Principal Investigator:
Study sponsor: Eli Lilly and Co.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. The study drug works by attaching itself and keeping the mutated gene in an inactive form so that it stops the tumor cells that have this mutation from continuing to grow. The study has 2 parts; Part A – patients are randomly selected to either Study drug in combination with Pembrolizumab (Keytruda), or to Placebo in combination with Pembrolizumab. Part B – patients are randomly selected to either study drug + pembrolizumab + chemotherapy, OR to placebo + pembrolizumab + chemotherapy. Regardless of which combination, patients still receive at least standard therapy.
Inclusion Criteria
– Must be at least 18 years or older.
– Must have confirmed non-small cell lung cancer with stage IIIB-IIIC or stage IV disease.
– Must have confirmed KRAS G12C mutation.
– Must have a known PD-L1 expression as determined by lab tests.
– Must have measurable disease based on RECIST 1.1
– ECOG of 0 – 1
– Have life expectancy of at least 12 weeks
– Must be able to swallow capsules.
– Women of childbearing potential must have negative serum pregnancy test within 24hrs prior to first dose and must not breastfeed during treatment and for at least 180 days after the last dose is given.
Additional criteria may apply and will be discussed with physician and research team.
Exclusion Criteria
– Patient has additional targetable mutation or alteration in genes such as EGFR, ALK, BRAF, HER2, MET, ROS1, RET, or NTRK1/2/3.
– Has known brain metastasis or carcinomatous meningitis. Participants with brain mets may participate in study if any treatment for CNS was completed at least 14 days prior to study start. Patient must also be radiologically, neurologically, and clinically stable for at least 14 days prior to being randomized. Patient also allowed to participate if brain mets are asymptomatic.
– Patient has significant cardiovascular disease or history of myocardial infarct or unstable angina for 6 months prior to study start.
– Has prolonged QT interval as determined by ECG.
– Has uncontrolled, disease-related, pericardial or pleural effusion.
– History of pneumonitis or interstitial lung disease that required treatment with steroids, or has current pneumonitis/interstitial lung disease.
– Has autoimmune disease that has required treatment in the last 2 years. (Replacement therapy such as thyroxine, insulin or physiologic corticosteroids for adrenal or pituitary insufficiency are allowed.)
– History or solid organ transplant or allogenic stem cell transplant.
– Has active fungal or bacterial infection, HIV, or viral hepatitis (A, B, or C). HIV patients must be on ART and have well-controlled disease as defined by specific criteria at screening.
– Patient has pre-existing medical condition that, in the opinion of the treating physician, would interfere with the patient’s ability to be on the trial.
– Have significant active malabsorption syndrome or other condition that would affect the patient’s ability to absorb the study drug.
– Other known malignancy that is progressing and has required active treatment within the past 2 years.
Additional criteria may apply and will be discussed with the physician and research team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
