Testing the Combination of an Anti-cancer Drug, Iadademstat, With Other Anti-cancer Drugs (Atezolizumab or Durvalumab) at Improving Outcomes for Small Cell Lung Cancer
- Conditions
- Extensive Stage Lung Small Cell CarcinomaStage IV Lung Cancer AJCC v8
- Registration Number
- NCT06287775
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria:<br><br> - Patients must have histologically or cytologically confirmed small cell lung cancer<br> (SCLC)<br><br> - Patients must have measurable disease, defined as at least one lesion that can be<br> accurately measured in at least one dimension (longest diameter to be recorded for<br> non-nodal lesions) as = 20 mm (= 2 cm) by chest x-ray or as = 10 mm (= 1 cm) with CT<br> scan, MRI, or calipers by clinical exam or the shortest axis for nodal lesions as =<br> 15 mm (= 1.5 cm) with CT scan<br><br> - Patients who have been treated with platinum etoposide chemotherapy plus either<br> atezolizumab or durvalumab immunotherapy for 4 cycles with either a radiographic<br> response or stable disease<br><br> - Age = 18 years. Because no dosing or adverse event data are currently available on<br> the use of iadademstat in combination with atezolizumab and durvalumab in patients<br> <18 years of age, children are excluded from this study<br><br> - Body weight = 50 kg<br><br> - Patient is able to swallow oral medications<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status = 2 (Karnofsky = 60%).<br> This assessment for eligibility will take place after patients have received 4<br> cycles of standard of care (SOC) chemotherapy-ICI<br><br> - Leukocytes = 2,000/mcL<br><br> - Lymphocyte count = 500/mcL<br><br> - Absolute neutrophil count = 1,500/mcL<br><br> - Hemoglobin = 9 g/dL<br><br> - Platelets = 100,000/mcL<br><br> - Albumin = 3 g/dL<br><br> - Total bilirubin = 1.5 institutional upper limit of normal (ULN)<br><br> - Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/<br> alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) = 3 ×<br> institutional ULN unless liver metastases are present, in which case it must be = 5<br> × ULN<br><br> - Glomerular filtration rate (GFR) = 60 mL/min/1.73 m^2 using Chronic Kidney Disease<br> Epidemiology Collaboration (CKD-epi) equation<br><br> - Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral<br> therapy with undetectable viral load within 6 months are eligible for this trial<br><br> - For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV<br> viral load must be undetectable on suppressive therapy, if indicated<br><br> - Patients with a history of hepatitis C virus (HCV) infection must have been treated<br> and cured. For patients with HCV infection who are currently on treatment, they are<br> eligible if they have an undetectable HCV viral load<br><br> - Patients with treated brain metastases are eligible if follow-up brain imaging after<br> central nervous system (CNS)-directed therapy shows no evidence of progression<br><br> - Patients with a prior or concurrent malignancy whose natural history or treatment<br> does not have the potential to interfere with the safety or efficacy assessment of<br> the investigational regimen are eligible for this trial<br><br> - Evidence of post-menopausal status or negative urinary or serum pregnancy test for<br> female pre-menopausal patients. Pregnant women are excluded from this study because<br> atezolizumab and durvalumab are monoclonal antibody agents with the potential for<br> teratogenic or abortifacient effects. Women will be considered post-menopausal if<br> they have been amenorrheic for 12 months without an alternative medical cause. The<br> following age-specific requirements apply:<br><br> - Women < 50 years of age would be considered post-menopausal if they have been<br> amenorrheic for 12 months or more following cessation of exogenous hormonal<br> treatments and if they have luteinizing hormone and follicle-stimulating<br> hormone levels in the post-menopausal range for the institution or underwent<br> surgical sterilization (bilateral oophorectomy or hysterectomy).<br><br> - Women = 50 years of age would be considered post-menopausal if they have been<br> amenorrheic for 12 months or more following cessation of all exogenous hormonal<br> treatments, had radiation-induced menopause with last menses >1 year ago, had<br> chemotherapy-induced menopause with last menses > 1 year ago, or underwent<br> surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or<br> hysterectomy)<br><br> - The effects of iadademstat, atezolizumab, and durvalumab on the developing human<br> fetus are unknown. For this reason and because monoclonal antibody agents are known<br> to be teratogenic, women of child-bearing potential and males with females of<br> child-bearing potential must agree to use adequate contraception (hormonal or<br> barrier method of birth control; abstinence) prior to study entry, for the duration<br> of study participation, and for 150 days after the last dose of study medication.<br> Should a woman become pregnant or suspect she is pregnant while she or her partner<br> is participating in this study, she should inform her treating physician<br> immediately.<br><br> - Females of childbearing potential must agree to:<br><br> - Use effective contraception during the trial and 150 days after the end of<br> treatment.<br><br> - Practice true abstinence during the trial and 150 days after the end of<br> treatment.<br><br> - Have a negative urine pregnancy test at screening.<br><br> - Not to donate or freeze egg(s) during the course of this study or within<br> 150 days after receiving their last dose of study drug.<br><br> - Male patients even if surgically sterilized (i.e., status post-vasectomy) must<br> agree to:<br><br> - Use effective contraception during the entire study treatment period and<br> through 150 days after the last dose of study drug.<br><br> - Not to donate or freeze sperm during the course of this study or within<br> 150 days after receiving their last dose of study drug.<br><br> - Because there is an unknown but potential risk for adverse events in nursing infants<br> secondary to treatment of the mother with atezolizumab and durvalumab, female<br> participants who are breastfeeding must agree to discontinue breastfeeding. These<br> potential risks may also apply to iadademstat<br><br> - Ability to understand and the willingness to sign a written informed consent<br> document. Legally authorized representatives may sign and give informed consent on<br> behalf of study participants<br><br>Exclusion Criteria:<br><br> - Patients medicated with anti-depressants reported to have KDM1A/LSD1 inhibitory<br> activity: Tranylcypromine or phenelzine<br><br> - Patients who have not recovered from grade =2 adverse events (AEs) due to prior<br> anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory<br> values defined in the inclusion criteria.<br><br> - Patients with grade = 2 neuropathy will be evaluated on a case-by-case basis<br> after consultation with the study physician<br><br> - Patients who are receiving any other investigational agents or any other agent<br> administered for the treatment of the patient's cancer within four half-lives or 4<br> weeks prior to cycle 1, day 1, whichever is shorter<br><br> - Treatment with systemic immunostimulatory agents (including, but not limited to,<br> interferon [IFN]-a or interleukin [IL]-2) within 4 weeks or five half-lives of the<br> drug (whichever is longer) prior to cycle 1, day 1<b
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Objective response rate;Overall survival;Incidence of adverse events