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
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%)
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).
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
Preserve-003: Phase 3, Two-stage, Randomized Study of ONC-392 Versus Docetaxel in Metastatic Non-Small Cell Lung Cancers that Progressed on PD-1/PD-L1 Inhibitors.
Study sponsor: OncoC4, Inc., BioNTech SE
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: III
Purpose of study: This research study is a Phase 3 clinical trial, which tests the effects of ONC-392 for the treatment of lung cancer compared to a standard of care chemotherapy drug, docetaxel. The most important measurement for the study is to see how long the treatment could prolong your life. ONC-392 is an investigational drug being developed as an anti-tumor treatment.
ONC-392 is an antibody drug that binds to immune cells inside the tumor mass. The target molecule (protein) is called CTLA-4. ONC-392 binds to CTLA-4 and acts to reduce the regulatory immune cells and to let normal immune cells get into the tumor mass to fight against the tumor. ONC-392 has been tested in early Phase 1 and Phase 2 ongoing studies since 2020. This study will enroll participants who have non-small cell lung cancer and have disease progression after platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 based immunotherapy. You will be randomized to receive either ONC-392 or the currently FDA approved standard of care chemotherapy agent docetaxel.
Inclusion Criteria:
– Must be at least 18 years old
– Must have histologically or cytologically confirmed diagnosis of metastatic non small-cell lung cancer (metastasis can be regional lymph nodes or distant organs).
– Progression of disease with most recent line of treatment for 3a or 3b: a) at least 12 weeks of standard dose of PD-1/PD-L1 inhibitor in combination with platinum chemo, b) Prior treatment with at least 2 cycles of platinum chemo followed by 12 weeks of standard PD-1/PD-L1 immunotherapy.
– Must have measurable disease via RECIST 1.1
– Must have ECOG of 0 – 1.
– Must have adequate organ function as determined by local lab tests.
– Must have at least a 3-month life expectancy.
– Sexually active Women of childbearing potential (WOCBP) must agree to highly effective contraceptive use starting at screening and continuing through 90 days after last dose of study drug.
– Sexually active male patients must agree to highly effective contraceptive methods from screening through 90-days after last dose.
– Must agree to allow study team to access archival tissue/ or treatment tissue from biopsy or surgery.
Exclusion Criteria:
– Any patient that has not recovered to baseline from previous anticancer therapy.
– Any patient currently enrolled in another clinical trial that is testing an investigational drug or device, or an approved systemic therapy that contains anti-PD-1/ anti-PD-L1 within the last 28 days prior to first day of study treatment.
– Patients with chronic steroid therapy of greater than 10mg per day or prednisone or equivalent within 7 days prior to first dose of study drug.
– Patients with documented mutations or genetic alterations in the following genes: EGFR, ROS1, MET, BRAF, RET, NTRK, ALK, or HER2.
– Patients with active of symptomatic brain metastasis or evidence of progression within 4 weeks prior to study drug.
– Patients with active GI disease such as Inflammatory Bowel Disease, diverticulitis, pancreatitis, or peptic ulcer disease, etc are excluded.
– Patients with current, active, or prior history of Interstitial lung disease, or pneumonitis, that required high dose steroids.
Study Contact:
Alissa Gavenda, RN
(952) 993-6705
alissa.gavenda@parknicollet.com
STK-012: A Phase 1a/1b Study to Evaluate the Safety and Tolerability of STK-012 as a Single Agent and in Combination Therapy in Subjects with Selected Advanced Solid Tumors
Study sponsor: Synthekine, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: The purpose of this study is to test the safety and tolerability of the study drug STK-012 as a single drug, or in combination with other therapy. The drug works by helping to trigger the body’s immune system to attack the cancer cells, and destroying the cells so that they can’t multiply and divide.
Inclusion Criteria:
– Must be at least 18 years or older.
– Life expectancy of at least 3 months as determined by the treating physician.
– Must have measurable disease via RECIST 1.1.
– ECOG of 0 – 1.
– Adequate organ function as determined by local lab tests within 28 prior to first dose.
– Female patients of childbearing potential must have a negative serum pregnancy test within 72hrs prior to first dose of study drug, and must also agree to highly effective birth control methods during treatment, and for at least 180 days post last dose unless meeting the following criteria: Over the age of 60, postmenopausal with no menses for 1 year, and confirmed by FSH, history of hysterectomy and/or bilateral oophorectomy, or a history of bilateral tubal ligation.
– Male patients must also agree to highly effective methods of contraception and refrain from donating sperm during treatment, and for 180 days after the last dose.
– Patients must have adequate archival tissue within 24 months of screening. If archival tissue is not available, a fresh biopsy is required (unless deemed unsafe by the treating physician and discussion with the study medical monitor).
– Must have confirmed Stage IV non-squamous non small cell lung cancer.
– Patient’s tumor must be predominantly non-squamous histology. If small cell elements are present, patient will be ineligible.
– Must not have any known actionable gene mutations for which there are approved targeted therapies.
– Subjects in part E can have any level of PD-L1 expression (TPS of 0-100%), subjects in part F must have negative PD-L1 (TPS<1%) per local testing.
– Must not have received prior treatment for advanced NSQ NSCLC (Subjects that received adjuvant, neoadjuvant, or consolidation therapy are eligible for the study if the therapy was completed at least 12 months prior to recurrence or progression).
*Additional inclusion criteria may apply and will be discussed with the physician and research team*
Exclusion Criteria:
– Received systemic anticancer therapy within 3 weeks prior to first dose.
– Received radiation therapy within 2 weeks prior to first dose.
– Received prior treatment with IL-2 or IL-15 based cytokine therapy.
– Has history of pulmonary fibrosis (including pneumonitis), drug or radiation induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT.
– Currently participating in, or has participated in a study of an investigational agent or investigational device within 4 weeks prior to first dose of study drug. Subjects that entered a follow-up phase of an investigational study may participate if at least 4 weeks has passed since the last dose of previous treatment.
– Has received prior therapy with anti-PD1 or anti-PD-L1 agent, or agent directed to other receptors (such as CTLA-4, OX40, or CD137).
– Failure to recover from immune-related adverse event from previous immunotherapy. (Patients with sensory neuropathy, alopecia, or endocrinopathies that are controlled by hormone-replacement therapy, or other grade 2 or less event that in the physician’s opinion does not pose a safety risk to the patient, are eligible).
– Failure to recover from other non-immune-related toxicities from prior therapy to at least grade 2 or less.
– Known active brain mets. Patients with treated brain mets may be eligible if they are clinically stale and without need of steroid treatment for at least 14 days prior to first dose of study drug.
– Hypersensitivity of Grade 3 or higher to monoclonal antibodies, including pembrolizumab or any of its excipients.
– Known history or, or active autoimmune disease or syndrome that requires steroids or immunosuppressive agents. (patients with Vitiligo, type 1 diabetes mellitus, resolved childhood asthma, hypo- or hyperthyroidism due to autoimmune condition that doesn’t require immunosuppressive treatment, psoriasis, atopic dermatitis, or other skin condition that is managed without systemic therapy, or arthritis that is managed without systemic therapy beyond oral acetaminophen and NSAIDs are allowed).
– History of allogenic/solid tissue organ transplant.
– Clinically significant cardiovascular disease or risk factors at screening that include the following: cerebral vascular accident/stroke, or myocardial infarction, unstable angina, congestive heart failure (>/=NYHA class 2), or serious cardiac arrhythmia requiring medication. QTcF>470 on screening ECG, or congenital long QT syndrome. TdP, including hypokalemia or hypomagnesemia, history of significant or symptomatic bradycardia. Family history of sudden death or congenital long QT syndrome. Concomitant medications with known risk of Torsades De Pointe that cannot be discontinued or replaced with safe alternative within 6 half-lives before first dose of study drug.
– History of other clinically unstable/uncontrolled disorder, condition, or disease, that in the opinion of the physician, would pose a risk to patient safety, or interfere with the study evaluations, procedures, or completion.
– Serious active bacterial, viral, parasitic, or systemic fungal infections requiring systemic treatment within 30 days prior to first dose of study drug.
– Known additional malignancy that is progressing, or has required active treatment within the last 2 years (Patients with basal cell, squamous cell skin cancer, or carcinoma in situ that has undergone curative therapy are not excluded from being able to participate in the study).
– Has received a live-virus vaccine within the last 30 days prior to first dose of study drug (Seasonal flu and covid-19 vaccines that do not include live virus are permitted).
– Known history of testing positive for HIV or AIDS, or testing positive for HIV by positive serum HIV test at screening.
– Active hepatitis B or C infection at screening as confirmed by local lab tests.
– Pregnant, breastfeeding, expecting to conceive, or to father children within the duration of the study, starting at screening and through 180 days after the last dose of study drug.
*Additional criteria may apply and will be discussed with the physician and research team*
Study Contact:
Lisa Wahowske
(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
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
