A First-in-Human, Open-Label, Dose Escalation and Expansion Study of Orally Administered NX-019 in Patients with Advanced, EGFR Mutant Cancer
Principal Investigator: Rachel Lerner, MD
Study sponsor: Nalo Therapeutics
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: This is a two-part study looking at the safety, tolerability, and preliminary efficacy of study drug NX-019 in patients with non small cell lung cancer with EGFR mutation.
Part 1: The primary objective of Part 1 of this study is to evaluate the safety and tolerability of NX-019 and to determine the maximum tolerated dose (MTD).
Part 2: The primary objective of Part 2 of this study is to confirm the safety and tolerability of NX-019 at the recommended dose for specific cohorts, and to measure the objective response rate.
Inclusion Criteria:
– Be at least 18 years or older at time of consent.
– Confirmed locally advanced or metastatic EGFR-mutant non small cell lung cancer.
– Patients with NSCLC that have a mutation that is sensitive to Osimertinib.
– Measurable disease based on RECIST 1.1.
– expected life expectancy of 3 months.
– adequate organ and bone function as determined by lab tests.
– Must receive baseline MRI.
– Side effects from prior therapies must be at grade 1 or 0 prior to study start.
– ECOG of 0 – 2.
– Negative serum pregnancy within 72hrs prior to first dose.
– Willingness to utilize conventional highly contraceptive methods for both participant and partner.
The following are cohort specific inclusion criteria for Part 2:
Cohort 1:
-NSCLC w/ EGFR exon 19 deletions, or exon 21 L858R mutations who progressed on EGFR TKI therapy.
Cohort 2:
– NSCLC with EGFR ex20ins mutation, who are not suitable for, or are unwilling to receive available targeted therapy for ex20ins mutations.
Cohort 3:
– NSCLC with EGFR mutations for which there is no targeted therapy available (excluding exon 19, exon 21 L858R, and ex20ins).
*Additional criteria may apply and will be discussed with the study physician and study team.
Exclusion Criteria:
– Known C797X EGFR mutation, or 1 or more known secondary drivers of disease.
– Disease requiring immediate treatment with surgery or radiation.
– Is taking 4mg/day or more of dexamethasone (or equivalent) for managing brain metastasis.
– Received anticancer treatment within 2 weeks prior to study start.
– Had major surgery within 3 weeks prior to study start.
– Received radiation within 4 weeks prior to study start.
– Unstable severe cardiac condition within 6 months prior to study start.
– Uncontrolled or unstable diabetes or psychiatric condition.
– Is dependent on contact lenses (cannot wear glasses).
– History or lung disease requiring systemic steroid therapy, or other significant lung disease.
– Other active malignancy within 2 years or has active infection requiring therapy
– Known immunodeficiency virus, Hepatitis B or C.
– Active GI disease such as Crohn’s disease, ulcerative colitis, or other conditions that can impact drug absorption.
– Pregnant or breastfeeding
– currently using a proton pump inhibitor and cannot refrain from use for 7 days prior to study start.
– Is currently on a strong CYP3A inhibitor or inducer, and cannot refrain from use for 7 days prior to study start.
– Any other condition that, in the opinion of the physician, would impact the patient’s ability to take part in the trial.
*Additional exclusion criteria may apply and will be discussed with the physician and the study team.
Study Contact:
Alissa Gavenda, RN
(952) 993-6705
[email protected]
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
[email protected]
AK112-301: A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined with Pemetrexed and Carboplatin in Patients with EGFRmutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment (HARMONi).
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 study is randomized, meaning you have an equal chance to be placed in either the study drug arm, or the placebo arm. The study is split into two arms: Arm 1 is the study drug (Ivonescimab, or AK112) combined with the drugs Pemetrexed and Carboplatin. Arm 2 is Placebo combined with Pemetrexed and Carboplatin. Since both arms are receiving Pemetrexed and Carboplatin, you will still be receiving some form of treatment for your disease regardless of what arm you are assigned. The main purpose of the study is to compare the overall survival and progression-free survival between the two arms. The study drug is an antibody. Antibodies are substances that occur naturally in the body and help fight infection. The study drug blocks two proteins in the body that help cancer cells live, grow, and spread. It is possible that the study drug may slow the growth and spread of cancer cells.
Inclusion Criteria:
– Must sign written informed consent.
– Must be at least 18 years old at the time of consent.
– ECOG of 0 – 1.
– Expected survival of at least 3 months.
– Confirmed locally advanced (stage IIIB / IIIC) or metastatic (stage IV) non-squamous non-small cell lung cancer.
– EGFR mutation as confirmed by tumor testing.
– Prior treatment with EGFR TKIs and treatment failure.
– At least 1 measurable noncerebral lesion per RECIST 1.1.
– Adequate organ function as determined by local lab tests.
– Negative serum pregnancy test within 3 days prior to first dose for women of child-bearing potential (WOCBP).
– WOCBP and their partners must agree to highly effective contraceptive use during the duration of the study and for at least 120 days following the last dose.
– Additional criteria may apply and will be discussed with the physician and research team.
Additional inclusion criteria may apply and will be discussed in greater detail with research team and physician.
Exclusion Criteria:
– Evidence of small cell carcinoma component, or predominantly squamous cell carcinoma.
– Previously received immunotherapy including anti-PD-1/PD-L1 antibodies, anti-CTLA4, and immune-checkpoint agonists, immune cell therapy.
– Received systemic antitumor therapy or antiangiogenic therapy other than EGFR inhibitors.
– Enrolled in another clinical trial, unless it is a non-interventional study or the follow-up period of an interventional study, and is more than 4 weeks from the last dose of the prior clinical study drug administration.
– Received EGFR inhibitor therapy within 2 weeks prior to first dose.
– Imaging during the screening period showing tumor growth around important blood vessels, that in the physician’s opinion could be a concern for bleeding risks.
– Symptomatic brain metastases.
– Other malignant tumors besides NSCLC within 3 years prior to first dose.
– Active autoimmune disease requiring systemic therapy within 2 prior to first dose. *Replacement therapy such as insulin or corticosteroid replacement therapy (prednisone <10mg per day or equivalent) for adrenal or pituitary insufficiency is allowed.
– History of major diseases within 1 year before first dose
– Major surgical procedures or severe infections within 4 weeks prior to first dose.
– History of severe bleeding.
– Current hypertension, uncontrolled hyperglycemia, presence of pleural effusions, pericardial effusions, ascites requiring multiple drainage, history of noninfectious pneumonia,
– Active or history of IBD (such as Crohn’s disease, ulcerative colitis)
– History of immunodeficiency; HIV test positive.
– History of Allogenic organ transplant or hematopoietic stem cell transplant.
– Untreated Hepatitis B, active Hepatitis C
– Known active tuberculosis
– Active Syphilis
– Unresolved toxicities from previous treatments that have not returned to baseline.
– Other exclusion criteria may apply and will be discussed with the physician and research team.
Study Contact:
Lisa Wahowske, RN, OCN
(651) 254-1517
[email protected]
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
[email protected]
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
[email protected]
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.
Principal Investigator: Dylan Zylla, MD
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
[email protected]