HARMONi-3 Study: A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the first-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer
Principal Investigator: Kurt Demel, MD
Study sponsor: Summit Therapeutics Sub, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: This is a randomized study – meaning you have a random chance to be assigned to either the study drug arm, which is Ivonescimab (study drug) + chemotherapy, OR to the standard arm, which is Pembrolizumab (Keytruda) + chemotherapy. The main purpose of the study is to look at overall survival of patients that are taking the study drug plus chemo, vs. the patients taking pembrolizumab plus chemo. The study drug works by attacking or interfering with 2 different parts of cancer growth at the same time. It interferes with the development of new blood vessels to the tumor, and also stimulates the body’s immune system to better identify cancer cells and destroy them.
Inclusion Criteria:
– Must be at least 18 years old at time of signing informed consent.
– Must have ECOG of 0-1.
– Must have confirmed squamous non small-cell lung cancer.
– Must have PD-L1 report available, or provide tumor tissue for measurement of PD-L1.
– At least 1 measurable lesion per RECIST 1.1.
– Must not have received prior systemic treatment for metastatic NSCLC.
– Must have adequate organ function as determined by lab tests.
– Women of childbearing potential (WOCP) or partners of WOCP must agree to utilizing highly effective contraception from beginning of screening period through 120 days post last dose.
– Additional inclusion criteria may apply and will be discussed with the physician or study team.
Exclusion Criteria:
– Must be at least 18 years old at time of signing informed consent.
– Must have ECOG of 0-1.
– Must have confirmed squamous non small-cell lung cancer.
– Must have PD-L1 report available, or provide tumor tissue for measurement of PD-L1.
– At least 1 measurable lesion per RECIST 1.1.
– Must not have received prior systemic treatment for metastatic NSCLC.
– Must have adequate organ function as determined by lab tests.
– Women of childbearing potential (WOCP) or partners of WOCP must agree to utilizing highly effective contraception from beginning of screening period through 120 days post last dose.
– Additional inclusion criteria may apply and will be discussed with the physician or study team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
Lisa.Wahowske@ParkNicollet.com
HARMONi-7: Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (TPS ≥ 50%)
Principal Investigator: Kurt Demel, MD
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
HLX10-005-SCLC301-E: A Randomized, Open-label Study of HLX10 plus Chemotherapy (Carboplatin Etoposide) in comparison with Atezolizumab plus Chemotherapy in Previously Untreated US Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).
Principal Investigator: Yan Ji, MD
Study Sponsor: Shanghai Henlius Biotech
Location: HealthPartners Cancer Center at Regions Hospital
Phase of Study: III
Purpose of study: This is a Phase 3 study that is looking to study the effects of the study drug HLX10 combined with chemotherapy on extensive-stage small-cell lung cancer. Patients are randomly assigned to either the experimental arm – the study drug + chemotherapy, or the control arm – Atezolizumab (Tecentriq) + chemotherapy. The study drug works by targeting PD-1, and helps restore the body’s function to recognize and combat cancer cells.
Inclusion Criteria:
– Must be at least 18 years or older.
– Must be diagnosed with extensive-stage small-cell lung cancer.
– Must not have had any previous therapy for ES-SCLC
– Patients that received chemoradiotherapy for limited stage SCLC must be treated with curative intent and must have treatment-free period of at least 6 months from the last course of chemo, radiotherapy, or chemoradiotherapy until diagnosis of extensive stage SCLC.
– Must have at least 1 measurable lesion per RECIST 1.1.
– ECOG of 0 – 1.
– Expected survival of at least 12 weeks.
– Normal organ function as determined by screening lab tests.
– Female patients may meet any of the following: Menopause (menses for at least 1 year), or surgically sterilized, or, if of childbearing potential, must have negative serum pregnancy test within 7 days prior to being randomized to the study, and must agree to using highly contraceptive methods while on study treatment. Additionally, must not be breastfeeding.
– Male patients must agree to abstinence or take contraceptive measures through 6 months post last dose of study treatment.
– Additional criteria may apply, and will be discussed with the physician and study team.
Exclusion Criteria:
– Confirmed mixed small-cell lung cancer.
– Other active malignancies within 5 years or at the same time.
– Patients who are preparing for, or have received an organ or bone marrow transplant.
– Pleural or pericardial effusion requiring intervention, or ascites.
– Patients with known Central Nervous System metastases and/or meningitis at screening. The following will be allowed: subjects with asymptomatic brain metastases – will be required to have regular brain imaging done. Subjects with treated brain mets that have been stable for at least 2 months and with discontinued steroids 3 days prior to study start.
– Patients with spinal cord compression that has not been treated with surgery or radiotherapy.
– Patients with myocardial infarct within half a year prior to first dose, or with poorly controlled arrhythmias.
– Class 3 or 4 cardiac insufficiency or LVEF <50%.
– Uncontrolled or symptomatic hypercalcemia.
– Grade 2+ peripheral neuropathy
– HIV infection or positive test for HIV antibody.
– Active pulmonary tuberculosis.
– Previous and current pneumonia, pneumoconiosis, radiation pneumonitis or impaired pulmonary function that, in the opinion of the physician, may interfere with detection and management of study drug-related pulmonary side effects.
– Hepatitis B or C infection.
– Known active or suspected autoimmune diseases. Patients that are stable and that do not need immunosuppressant therapy are allowed to enroll.
– Treatment with live vaccines, COVID-19 vaccine, within 28-days prior to study drug administration. Inactivated viral vaccines for seasonal flu are allowed.
– Patients that are requiring treatment with systemic corticosteroids or other immunosuppressive drugs within 14 days prior to first dose. (Subjects are allowed to use topical or inhaled steroids, and adrenal hormone replacement therapy at less than or equal to 10mg/day of prednisone or similar).
– Active infection requiring systemic therapy within 14 days prior to study drug administration. Patients with history of Covid-19 infection must have negative PCR test prior to first dose of study drug.
– Major surgery within 28 days or radiation within 3 months prior to study start.
– Patient has previously received other immune-checkpoint inhibitors such as PD-1, PD-L1, CTLA4.
– Is currently participating in another ongoing clinical trial or is less than 14 days from the end of a previous clinical trial treatment.
– Has known history of allergy to any monoclonal antibody, or known hypersensitivity to carboplatin or etoposide.
– Additional criteria may apply, and will be discussed with the physician and study team.
Study Contact:
Lisa Wahowske, RN, BSN, OCN
(651) 254-1517
lisa.wahowske@parknicollet.com
SUNRAY-01: A Study of LY3537982 Plus Immunotherapy With or Without Chemotherapy in Participants With Non-Small Cell Lung Cancer (NSCLC) With a Change in a Gene Called KRAS G12C
Principal Investigator: Kurt Demel, MD
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
