1.
– Expected life expectancy of at least 3 months or greater.
– has metastatic (Stage IV) non small-cell lung cancer (Squamous OR non-squamous).
– Has high PD-L1 expression of at least 50% or greater.
– Has at least 1 measurable lesion per RECIST 1.1.
– No prior treatment for metastatic non small-cell lung cancer. Patients receiving adjuvant, neoadjuvant chemotherapy, or curative-intent chemoradiation may be eligible if their last therapy was at least 6 months prior to developing metastatic disease.
– Has adequate organ function as determined by local lab tests.
– Female patients of childbearing potential must test negative on serum pregnancy test, and must agree to highly effective methods of contraception. Male patients must also agree to highly effective methods of contraception while on study drug and up to 120 days after the last dose.
*Additional inclusion criteria may apply and will be discussed with the physician and study team.
Exclusion Criteria:
– Has small-cell lung cancer.
– Has known genetic mutations for which there exist targeted therapies.
– Has received prior therapy for non small-cell lung cancer in the metastatic setting.
– Is enrolled in another clinical trial (unless the clinical trial is not interventional – meaning you are not receiving a study drug).
– Evidence per CT that the tumor is invading blood vessels or organs. Additionally, patient is ineligible if the physician determines there is a significant risk of bleeding.
– Symptomatic central nervous system metastasis with hemorrhagic features, metastasis of > or = to 1.5cm, radiation within 7 days prior to randomization, or a need for radiation within the first cycle.
– Other prior malignancies unless patient has received curative therapy with no disease recurrence for 3 years prior to being randomized.
– Active autoimmune or lung disease requiring prednisone of >/=10mg per day or equivalent. (Exceptions include corticosteroid replacement therapy, insulin, thyroxine.)
– History of major disease prior to randomization such as significant cardiac events (congestive heart failure, myocardial infarct, etc.), Grade 3 thrombus event, exacerbation of COPD, history of GI-tract perforation or GI obstruction.
– Patients with >30Gy of radiation to chest within 6 months prior to randomization.
– Pre-existing peripheral neuropathy of Grade 2 or higher.
– Live vaccine within 4 weeks.
– Sever infection, or major surgery within 4 weeks prior to being randomized.
– History of bleeding or coagulation issues within 4 weeks prior to randomization.
– Poorly controlled hypertension, uncontrolled pleural or pericardial effusions, or symptomatic ascites.
– Active or prior history of inflammatory bowel disease, known HIV, or history of pneumonia requiring systemic steroids.
*Additional exclusion criteria may apply and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com
