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New treatment option for Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Official title Iadademstat + SBRT With Atezo in ES-SCLC
ClinicalTrials.gov ID: NCT07113691
What this study is testing
What is Iadademstat?
Iadademstat is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for extensive stage small cell lung cancer (es-sclc).
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 a phase 1b dose escalation, open-label, non-randomized study of participants with residual, progressive or recurrent ES-SCLC who previously received platinum-based chemotherapy with or without immune checkpoint inhibitor therapy; participants who have achieved only stable disease at the completion of initial platinum-based treatment are eligible for enrollment.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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. Healthy volunteers may be eligible.
You may be able to join if
- Signed informed consent form.
- Ability to comply with protocol, in the treating investigator's judgment.
- Age 18 years or older.
- Participant must have a body weight of at least 50 Kg.
- Histologically documented ES-SCLC previously treated with at least one regimen, including a platinum containing chemotherapy regimen, with...
You likely can't join if
- History of leptomeningeal disease.
- Untreated symptomatic CNS metastases. Participants with asymptomatic CNS metastases are eligible. Participant with treated symptomatic brain...
- Completed stereotactic radiosurgery at least seven days prior to Cycle 1, Day 1 or completed whole brain radiation at least two weeks prior to Cycle...
- No evidence of interim progression between the completion of CNS-directed therapy and the start of trial therapy.
- Ongoing steroid requirement of \<10 mg of prednisone per day (or equivalent) as therapy for CNS disease; anticonvulsants are allowed.
- The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.
See the full eligibility criteria
Who can join
- Signed informed consent form.
- Ability to comply with protocol, in the treating investigator's judgment.
- Age 18 years or older.
- Participant must have a body weight of at least 50 Kg.
- Histologically documented ES-SCLC previously treated with at least one regimen, including a platinum containing chemotherapy regimen, with progression of disease on or after their most recent therapy or achieving only...
- Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, antiPD-1, and anti-PD-L1 therapeutic antibodies is allowed.
- ECOG performance status of 0 to 2.
- At least one identified tumor lesion to be treated with SBRT.
- At least one additional tumor lesion, separate from the site of SBRT, preferably outside of the 5Gy isodose line, amenable to incisional, excisional, core or forceps (transbronchial) biopsy. Participants must be willing...
- If the initial biopsy is excisional, the excised tumor cannot be counted as a biopsy target lesion and there must be another lesion amenable to incisional, excisional, core or forceps biopsy. In this scenario, the...
- Cytology tumor specimens (e.g., from fine-needle biopsies, or drainage of pleural/ pericardial or ascites fluid) are not acceptable. Biopsies of bone lesions that do not have a soft tissue component are also not...
- If enrolled with stable, but not progressive, disease at the completion of first line platinum-based therapy regimen, participants may undergo biopsy of the same site that is to be irradiated. If a separate site is...
- Participants must agree to submit blood samples for exploratory biomarker research at the times identified in the study calendar.
- Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be counted as target lesions if clearly progressing after radiation.
- Participants may have asymptomatic CNS metastases or treated CNS metastases if they are not currently receiving corticosteroids equal to or greater than prednisone 10 mg daily or equivalent for seven days prior to the...
- Participants with new asymptomatic CNS metastases detected on their screening scan will undergo repeat CNS imaging at four weeks to ensure safety.
- Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage from CNS disease.
- Metastases are limited to the cerebellum and supratentorial region (i.e. no metastases to the midbrain, pons, medulla or spinal cord).
- Prior palliative radiotherapy must have been completed at least 1 week before the first dose of the study drug.
- Anticonvulsants are allowed.
- Participants must adhere to the following reproductive and contraceptive requirements while on study treatment and for at least five months after the last dose of the study drugs.
What rules you out
- History of leptomeningeal disease.
- Untreated symptomatic CNS metastases. Participants with asymptomatic CNS metastases are eligible. Participant with treated symptomatic brain metastases is eligible provided they meet all of the following criteria:
- Completed stereotactic radiosurgery at least seven days prior to Cycle 1, Day 1 or completed whole brain radiation at least two weeks prior to Cycle 1, Day 1.
- No evidence of interim progression between the completion of CNS-directed therapy and the start of trial therapy.
- Ongoing steroid requirement of \<10 mg of prednisone per day (or equivalent) as therapy for CNS disease; anticonvulsants are allowed.
- The participant has no history of intracranial hemorrhage or spinal cord hemorrhage.
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for more than or equal...
- Uncontrolled tumor-related pain.
- Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Participants should be recovered from the effects of...
- Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be...
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) a. Participants with indwelling catheters (e.g., PleurX) are allowed.
- Uncontrolled or symptomatic hypercalcemia (ionized calcium greater than 1.5 mmol/L, calcium greater than 12 mg/dL or corrected serum calcium greater than ULN)
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel...
- Participants with a history of autoimmune related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
- Participants with controlled type 1 diabetes mellitus and are on an insulin regimen will be eligible for the study.
- Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of the...
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed...
- Active tuberculosis.
- Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within three months prior to initiation of study treatment...
- Major surgical procedure, other than for diagnosis, within four weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study.
- History of malignancy within one year prior to screening (other than SCLC), with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate greater than 90%), such as adequately...
- Severe infection within four weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection or bacteremia. a. Participant has evidence of active uncontrolled...
- Treatment with therapeutic oral or IV antibiotics within two weeks prior to initiation of study treatment. a. Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic...
- Prior allogeneic stem cell or solid organ transplantation.
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render...
- Treatment with a live, attenuated vaccine within four weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab or iadademstat treatment or within five months after the...
- Current treatment with anti-viral therapy for HBV.
- Treatment with investigational therapy within 28 days prior to initiation of study treatment.
- Any approved systemic anti-cancer treatment within three weeks prior to initiation of study treatment.
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2, IL-2) within four weeks or five half-lives of the drug (whichever is longer) prior to initiation of study...
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antiTNFagents) within 2 weeks prior to initiation of...
- Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible...
- Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal...
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
- Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation.
- Known allergy or hypersensitivity to any component of the iadademstat formulation.
- Malabsorption syndrome or other conditions that would interfere with enteral absorption.
- Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within five months after the final dose of study treatment.
- Known infection with HIV, HBV or HCV. Participants with prior exposure to hepatitis virus, but no evidence of active or chronic infection, may be eligible.
- Evidence of end-organ damage as defined by the following laboratory results obtained within 14 days prior to the first study treatment:
- ANC \<1,500 cells/µL (without granulocyte colony stimulating factor support within 14 days prior to Cycle 1, Day 1).
- Platelet count \<100,000/µL (without transfusion within 14 days prior to Cycle 1, Day 1).
- Lymphocyte count less than or equal to 0.5 x10\^9/L.
- Hemoglobin \<9.0 g/dL (Participants may be transfused to meet this criterion).
- AST, ALT, and ALP \>2.5 x ULN, with the following exceptions: Participants with documented liver metastases: AST and/or ALT \>5 x ULN. Participants with documented liver or bone metastases: ALP \>5 x ULN.
- Serum bilirubin \>1.5 x ULN (Participants with known Gilbert disease who have serum bilirubin level \<3 x ULN may be enrolled).
- CrCl \< 40mL/min (Cockcroft-Gault formula).
- INR and aPTT \>1.5 x ULN. a. This applies only to participants who are not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation are allowed.
- Participants with uncontrolled hypertension (i.e., systolic blood pressure \>180 mm Hg, diastolic blood pressure \> 95 mm Hg). Use of anti-hypertensive agents to control hypertension before Cycle1 Day 1 is allowed.
- Participants receiving antidepressants reported to have KDM1A/LSD1 inhibitory activity: Tranylcypromine or Phenelzine.
- Participants who have not recovered from grade ≥2 AEs due to prior anti-cancer therapy with the exception of alopecia, and vitiligo.
- Participants with grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the sponsor-investigator.
- Participants with history of clinically significant bleeding, specifically any history of intracranial hemorrhage / hemorrhagic cardiovascular accident (CVA), or participants with gastrointestinal bleeding within the 3...
- Participants with uncontrolled disseminated intravascular coagulation.
- Participants who refuse or are unable to potentially receive blood products.
- Participants should be carefully questioned regarding their history of acquired or congenital immune deficiencies or autoimmune disease. Participants with any history of immune deficiencies or autoimmune disease listed...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, 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. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, 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.