BridgeMD
New treatment option for Non Small Cell Lung Cancer
Official title EZH2 Inhibitor, Tulmimetostat, and PD-1 Blockade for Treatment of Advanced Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT05467748
What this study is testing
What is Tulmimetostat?
Tulmimetostat is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for non small cell lung cancer.
Also referred to as Pembrolizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open label, single arm, phase Ib/II clinical trial of checkpoint blockade, pembrolizumab and EZH2 inhibitor, tulmimetostat combination therapy for patients with advanced non-small cell lung cancer who have progressed from front or second-line treatment. Patients will be enrolled at multiple Veterans Affairs Medical Centers.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provide written informed consent/assent for the trial. The trial consent includes future biomedical research.
- Male/female participants who are at least 18 years of age on the day of signing informed consent
- Patients with histologically confirmed diagnosis of advanced non-small cell lung cancer.
- Have a life expectancy of 12 weeks
- Participants who progressed from chemo(platinum-based)-immunotherapy, immunotherapy single agent or immuno-immuno combination therapies as front or...
You likely can't join if
- Primary diagnosis of low to intermediate grade of neuroendocrine lung cancer.
- Clinically active cerebral metastases. Patients with a prior diagnosis of cerebral metastases may be enrolled, provided that lesions have been...
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks prior to study enrollment. Note: Participants...
- Prior exposure to tulmimetostat or other EZH2 inhibitors.
- EGFR or ALK altered patients.
- Immunotherapy naïve patients.
See the full eligibility criteria
Who can join
- Provide written informed consent/assent for the trial. The trial consent includes future biomedical research.
- Male/female participants who are at least 18 years of age on the day of signing informed consent
- Patients with histologically confirmed diagnosis of advanced non-small cell lung cancer.
- Have a life expectancy of 12 weeks
- Participants who progressed from chemo(platinum-based)-immunotherapy, immunotherapy single agent or immuno-immuno combination therapies as front or second line of therapy.
- Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by...
- Has received at least 2 doses of an approved anti-PD-1/L1 mAb.
- Has demonstrated disease progression after anti-PD-1/L1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease...
- Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1/L1 mAb.
- Progressive disease is determined according to RECISTv1.1.
- This determination is made by the investigator. Once disease progression is confirmed, the initial date of disease progression documentation will be considered the date of disease progression.
- Have measurable disease per RECIST v1.1 as assessed by the investigator and site radiologist.
- Have provided archival tumor sample or newly obtained core or excisional biopsy of tumor lesion. Formalin fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides and the pretreatment biopsy is...
- Adequate organ function. (must be within 10 days prior to start of study intervention)
- Absolute neutrophil counts (ANC) 1500/mm3
- Platelet count 100,000/mm3
- Hemoglobin 9 g/dL without need for hematopoietic growth factor or transfusion support.
- Serum creatinine 1.5 x ULN (Upper Limit of Normal), or 24-hour creatinine clearance 30 cc/min. (note: creatinine clearance need not be determined if the baseline serum creatinine is within normal limits)
- Serum bilirubin 1.5 ×ULN OR direct bilirubin ULN for participants with total bilirubin levels \>1.5 × ULN.
- Aspartate amino transferase (AST) 2.5 ULN or 5XULN for people with liver metastases.
- Alanine amino transferase (ALT) 2.5 ULN or 5XULN for people with liver metastases.
- Alkaline phosphatase 2.5 X ULN of liver fraction if 2.5 X ULN
- Serum albumin 2.5g/dL.
- Prothrombin time (PT) 1.5 x ULN and INR 1.3
- Partial thromboplastin time (PTT) 1.5 ULN.
- ECOG 0-1.
- Allowing patients who received over 30 Gy radiation therapy within 6 months of pembrolizumab treatment given the safety data from stage III patient received immunotherapy after concurrent chemotherapy and radiation.
- Female people of childbearing/reproductive potential must have a negative serum pregnancy test within 72 hours prior to receiving the treatment of study medication.
- Female people of childbearing potential and their partners must be willing to use a highly effective method of contraception as outlined in 5.5.2- Contraception, for the course of study through 183 days after the last...
- Male people and their partners of childbearing potential must agree to use a highly effective method of contraception as outlined in 5.5.2- Contraception, starting with the first dose of study medication through 183...
What rules you out
- Primary diagnosis of low to intermediate grade of neuroendocrine lung cancer.
- Clinically active cerebral metastases. Patients with a prior diagnosis of cerebral metastases may be enrolled, provided that lesions have been adequately treated with radiation therapy or surgery, and have not required...
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks prior to study enrollment. Note: Participants who have entered the follow-up phase of an investigational study may...
- Prior exposure to tulmimetostat or other EZH2 inhibitors.
- EGFR or ALK altered patients.
- Immunotherapy naïve patients.
- Has a history of severe hypersensitivity reaction to pembrolizumab ( Grade 3).
- Has an active autoimmune disease that requires systemic treatment within the past 2 years or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic immunosuppressive agents...
- Patient is positive for Human Immunodeficiency Virus (HIV) (HIV 1 2 antibodies), active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA is detected); patients with negative Hepatitis C antibody testing may not need...
- History of non-infectious pneumonitis that required steroids or current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has received a live virus vaccine or live-attenuated within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
- people taking medications that are known as strong CYP3A4 inducers/inhibitors. (examples of inducers: not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort; examples of...
- Has not fully recovered from any effects of major surgery without significant detectable infection. Surgeries that required general anesthesia or major surgeries must be completed at least 4 weeks before first study...
- Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis...
- Had administered concomitant medication(s) or food or beverage that are strong CYP3A inducers or inhibitors within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 year. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ...
- Inability to take oral medication or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of tulmimetostat.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or...
- Venous thromboembolism or pulmonary embolism within the last 3 months before starting study medication.
- people who undergone an allogenic tissue/solid organ transplantation.
- A WOCBP who has a positive serum pregnancy test within 72 hours prior to study treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Pregnant female people or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 183 days after the last dose of study treatment.
- Patient is, at the time of signing consent, current use of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)
- Has known psychiatric disorders that would interfere with cooperation with the requirement of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Long Beach, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Ann Arbor, Michigan, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Long Beach, California, United States; Sacramento, California, United States; San Diego, California, United States; Ann Arbor, Michigan, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.