[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extensive-stage-lung-small-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extensive-stage-lung-small-cell-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,41,52,75,102,129,156,177,199,227],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054299","phase-2-testing-the-addition-of-radiation-therapy-to-the-usual-immune-therapy-treatment-atezolizumab-for-extensive-stage-small-cell-lung-cancer-the-raptor-trial-100054299",false,"NCT04402788","Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial","RAndomized Phase II\u002FIII Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial","Inclusion Criteria:\n\n* Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases\n* Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide\u002Fplatinum (E\u002FP) doublet plus atezolizumab by re-staging scans (positron emission tomography \\[PET\\]\u002Fcomputed tomography \\[CT\\] scan, diagnostic CT scan, magnetic resonance imaging \\[MRI\\] optional per treating physician); atezolizumab should continue through randomization. Patients must be randomized within 9 weeks of last dose of etoposide\u002Fplatinum (if not receiving PCI) or 6 weeks from completion of prophylactic cranial irradiation (PCI)\n\n  * NOTE: Patients must have at least 3 cycles of E\u002FP plus atezolizumab. They can have one cycle of induction E\u002FP without concurrent atezolizumab if unable to receive concurrent E\u002FP combined with atezolizumab for all cycles of induction therapy\n* Patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors \\[RECIST\\]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment\n* At time of enrollment after induction E\u002FP chemotherapy and atezolizumab, if there is a pleural effusion, patients will be eligible if thoracentesis is cytologically negative or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT\u002FPET imaging\n* Appropriate stage for study entry based on the following diagnostic workup:\n\n  * History\u002Fphysical examination within 14 days prior to registration;\n  * Imaging within 42 days prior to registration to include:\n\n    * MRI brain with contrast or CT brain with contrast\n    * CT chest, abdomen and pelvis or whole body PET\u002FCT scan any time after the fourth cycle of chemotherapy and prior to registration\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1,000\u002Fcells\u002Fmm\\^3 (within 14 days prior to registration)\n* Platelets \\>= 75,000 cells\u002Fmm\\^3 (within 14 days prior to registration)\n* Hemoglobin \\>= 8 g\u002FdL (within 14 days prior to registration)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x ULN (AST and\u002For ALT =\\\u003C 5 ULN for patients with liver involvement) (within 14 days prior to registration)\n* Alkaline phosphatase =\\\u003C 2.5 x ULN (=\\\u003C 5 ULN for patients with documented liver involvement or bone metastases) (within 14 days prior to registration)\n* Adequate renal function = Creatinine clearance \\>=40 mL\u002Fmin by the Cockcroft-Gault (C-G) equation: (within 14 days prior to registration)\n* Upfront radiation therapy of symptomatic metastatic site is permissible if causing symptoms such as pain or impending fracture\n* Patients with brain metastases are eligible after receiving whole brain radiation before enrollment (anytime during induction systemic therapy). Whole brain radiation can be delivered with hippocampal sparing or 3-D conformal technique. Patients with irradiated brain metastases are eligible if they are clinically stable from a neurological standpoint after completing radiotherapy (e.g. not having uncontrolled seizures) and do not require use of steroids above a dose of 10 mg of prednisone daily\n* For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to registration.\n\n  * Note: Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n    * Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)\n    * Women \\>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\> 1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)\n* Patients positive for human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months and a stable regimen of highly active anti-retroviral (HAART) HIV-positive patients must have no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n\nExclusion Criteria:\n\n* Metastatic disease invading the liver (\\> 3 metastases), heart or \\> 10 metastatic sites detectable after induction systemic therapy. Each visible bone metastasis on radiographic scan counts as one site\n* Patients with a concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen with atezolizumab or radiation\n* Prior radiotherapy in the thorax that would result in overlapping RT fields, unless the overlapping fields meet acceptable dose constraints for normal tissue\n* Active autoimmune disease, including, but not limited to: systemic lupus erythematosus; rheumatoid arthritis; inflammatory bowel disease (e.g. Crohn's, ulcerative colitis); vascular thrombosis associated with antiphospholipid syndrome; Wegener's granulomatosis; Sjogren's syndrome; Guillain-Barre syndrome; multiple sclerosis; vasculitis; or glomerulonephritis.\n\n  * If the autoimmune disease is not active for over 3 years and the patient is not receiving immunosuppressive treatment such as methotrexate or steroids above a dose equivalent to 10 mg prednisone daily, the patient is eligible.\n  * Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible\n  * Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible\n  * Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations are excluded only if they have active disease with acute exacerbation and on immunosuppressive medications within the 12 months prior to enrollment. They are eligible otherwise.\n* Severe, active co-morbidity defined as follows:\n\n  * Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;\n  * Active tuberculosis;\n  * Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease\n\n    * Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive anti-HBc \\[antibody to hepatitis B core antigen\\] antibody test) are eligible\n    * Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test)\n  * Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL);\n  * Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of \\> 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary;\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 3 months;\n  * History of recent myocardial infarction within 6 months prior to registration.\n  * Clinically significant interstitial lung disease\n* Pregnancy: Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Women who are breastfeeding and unwilling to discontinue\n* History of allogeneic organ transplant\n* Patients who have had immunotherapy-induced pneumonitis","ALL","18 Years",{"count":19,"type":20},138,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This phase II\u002FIII trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.",[27],"Extensive Stage Lung Small Cell Carcinoma","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2021-01-07",{"date":36,"type":20},"2027-04-30",{"name":38,"class":39},"National Cancer Institute (NCI)","NIH",416,{"id":42,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":43,"targetDuration":4,"studyType":21,"phases":44,"briefSummary":25,"conditions":45,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":49,"completionDateStruct":50,"leadSponsor":51,"locationsCount":40},"100393420",{"count":19,"type":20},[23,24],[27],"2026-07-01",{"date":48,"type":32},"2026-07-02",{"date":34,"type":32},{"date":36,"type":20},{"name":38,"class":39},{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100538203","phase-1-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-100538203","NCT06287775","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","A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed small cell lung cancer (SCLC)\n* Patients who have been treated with platinum etoposide chemotherapy plus either atezolizumab or durvalumab immunotherapy for at least 4 cycles, and no more than 6 cycles, with either a radiographic response or stable disease. Patients are eligible if a maximum of 2 cycles of atezolizumab or durvalumab were omitted with initial treatment\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of iadademstat in combination with atezolizumab and durvalumab in patients \\\u003C18 years of age, children are excluded from this study\n* Body weight ≥ 50 kg\n* Patient is able to swallow oral medications\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%). This assessment for eligibility will take place after patients have received 4 cycles of standard of care (SOC) chemotherapy-ICI\n* Leukocytes ≥ 2,000\u002FmcL\n* Lymphocyte count ≥ 500\u002FmcL\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Hemoglobin ≥ 9 g\u002FdL\n* Platelets ≥ 100,000\u002FmcL\n* Albumin ≥ 3 g\u002FdL\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN unless liver metastases are present, in which case it must be ≤ 5 × ULN\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases (no escalating steroid use) or asymptomatic, untreated brain metastases (≤ 5 mm without significant edema) are eligible. Brain metastases must not be new after completion of chemotherapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Pregnant women are excluded from this study because atezolizumab and durvalumab are monoclonal antibody agents with the potential for teratogenic or abortifacient effects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)\n* The effects of iadademstat, atezolizumab, and durvalumab on the developing human fetus are unknown. For this reason and because monoclonal antibody agents are known to be teratogenic, women of child-bearing potential and males with females of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to registration, for the duration of study participation, and for 150 days after the last dose of study medication. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n  * Females of childbearing potential must agree to:\n\n    * Use effective contraception during the trial and 150 days after the end of treatment.\n    * Practice true abstinence during the trial and 150 days after the end of treatment.\n    * Have a negative urine pregnancy test at screening.\n    * Not to donate or freeze egg(s) during the course of this study or within 150 days after receiving their last dose of study drug.\n  * Male patients even if surgically sterilized (i.e., status post-vasectomy) must agree to:\n\n    * Use effective contraception during the entire study treatment period and through 150 days after the last dose of study drug.\n    * Not to donate or freeze sperm during the course of this study or within 150 days after receiving their last dose of study drug.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with atezolizumab and durvalumab, female participants who are breastfeeding must agree to discontinue breastfeeding. These potential risks may also apply to iadademstat\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who receive maintenance ICI therapy prior to cycle 1, day 1\n* Patients medicated with anti-depressants reported to have KDM1A\u002FLSD1 inhibitory activity: Tranylcypromine or phenelzine\n* Patients who have not recovered from grade ≥2 adverse events (AEs) due to prior anti-cancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n\n  * Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the study physician\n* Patients who are receiving any other investigational agents or any other agent administered for the treatment of the patient's cancer within four half-lives or 4 weeks prior to registration, whichever is shorter\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon \\[IFN\\]-α or interleukin \\[IL\\]-2) within 4 weeks or five half-lives of the drug (whichever is longer) prior to cycle 1, day 1\n* Treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] agents) within 2 weeks prior to registration or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Patients who have received acute, low dose, systemic immunosuppressant medications or one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible after Principal Investigator confirmation has been obtained.\n  * Patients who have received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenocortical insufficiency are eligible\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to iadademstat, atezolizumab, or durvalumab. In particular, a history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric antibodies, fusion proteins, or Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Atezolizumab Concomitant Medication Considerations: Patients are not allowed to receive immunostimulatory agents, immunosuppressive medications, or herbal and natural remedies\n* Durvalumab Concomitant Medication Considerations: Patients are not allowed to receive immunosuppressive medications, EGFR TKIs, or herbal and natural remedies\n* Iadademstat Concomitant Medication Considerations: Patients are not allowed to receive prophylactic hematopoietic colony stimulating factors, any complementary or alternative medicine \\[any of various systems of healing or treating disease (as non-prescription drugs, herbal medicine and homeopathy)\\]. Use of these types of treatments must be terminated 1 week prior to registration\n* History of allogenic organ transplantation\n* Patients with active tuberculosis (TB)\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Unstable angina, symptomatic or otherwise uncontrolled arrhythmia (does not include stable, lone atrial fibrillation), Fridericia's correction (QTcF) \\> 480 ms based on screening electrocardiogram (ECG), myocardial infarction ≤ 3 months prior to registration, cerebrovascular accidents ≤ 3 months before registration. Patient has congestive heart failure New York Heart Association (NYHA) class 2, 3 or 4 or patients with a history of congestive heart failure NYHA class 2, 3 or 4 in the past, unless a screening echocardiogram performed within 1 month prior to registration demonstrates a left ventricular ejection fraction that is ≥ 45%\n* History or risk of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n  * Patients with controlled Type 1 diabetes mellitus (HbA1c \\\u003C 8%) on a stable insulin regimen may be eligible.\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided all of the following conditions are met:\n\n    * Rash must cover less than 10% of body surface area (BSA).\n    * Disease is well controlled at baseline and only requiring low potency topical steroids.\n    * No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) within the previous 12 months.\n  * Any chronic skin condition that does not require systemic therapy.\n  * Patients without active disease in the last 5 years may be included but only after consultation with the study physician.\n  * Patients with celiac disease controlled by diet alone\n* Patients should not receive vaccines 30 days prior to registration. Patient is informed to not receive vaccines during treatment and through 30 days after the last dose of study treatment with the exception of seasonal influenza vaccines and vaccines intended to prevent SARS-CoV-2, pneumococcal infection and coronavirus disease 2019 (COVID-19). If a patient had received a live attenuated vaccine within 30 days of the first dose of trial treatment, eligibility should be discussed with the investigator\n* Patient has had major surgery within 4 weeks prior to registration\n* Patient has radiation therapy within 4 weeks prior to registration, excluding palliative and central nervous system (CNS) radiation\n* Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of iadademstat. In addition, patients with enteric stomata are also excluded\n* Patients with history of clinically significant bleeding, specifically any history of intracranial hemorrhage \u002F hemorrhagic cardiovascular accident (CVA), or patients with gastrointestinal bleeding within the 3 months prior to registration\n* Patients with known irreversible bleeding disorders or receiving antiplatelet therapy for other indications\n* Patients with uncontrolled disseminated intravascular coagulation\n* Patients who refuse or are unable to potentially receive blood products",{"count":60,"type":20},45,[62,23],"PHASE1","This phase I\u002FII trial tests the safety, side effects, and best dose of iadademstat when given together with atezolizumab or durvalumab, and studies the effect of the combination in treating patients with small cell lung cancer that has spread outside of the lung in which it began or to other parts of the body (extensive stage) who initially received standard of care chemotherapy and immunotherapy. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab or durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding iadademstat to either atezolizumab or durvalumab may be able to stabilize cancer for longer than atezolizumab or durvalumab alone in treating patients with extensive stage small cell lung cancer.",[27,65],"Stage IV Lung Cancer AJCC v8","2026-06-10",{"date":68,"type":32},"2026-06-11",{"date":70,"type":32},"2025-04-08",{"date":72,"type":20},"2029-07-25",{"name":38,"class":39},43,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100433073","phase-2-temozolomide-and-atezolizumab-for-subsequent-line-for-the-treatment-of-metastatic-or-recurrent-small-cell-lung-cancer-100433073","NCT04919382","Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer","A Randomized, Multi-Cohort Phase II Trial of Temozolomide and Atezolizumab for Subsequent Line Treatment for Small Cell Lung Cancer","Inclusion Criteria:\n\n* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\n\n  * NOTE: HIPAA authorization may be included in the informed consent or obtained separately\n* Age \\>= 18 years at the time of consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2 within 28 days prior to registration\n* Have histologically or cytologically-documented diagnosis of extensive stage (i.e. metastatic and\u002For recurrent) small cell lung cancer and have progressed or recurred after platinum-based chemotherapy with immunotherapy. Eligible patients will be defined as follows:\n\n  * \"Sensitive\" Disease: Patients who had one previous line of chemotherapy and relapsed after \\> 90 days of completion of treatment\n  * \"Resistant\" Disease: Patients with no response to first-line chemo-immunotherapy or progression \\\u003C 90 days after completing treatment\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to registration\n* Maximum of 3 prior lines of systemic therapy is allowed in the setting of metastatic disease. Patients who recur after treatment for limited state disease, and who receive first line metastatic treatment with chemo-immunotherapy would be considered eligible upon progression on chemo-IO in the metastatic setting\n* Absolute neutrophil count (ANC) \\>= 1.5 K\u002Fmm\\^3 (obtained within 28 days prior to registration)\n* Platelets \\>= 100,000 \u002F mcL (obtained within 28 days prior to registration)\n* Serum creatinine =\\\u003C 2.0 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine or creatinine clearance \\[CrCl\\]) \\>= 50 mL\u002Fmin as estimated by Cockcroft and Gault formula for subject with creatinine levels \\> 2 x institutional ULN (obtained within 28 days prior to registration)\n* Bilirubin =\\\u003C 1.5 X ULN OR direct bilirubin =\\\u003C ULN for subjects with total bilirubin levels \\> 1.5 ULN\n\n  * Patients with known Gilbert disease: serum bilirubin =\\\u003C 3 x ULN) (obtained within 28 days prior to registration)\n* Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) =\\\u003C 3 X ULN OR =\\\u003C 5 X ULN for subjects with liver metastases (obtained within 28 days prior to registration)\n* Albumin \\> 2.5 g\u002FdL (obtained within 28 days prior to registration)\n* International normalized ratio (INR) or prothrombin time (PT) =\\\u003C 1.5 x ULN for patients not receiving therapeutic anticoagulation (obtained within 28 days prior to registration)\n\n  * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN for patients not receiving therapeutic anticoagulation (obtained within 28 days prior to registration)\n\n  * For patients receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Females of childbearing potential must have a negative serum or urine pregnancy test within 14 days prior to registration\n* For women of childbearing potential: agreement to remain abstinent (refrain from vaginal intercourse) or use contraceptive methods and agreement to refrain from donating eggs, as defined below:\n\n  * Women must remain abstinent or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for 5 months after the final dose of atezolizumab or temozolomide. Women must refrain from donating eggs during this same period\n  * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices, and copper intrauterine devices\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, or post ovulation methods) and withdrawal are not adequate methods of contraception\n* For men able to father a child: agreement to remain abstinent (refrain from vaginal intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:\n\n  * With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 3 months after the final dose of temozolomide to avoid exposing the embryo. Men must refrain from donating sperm during this same period\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study\n* Availability of archival tissue, preferably a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. A recently obtained archival FFPE tumor tissue block from a primary or metastatic tumor resection or biopsy can be provided if it was obtained within 1 year of trial screening. Patients with tumor specimens older than 1 year, or who do not have biopsy specimen may still be eligible if deemed so by the sponsor-investigator.\n* Be willing to provide peripheral blood samples at specified time-points during the study\n* Life expectancy greater than 3 months as determined by the enrolling physician or protocol designee\n* Ability to swallow and retain oral medication\n\nExclusion Criteria:\n\n* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment\n* Has received prior temozolomide therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial\n* Symptomatic central nervous system (CNS) metastases or untreated or actively progressing CNS metastases. Subjects with asymptomatic CNS metastases (treated or untreated) will be eligible provided all of the following criteria are met.\n\n  1. Measurable disease, per RECIST v1.1, must be present outside the CNS.\n  2. The patient has no history of intracranial hemorrhage or spinal cord hemorrhage.\n  3. The patient has not undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment.\n  4. The patient has no ongoing requirement for corticosteroids as therapy for CNS disease at the time of study treatment.\n  5. If the patient is receiving anti-convulsant therapy, the dose is considered stable and appropriate by the treating physician.\n  6. Metastases are limited to the cerebellum or the supratentorial region (i.e., no metastases to the midbrain, pons, medulla, or spinal cord).\n\n     * NOTE: Subjects who are symptomatic and have not undergone prior brain imaging must undergo a head computed tomography (CT) scan or brain MRI within 28 days prior to registration to exclude brain metastases\n     * NOTE: A subject with previously treated brain metastasis may be considered if they have completed their treatment for brain metastasis at least 2 weeks prior to study registration and all of the above criteria are met.\n* Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy including:\n\n  * Tuberculosis (clinical evaluation that includes clinical history, physical examination, and radiographic findings, and TB testing in line with local practice)\n  * Hepatitis B (known positive HBV surface antigen \\[HBsAg\\] result)\n  * Hepatitis C, or\n  * Human immunodeficiency virus (positive HIV 1\u002F2 antibodies)\n  * NOTES: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. In patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA). Subjects with HIV\u002Facquired immunodeficiency syndrome (AIDS) with adequate antiviral therapy to control viral load (i.e undetectable) would be allowed if they are stable and have been on treatment for \\>= 4 weeks prior to first dose of study drug(s). Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy. Testing not required\n* Has had prior chemotherapy, immunotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =\\\u003C grade 1 or at baseline) from adverse events due to a previously administered agent\n\n  * Note: Subjects with =\\\u003C grade 2 neuropathy or alopecia due to chemotherapy are an exception to this criterion and may qualify for the study\n  * Note: If subject received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy\n  * Note: Subjects with irreversible toxicity that in the opinion of the treating physician is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, hormone deficiency requiring replacement therapy)\n* 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 disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n  * Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover =\\\u003C 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* 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 tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (more than once monthly). Patients with indwelling catheters (e.g., PleurX) are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\>12 mg\u002FdL or corrected serum calcium \\> ULN)\n* History of leptomeningeal disease",{"count":83,"type":20},56,[23],"This phase II trial studies the effects of temozolomide and atezolizumab as second or third line treatment for patients with small cell lung cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Chemotherapy drugs, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving temozolomide and atezolizumab as second or third line treatment may help prolong survival in patients with small cell lung cancer.",[27,87,88,65,89,90],"Metastatic Lung Small Cell Carcinoma","Recurrent Lung Small Cell Carcinoma","Stage IVA Lung Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8","2026-04-02",{"date":93,"type":32},"2026-04-08",{"date":95,"type":32},"2022-01-26",{"date":97,"type":20},"2028-12-30",{"name":99,"class":100},"Dwight Owen","OTHER",5,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":21,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":128},"100575195","phase-2-using-biomarker-tests-to-select-and-test-new-personalized-treatments-for-extensive-stage-small-cell-lung-cancer-prism-study-100575195","NCT06769126","Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study","PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)","Inclusion Criteria:\n\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have a history of limited stage small cell lung cancer\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must meet 1 of the following criteria prior to step 1:\n\n  * Treatment naïve and planning to receive frontline induction treatment with platinum plus etoposide in combination with durvalumab, OR,\n  * Have initiated frontline induction therapy and completed at least 1 (≥ 1) cycle and at most 3 (≤ 3) cycles of platinum and etoposide. At most 2 (≤ 2) of these cycles could have been given without durvalumab\n\n    * NOTE: Participants must not have received immunotherapy other than durvalumab (e.g., atezolizumab) prior to enrollment\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received any anti PD-1 or anti PD-L1 (including durvalumab \\[MEDI4736\\]) treatment for SCLC prior to starting frontline induction treatment for ES-SCLC\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received anti PD-1 or anti PD-L1 other than durvalumab (MEDI4736) as part of frontline induction treatment for ES-SCLC. Participants must have not received atezolizumab, pembrolizumab, or nivolumab as part of frontline induction treatment\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have received any investigational agent for the treatment of ES-SCLC\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for SCLC treatment while receiving treatment on this study\n\n  * NOTE: If participant has bone metastases, bisphosphonates are allowed\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have any unresolved toxicity National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must be ≥ 18 years old at the time of step 1 registration\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must be able to safely receive the frontline induction treatment with platinum plus etoposide in combination with durvalumab, per the current Food and Drug Administration (FDA)-approved package insert(s), institutional guidelines, and the treating investigator's discretion\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have Zubrod performance status of 0-2 within 28 days prior to step 1 registration\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator within 28 days prior to step 1 registration\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have had an allogenic organ transplantation\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: Participants must have adequate tumor tissue available from SCLC and agree to have these tissue specimens submitted. Participants must agree to have any leftover tissue (tissue that remains after subtype and biomarker testing) retained for the use of future correlative studies.\n\n  * NOTE: After a participant has been registered to step 1 registration, the tissue must be submitted to BostonGene. Sites will receive a notification from the Southwest Oncology Group (SWOG) Statistics and Data Management Center within 19 days after tissue submission. Patients must not be registered to step 2 prior to receiving notification of cohort assignment\n  * NOTE: A histologic review will be performed to confirm adequate cellularity for the testing. If inadequate cellularity, additional archival unstained slides from the same participant may be submitted if it does not exceed the window of starting maintenance therapy\n* STEP 1: SCREENING AND INDUCTION TREATMENT REGISTRATION: NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Site must have received notification from the SWOG Statistics and Data Management Center (SDMC) of the participant's SLFN11 testing results and have been determined to have subtype A, N, I, or P: confirmed by BostonGene and assigned to a cohort\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants may have measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) and must have their disease assessed by CT of chest\u002Fabdomen\u002Fpelvis (with contrast unless contraindicated) within 28 days prior to step 2 for measurable disease or within 42 days prior to step 2 for non-measurable disease. All known sites of disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1). Any lesions assessed using a non-diagnostic PET\u002FCT of chest\u002Fabdomen\u002Fpelvis will be considered non-measurable lesions\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to step 2 randomization. Participant must not have leptomeningeal disease, spinal cord compression, or symptomatic brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to step 2 randomization, AND (2) participant has no residual neurological dysfunction and has been off corticosteroids for at least 24 hours prior to step 2 randomization\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with untreated brain metastases must be asymptomatic and stable off steroids prior to step 2 randomization.\n\n  * NOTE: Exceptions to corticosteroid criterion are: (1) intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection), (2) systemic corticosteroids at physiologic doses not to exceed 10 mg\u002Fday of prednisone or its equivalent, or (3) steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication). Premedication with steroids for chemotherapy is acceptable\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have experienced disease progression in the opinion of treating investigator during induction treatment and prior to step 2\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have completed frontline induction therapy. Induction therapy must have included 4-6 cycles of platinum plus etoposide and 4 cycles of durvalumab (MEDI4736); at most 2 (≤ 2) cycles of platinum plus etoposide may have been given without durvalumab (MEDI4736). Durvalumab (MEDI4736) must have been given in combination with platinum plus etoposide\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants who received consolidation thoracic radiation therapy must have completed all radiation therapy at least 14 days prior to step 2\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: For participants not receiving consolidation thoracic radiation, step 2 registration must occur at least 3 weeks but not more than 6 weeks after the last dose of frontline induction therapy (platinum plus etoposide in combination with durvalumab \\[MEDI4736\\])\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: For participants receiving consolidation thoracic radiation after induction therapy, step 2 registration must occur at least 3 weeks but no more than 8 weeks after the last dose of frontline induction therapy (platinum plus etoposide in combination with durvalumab \\[MEDI4736\\])\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have received atezolizumab, pembrolizumab, or nivolumab as part of their frontline induction treatment. Participants must not have received prophylactic cranial irradiation (PCI)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have a complete medical history and physical within 28 days prior to step 2\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have body weight \\> 30 kg\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have Zubrod performance status of 0-2 within 28 days prior to step 2\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Hemoglobin \\> 9.0 g\u002FdL (within 28 days prior to step 2)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Absolute neutrophil count ≥ 1.5 x 10\\^3\u002FuL (within 28 days prior to step 2)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Platelets ≥ 100 x 10\\^3\u002FuL (within 28 days prior to step 2)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to step 2)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Aspartate aminotransferase (AST)\u002Falanine transaminase (ALT) ≤ 5 × institutional ULN (within 28 days prior to step 2)\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must have creatinine ≤ 1.5x the institutional upper limit of normal (IULN) OR measured OR calculated creatinine clearance ≥ 45 mL\u002Fmin using the following Cockcroft-Gault Formula For creatinine clearance formula see the tools on the Cancer Research and Biostatistics (CRA) Workbench https:\u002F\u002Ftxwb.crab.org\u002FTXWB\u002FTools.aspx\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to step 2 registration\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured or currently be receiving treatment for HVC. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have experienced the following during induction treatment: Any grade 3 or worse immune-mediated adverse event (irAE) (except asymptomatic nonbullous\u002Fnonexfoliative rash) or any unresolved grade 2 irAE, nor have experienced a toxicity that led to permanent discontinuation of prior durvalumab (MEDI4736). Toxicity of any grade that requires replacement therapy and has stabilized on therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must not have received a live or live attenuated vaccine within 30 days prior to step 2. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and COVID-19 vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed\n* STEP 2: COHORT REGISTRATION AND MAINTENANCE RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking",{"count":110,"type":20},900,[23],"This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.",[27,114,115,116,117],"Lung Small Cell Carcinoma, A Subtype","Lung Small Cell Carcinoma, I Subtype","Lung Small Cell Carcinoma, N Subtype","Lung Small Cell Carcinoma, P Subtype","2026-03-24",{"date":120,"type":32},"2026-03-30",{"date":122,"type":32},"2025-11-06",{"date":124,"type":20},"2029-12-31",{"name":126,"class":127},"SWOG Cancer Research Network","NETWORK",148,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":141,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100625511","phase-2-tarlatamab-for-the-treatment-of-extensive-stage-small-cell-lung-cancer-100625511","NCT07423585","Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer","A Front-Line Window-of-Opportunity Phase 2 Study of Tarlatamab (Bispecific T Cell Engager: DLL3-CD3) in Patients With Extensive-Stage Small-Cell Lung Cancer","Inclusion Criteria:\n\n* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\n\n  * NOTE: HIPAA authorization may be included in the informed consent or obtained separately\n* Age ≥ 18 years at the time of consent\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2\n* Have a histologically or cytologically documented new diagnosis of the extensive-stage (i.e., metastatic and\u002For recurrent) SCLC. Patients with multiple lung nodules and\u002For lymph node involvement that are too extensive or have tumor\u002Fnodal volume that is too large to be encompassed in a tolerable radiation plan are allowed\n\n  * Recurrent limited-stage SCLC disease after 6 months of completing standard-of-care systemic platinum-based chemotherapy and radiation can be considered after discussion with the sponsor\n* Measurable disease according to RECIST v 1.1\n* All patients must have brain MRI. Subjects with brain metastases are eligible provided they meet the following criteria:\n\n  * Patients with treated brain metastases are eligible if they completed definitive therapy at least 1 week prior to the first dose of tarlatamab, are asymptomatic (unless symptoms are deemed irreversible by the investigator), and on stable dose of steroids (=\\\u003C 10 mg prednisone equivalent) for at least 7 days prior to study treatment\n  * Patients with asymptomatic untreated brain metastases with no radiological evidence of vasogenic edema may be considered for inclusion after discussion with the sponsor\n* Absolute neutrophil count (ANC) ≥ 1500 cells\u002FuL\n* Platelets ≥ 100,000\u002FuL\n* Hemoglobin ≥ 9.0 g\u002FdL\n* Lymphocyte count ≥ 500\u002FuL\n* Estimated glomerular filtration rate (eGFR) based on MDRD (Modification of Diet in Renal Disease) calculation ≥ 30 mL\u002Fmin\u002F1.73 m\\^2\n* Total bilirubin \\\u003C 1.5 x upper limit of normal (ULN) (or \\\u003C 2 x ULN for subjects with liver metastases, or \\\u003C 3 x ULN for subjects with known Gilbert disease)\n* Aspartate aminotransferase (AST) \\\u003C 3 x ULN (or \\\u003C 5 x ULN for subjects with liver involvement)\n* Alanine aminotransferase (ALT) \\\u003C 3 x ULN (or \\\u003C 5 x ULN for subjects with liver involvement)\n* Alkaline phosphatase (ALP) \\\u003C 3 x ULN (or \\\u003C 5 x ULN for subjects with liver involvement)\n* Albumin ≥ 2.5 g\u002FdL\n* Patients with indwelling catheters (e.g., PleurX®) are allowed\n* Baseline oxygen saturation ≥ 90% on room air\n* Chronic obstructive pulmonary disease (COPD) patients on stable supplementary oxygen (O2) for at least 6 months may be considered for inclusion after discussion with the sponsor\n* Left ventricular ejection fraction (LVEF) ≥ 50%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no clinically significant electrocardiogram (ECG) findings\n* As determined by the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n* Availability of archival tissue, preferably a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block (or ideally at least 15 newly cut unstained slides). For eligibility, only confirmation of archival tissue is needed. Verification of tumor burden in the biopsy is encouraged. For optimal biomarker results, tumor content should be \\> 30% of total tissue area\n* Be willing to provide peripheral blood samples at specified time-points during the study\n\nExclusion Criteria:\n\n* Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment\n* Patients with a prior or concurrent malignancy whose natural history or treatment could potentially interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial\n* Symptomatic brain metastases and\u002For leptomeningeal disease\n* Clinically significant cardiovascular disease per the investigator. Examples include unstable arrhythmia, unstable angina, myocardial infarction, and\u002For symptomatic congestive heart failure (New York Heart Association class II) within 3 months of the first dose of tarlatamab\n* Current history of active and uncontrolled central nervous system (CNS) disease, such as stroke, transient ischemic attack, epilepsy, CNS vasculitis, or neurodegenerative disease\n\n  * Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 6 months and have no residual neurologic deficits as judged by the investigator are permitted to enroll\n  * Patients with a history of epilepsy who have had controlled symptoms and no seizures in the past 2 years are allowed\n* Subject with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of tarlatamab administration\n\n  * Subject has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the subject may be considered eligible for the study from an infection standpoint\n  * NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Subjects requiring oral antibiotics who have been afebrile for \\> 72 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as an exclusion criterion\n* Subjects with active hepatitis or HIV infection, testing is required\n\n  * Patients with a past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of hepatitis B virus surface antigen \\[HBsAg\\]) are eligible\n  * In patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n  * Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA\n  * Subjects with HIV\u002FAIDS with adequate antiviral therapy to control viral load (i.e., undetectable) and lymphocyte count would be allowed if they are stable and have been on treatment for ≥ 4 weeks prior to the first dose of study drug(s)\n  * Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy\n* Subject has known sensitivity and immediate hypersensitivity to any components of tarlatamab\n* Prior treatment for SCLC. Subjects with limited-stage SCLC (LS-SCLC) who progressed after 6 months from completing chemotherapy and radiation may be considered for inclusion after discussion with the sponsor\n\n  * Palliative radiotherapy is allowed to non-target lesions, and must have been completed at least 7 days prior to the first dose of tarlatamab\n  * Subjects with irreversible toxicity (defined as having been present and stable for \\> 21 days) that, in the opinion of the treating physician, is not reasonably expected to be exacerbated by the investigational product may be included (e.g., neuropathy, alopecia, hearing loss, hormone deficiency requiring replacement therapy)\n* Subjects who received major surgery within 30 days. Subjects must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy\n* Subjects with known active autoimmune disease or immune deficiency that has required systemic treatment or steroids (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study\n\n  * Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n  * Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Physiologic doses of steroids are permitted\n* Subjects with a known history of solid organ transplantation\n* Subjects with evidence of interstitial lung disease or active, non-infectious pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Subjects with history of radiation pneumonitis in the radiation field (fibrosis) are permitted\n* Subjects with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Live and live attenuated vaccination are prohibited within 28 days prior to the first dose of tarlatamab treatment and for the duration of study. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination should be avoided during screening at least 14 days prior to the first day of tarlatamab treatment\n* Subjects of both genders of child-bearing potential who are not willing to practice an acceptable method(s) of effective birth control while on study, and through 60 days (for female subjects) or through 60 days (for male subjects) after receiving last dose of tarlatamab\n\n  * Females who are pregnant or planning to become pregnant or breastfeeding or who plan to breastfeed while on study through 60 days after receiving the last dose of tarlatamab. Subjects who are willing to suspend breastfeeding prior to starting treatment with tarlatamab and do not intend to resume breastfeeding 60 days after receiving the last dose of tarlatamab can be enrolled.\n  * Males who are unwilling to abstain from sperm donation while on study and through 60 days after receiving the last dose of tarlatamab\n* Symptomatic pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n\n  * Patients with indwelling catheters (e.g., PleurX) are allowed\n* Subjects with uncontrolled respiratory symptoms or concern about impending respiratory failure due to tumor compression requiring urgent intervention\n* Subjects with a history or current evidence of clinically significant disease, condition, therapeutic intervention, or laboratory abnormality that would pose a risk to subject safety and might confound the study evaluation, procedures or completion or may interfere with the subject's participation for the full duration of the trial, in the opinion of the treating investigator",{"count":137,"type":20},39,[23],"This phase II trial tests the effect of tarlatamab in treating patients with small cell lung cancer (SCLC) that has spread from where it first started to other parts of the body (extensive-stage). SCLC is an aggressive cancer which has a low 5-year survival rate. Tarlatamab is a bispecific antibody that can bind to two different antigens at the same time. Tarlatamab binds to DLL3 which is a protein found on the surface of some types of tumor cells, including small-cell lung cancer, and to CD3 which is present on immune system T-cells (a type of white blood cell) and may interfere with the ability of tumor cells to grow and spread. This may increase the length of time to progression (growing, spreading, or getting worse) and help patients with extensive-stage SCLC live longer.",[27],[142,143,144,145],"tarlatamab","Small cell lung cancer","extensive stage small cell lung cancer","window of opportunity","2026-02-13",{"date":148,"type":32},"2026-02-20",{"date":150,"type":20},"2026-04-01",{"date":152,"type":20},"2027-12-31",{"name":154,"class":100},"Asrar Alahmadi",1,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":155},"100415971","phase-2-lamivudine-in-combination-with-chemoimmunotherapy-for-the-treatment-of-extensive-stage-small-cell-lung-cancer-100415971","NCT04696575","Lamivudine in Combination With Chemoimmunotherapy for the Treatment of Extensive Stage Small Cell Lung Cancer","A Phase II Trial of Lamivudine in Combination With Chemoimmunotherapy in Patients With Extensive Stage SCLC","Inclusion Criteria:\n\n* Age \\>= 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 1 at the time of study treatment initiation\n* Histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC)\n* Patient should have extensive stage disease, defined as, malignant pleural effusion, pulmonary metastases in a different lobe in the ipsilateral lung or contralateral lung, and\u002For the presence of extra-thoracic metastatic disease\n* Must have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 prior to starting platinum-based systemic chemotherapy\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Hemoglobin \\>= 9 g\u002FdL\n* Serum creatinine =\\\u003C 1.5 x institution upper limit of normal (ULN) and calculated creatinine clearance of at least 15 ml\u002Fmin\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 3 x upper limit of normal (ULN) (ALT and AST =\\\u003C 5 x ULN is acceptable if liver metastases are present)\n* Total serum bilirubin =\\\u003C 1.5 x ULN. For patients with well documented Gilbert's syndrome, total bilirubin =\\\u003C 3 x ULN with direct bilirubin within normal range\n* Newly diagnosed SCLC patients may receive no more than 1 cycle of standard chemotherapy or chemoimmunotherapy for their current diagnosis prior to study treatment\n* Patients who have progressed on prior treatment for SCLC will be eligible if both of the following conditions are met:\n\n  * Received no more than one-line of treatment with platinum-based chemotherapy for SCLC, and\n  * Last platinum-based treatment administered \\>= 12 months prior to diagnosis of recurrence\u002Frelapse. Patients should not have experienced disease progression while receiving prior platinum-based treatment for SCLC\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Receipt of anticancer chemotherapy\u002Fchemoimmunotherapy within 4 weeks prior to the first administration of study drug other than what is allowed in the inclusion criteria\n* Symptomatic brain metastasis\n\n  * Patients with treated brain metastases are eligible provided they have recovered from effects of radiation and neurological symptoms are improved or controlled for at least two weeks prior to enrollment\n  * Patients with asymptomatic brain metastases who are being treated with systemic chemotherapy alone are also eligible if no more than 6 lesions each less than 1 cm in size is present at the time of initiating protocol treatment\n* Leptomeningeal involvement regardless of treatment status\n* Participation in another interventional study within the last 28 days of study enrollment\n* Had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered major surgery) resulting from a prior surgery\n* Positive for immunosuppressive disease, acquired immunodeficiency syndrome (AIDS) or other immune depressing diseases. For human immunodeficiency virus (HIV), HVC and HBC-mandatory testing is required prior to enrollment\n\n  * Note: Patients with past or resolved hepatitis B virus (HBV) infection (defined as the presence of hepatitis B surface antibody \\[HBsAb\\] and absence of hepatitis B surface antigen \\[HBsAg\\]) are eligible (HBV deoxyribonucleic acid \\[DNA\\] should be obtained in patients if only anti-hepatitis B core \\[HBc\\] antibody was present prior to randomization). Patients with active\u002Funtreated hepatitis C virus (HCV) will be excluded from the study; patients who test positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\n* Active, clinically serious infections or other serious uncontrolled medical conditions, including chronic viral hepatitis (testing for hepatitis B, C required)\n* Patient has known hypersensitivity to the components of the study drugs or any analogs\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:\n\n  * Myocardial infarction or arterial or venous thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) class III or IV disease\n  * History of documented congestive heart failure (New York Heart Association functional classification III or IV) within 6 months prior to baseline\n  * Poorly controlled arrhythmias\n* Contraindications to atezolizumab: Patients with active autoimmune disorder or prior history of autoimmune disorder requiring immunosuppressive agents within preceding two years will not be allowed to receive atezolizumab but will be able to receive the other drugs included in the treatment regimen, if eligible",{"count":164,"type":20},28,[23],"This phase II trial studies the effect of lamivudine in combination with standard of care chemoimmunotherapy in treating patients with extensive stage small cell lung cancer. Even though small cell lung cancer is initially highly responsive to first-line chemotherapy treatment, treatment resistance inevitably emerges; treatment resistance is when tumor cells stop responding to a drug treatment that they had previously responded to. Lamivudine is an oral antiviral a drug that may be able to reduce the ability of tumors to develop drug resistance. Chemotherapy drugs, such as carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lamivudine together with the usual standard of care chemoimmunotherapy may help prevent the growth and spread of the tumor cells to other parts of the body.",[27],"2025-12-09",{"date":170,"type":32},"2025-12-15",{"date":172,"type":32},"2021-07-02",{"date":174,"type":20},"2027-07-01",{"name":176,"class":100},"Roswell Park Cancer Institute",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":21,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"100458024","phase-1-palliative-radiotherapy-with-lurbinectedin-in-patients-with-extensive-stage-small-cell-lung-cancer-100458024","NCT05244239","Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer","A Phase I Study of Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3\n* Patients with pathologically confirmed ES-SCLC who are receiving lurbinectedin or are candidates for lurbinectedin therapy after progression on first-line systemic therapy (either chemotherapy \\[platinum etoposide\\] or chemoimmunotherapy) at the discretion of the treating medical oncologist.\n* Metastatic bone or visceral\u002Flung metastatic disease as assessed computed tomography (CT), magnetic resonance imaging (MRI), bone scan or positron emission tomography (PET)\u002FCT within 90 days prior to RT on this study.\n* Patients with treated brain metastases are eligible but must require \\\u003C 10 mg of dexamethasone daily or its glucocorticoid equivalent. Brain metastases will not be treated in the context of this protocol.\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fcells\u002Fmm\\^3\n* Platelets \\>= 100,000\u002Fcells\u002Fmm\\^3\n* Hemoglobin \\> 7.0 g\u002FdL\n* Total Bilirubin ≤ 1.5 ULN\n* Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) =\\\u003C 3.0 x ULN (=\\\u003C 5.0x ULN for liver involvement)\n* Alkaline phosphatase =\\\u003C 2.5x ULN (=\\\u003C 5.0x with documented liver or bone metastases)\n* Based on its mechanism of action, lurbinectedin could cause harm when administered to a pregnant woman. Taken together with the known teratogenicity of RT, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting protocol therapy. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months.\n* FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and 6 months after the final dose of lurbinectedin. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of lurbinectedin administration. FCBP who are currently breastfeeding must discontinue during and up to 2 weeks after the final dose of lurbinectedin.\n* Completion of all previous cancer-directed therapies (excluding lurbinectedin) for the treatment of cancer \\>= 3 weeks before the start of study therapy.\n* Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.\n* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnancy or breastfeeding within 2 weeks\n* Patients may not enroll in both safety cohorts\n* Patients who have received prior RT will be permitted to enroll. However, the metastases treated on this study must be \\> 2 cm from the following previously irradiated structures:\n\n  * Spinal cord previously irradiated to \\> 40 Gy (delivered in =\\\u003C 3Gy\u002Ffraction)\n  * Brachial plexus previously irradiated to \\> 50Gy (delivered in =\\\u003C 3Gy\u002Ffraction)\n  * Small intestine, large intestine, or stomach previously irradiated to \\> 45Gy (delivered in =\\\u003C 3Gy\u002Ffraction)\n  * Brainstem previously irradiated to \\> 50Gy (delivered in =\\\u003C 3Gy\u002Ffraction)\n  * Lungs previously irradiated with prior V20Gy \\> 35 percent (delivered in =\\\u003C 3Gy\u002Ffraction)",{"count":185,"type":20},22,[62],"This phase I trial aims to determine if it is safe to use palliative radiotherapy and lurbinectedin at the same time to treat small cell lung cancer that has spread outside of the chest and that has grown after being treated with chemotherapy (extensive stage). Lurbinectedin kills tumor cells by blocks a process called transcription that small cell lung cancer relies on to survive. It also damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Palliative radiotherapy is a routine medical treatment for patients who have lung cancer that has spread to other parts of the body (metastatic), and is used to relieve symptoms caused by cancer or to patients from developing symptoms. This trial may help doctors understand if treating patients with lurbinectedin and palliative radiotherapy at the same time would make them both work better than either one alone or if they could cause more side effects for patients when given together.",[27,65],"2025-10-29",{"date":191,"type":32},"2025-10-31",{"date":193,"type":32},"2022-07-27",{"date":195,"type":20},"2027-07-28",{"name":197,"class":100},"Emory University",3,{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":210,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100567741","phase-3-adebrelimab-combined-with-chemotherapy-and-thoracic-radiotherapy-for-first-line-treatment-of-es-sclc-100567741","NCT06672133","Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC","Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC: a Randomized Controlled Phase III Clinical Study","RALLY","Inclusion Criteria:\n\n1. Aged 18-75 years, male or female;\n2. Histologically or cytologically confirmed extensive stage small cell lung cancer (according to the Veterans Lung Administration Lung Study Group, VALG stage);\n3. ECOG performance status score 0 \\~ 1;\n4. No prior line of systemic therapy for ES-SCLC;\n5. Liver metastases ≤ 3 at diagnosis;\n6. Patients without previous brain metastases or treated asymptomatic CNS metastases,\n7. Expected survival ≥ 12 weeks;\n8. At least one measurable target lesion (according to RECISTv1.1 criteria) on imaging assessment (CT or MRI) within 4 weeks prior to enrollment;\n9. The function of vital organs meets the requirements;\n10. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must agree to use effective contraception during the trial and 2 months after the last dose of adalimumab or 6 months after the chemotherapy agent, whichever is longer;\n11. Patients voluntarily join this study, sign informed consent, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Histologically or cytologically determined as a mixed pathological type with components such as non-small cell lung cancer;\n2. Active or untreated CNS metastases detected by computed tomography (CT) or magnetic resonance imaging (MRI) during the screening period and previous imaging assessments;\n3. Spinal cord compression that is not relieved by surgery and\u002For radiotherapy;\n4. Clinically symptomatic third space effusion requiring repeated drainage within 2 weeks, such as pericardial effusion, pleural effusion, and abdominal effusion that are still uncontrollable by pumping or other treatments;\n5. Complicated with other malignant tumors ≤ 5 years before the first dose, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed);\n6. Patients with active, known, or suspected autoimmune disease. Patients with type 1 diabetes treated with stable doses of insulin, hypothyroidism requiring hormone replacement therapy only, and skin diseases (e.g., eczema, vitiligo, or psoriasis) not requiring systemic therapy and not exacerbated within the year before the screening period were excluded;\n7. Patients diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy not directly related to tumor therapy within 7 days before the first dose of study drug; physiological doses of glucocorticoids (prednisone ≤ 10 mg\u002Fday or equivalent) are allowed;\n8. HBsAg positive and HBV DNA copy number greater than the upper limit of normal (1000 copies\u002Fml or 500 IU\u002Fml), or HCV positive (HCV RNA or HCV Ab detection suggests acute and chronic infection); known HIV positive history or known acquired immunodeficiency syndrome (AIDS);\n9. A history of idiopathic pulmonary fibrosis, interstitial pneumonia, tissue pneumonia (such as occlusive vasculitis), drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or clinically symptomatic active pneumonia; or other severe lung disease that seriously affects lung function;\n10. Patients with active pulmonary tuberculosis (TB) or history of active pulmonary tuberculosis infection ≤ 48 weeks before screening, regardless of treatment;\n11. Presence of severe infection at randomization, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.;\n12. Major surgery within 28 days prior to randomization, or planned major surgery during the study period;\n13. Use of live attenuated vaccines within 28 days prior to randomization, or anticipated need for live attenuated vaccines during the study;\n14. Cardiac function and disease which is considered clinically significant by the investigator;\n15. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation;\n16. Known hypersensitivity to the study drug or excipients, known serious allergic reactions to any monoclonal antibody; history of allergy to carboplatin\u002Fcisplatin or etoposide;\n17. Received any other investigational drug or participated in another interventional clinical study within 4 weeks before signing the ICF;\n18. Known mental illness, alcoholism, inability to quit smoking, drug abuse or drug abuse;\n19. Pregnant or lactating women; as judged by the investigator, the patient has other factors that may cause forced halfway termination of this study, such as non-compliance with the protocol, other serious diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, accompanied by family or social factors, which may affect the safety of patients, or the collection of data and samples.","75 Years",{"count":209,"type":20},524,[24],"This phase III trial compares the effect of adding radiation therapy to the usual maintenance therapy with adebrelimab versus adebrelimab alone in patients who have already received debrelimab plus chemotherapy for the treatment of extensive stage small cell lung cancer.",[27],[214,215,216],"adebrelimab","radiotherapy","ES-SCLC","NOT_YET_RECRUITING","2024-11-02",{"date":220,"type":32},"2024-11-05",{"date":222,"type":20},"2024-12",{"date":224,"type":20},"2029-12",{"name":226,"class":100},"Jinming Yu",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":21,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":155},"100524579","phase-1-phase-iii-trial-in-es-sclc-to-enhance-response-to-atezolizumab-plus-chemotherapy-with-total-body-irradiation-100524579","NCT06110572","Phase I\u002FII Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation","(TESSERACT): Phase I\u002FII Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation (TBI)","TESSERACT","Inclusion Criteria:\n\n* Age ≥ 18 years at time of informed consent\n* Histologically documented or cytologically confirmed diagnosis of extensive stage small-celllung cancer with evaluable disease per RECIST v1.1 criteria. Patients may be considered extensive-stage based on M1 disease per AJCC 8th edition, OR may be clinically staged as extensive-stage disease based on anatomical extent that would preclude the use of standard radiotherapy fields as assessed by the treating radiation oncologist.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n* Platelet count ≥ 100 x 10\\^9\u002FL\n* Lymphocyte count ≥ 0.5 x 10\\^9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN, alanine aminotransferase (ALT) ≤ 2.5 x ULN and alkaline phosphatase ≤ 2.5 x ULN\n* Creatinine ≤ 1.5 x ULN or calculated creatinine clearance (CrCl) ≥ 50 mL\u002Fmin if creatinine (Cr) \\> 1.5 x ULN. GFR can also be utilized. If no local calculation guidance on CrCl, should be calculated according to Cockcroft-Gault Method\n* International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulation therapy. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen.\n* Negative HIV test at screening, with the following exception: patients with positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200, and have an undetectable viral load\n* Negative Hepatitis B surface antigen at screening\n* Presence of brain metastases allowed (should undergo management with surgery and\u002For radiation therapy if symptomatic prior to TESSERACT radiation regimen; upfront cranial irradiation not mandatory on protocol if asymptomatic)\n* Contraceptive use should be initiated or continued per guidance in labeling for approved chemotherapies\n* Female patients must be non-pregnant and not breastfeeding\n* Women of childbearing potential (WOCBP) must remain abstinent or use contraceptive methods with a failure rate of \\\u003C1% per year during the treatment period and for 5 months after the final dose of atezolizumab. A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a post-menopausal state (12 months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.\n\n  * Examples of contraceptive methods with a failure rate of \\\u003C1% per year include, bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptomthermal or postovulation methods) and withdrawal are not adequate methods of contraception.\n  * With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 5 months after the final dose of atezolizumab. Men must refrain from donating sperm during this same period.\n  * With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 5 months after the final dose of atezolizumab to avoid exposing the embryo.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal.\n* Eligible for immunotherapy-based systemic regimens per judgment of patient's study physician\n* Able to submit written informed consent\n\nExclusion Criteria:\n\n* Major surgery (requiring general anesthesia or at discretion of study physician) within 4 weeks prior to study enrollment that would prevent treatment with TESSERACT regimen\n* Known clinically significant (per study physician) acute or chronic infections including HIV (per inclusion criteria above), hepatitis B virus (HBV), hepatitis C virus (HCV) or active tuberculosis (testing not required for tuberculosis \\[TB\\]). Patients with HCV must be on stable dose of antiviral therapy on study entry. Current treatment with antivirals for HBV is not allowed on study\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Uncontrolled hypertension (average systolic blood pressure greater than or equal to 140 or average diastolic blood pressure greater than or equal to 90 despite optimal medical therapy). Patients with hypertension (systolic blood pressure \\[SBP\\] ≥ 140 and\u002For diastolic blood pressure \\[DBP\\] ≥ 90) may enroll provided that an effective anti- hypertensive regimen is initiated.\n* History of prior malignancy within 3 years of enrollment, except for adequately treated basal or squamous cell carcinoma of the skin, adequately treated carcinoma in situ (e.g. cervix or non- invasive bladder cancer) or other malignancy with minimal risk of metastasis or death (survival \\> 90% at 5 years)\n* Receipt of prior courses of cytotoxic chemotherapy or anti-neoplastic biologic\u002Fimmunotherapy for current malignancy (other than the current course of therapy). Patients may have undergone 1 cycle of 1st line of systemic therapy for SCLC prior to enrollment as long as the systemic therapy is congruent with what is included in the protocol and part of the current course of therapy.\n* Prior radiotherapy that would preclude delivery of protocol- based radiotherapy to normal organ tolerance per patient's study physician\n* Receipt of live attenuated vaccine within 28 days of cycle 1, day 1 (C1D1), and for 5 months after the last dose of atezolizumab.\n* Use of prohibited concomitant drug\n* Concurrent enrollment in another clinical trial (unless observational or within follow-up period)\n* Known, pathologically confirmed malignant pleural effusions (diagnostic evaluation of pleural effusions are recommended but not required for study entry, especially if sampling is deemed technically challenging at discretion of treating physician)\n* Uncontrolled pleural or pericardial effusion or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed\n* History of leptomeningeal disease\n* Uncontrolled tumor-related pain: Patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy can undergo treatment with palliative radiotherapy prior to enrollment at discretion of treating physicians. Patients should be recovered from effects of radiation and there is no required minimum recovery period. 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) can be considered for loco-regional therapy at discretion of treating physician prior to enrollment.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* 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 disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid- replacement hormone are eligible for the study\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all the following conditions are met:\n\n    * Rash must cover \\\u003C 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical steroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* 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 CT scan\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell or solid organ transplantation\n* Any other disease, metabolic dysfunction, physical examination finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti- CTLA-4, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents including, but not limited to, interferon and interleukin 2 (IL-2) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-alpha agents, within 2 weeks prior to initiation of study treatment with following exceptions:\n\n  * Patients 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 for the study after Principal Investigator confirmation has been confirmed)\n  * Patients who are receiving mineral corticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal sufficiency are eligible for the study.\n  * Systemic steroids required during therapy for adverse event (AE) management are allowed.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months of the last dose of Atezolizumab. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.",{"count":236,"type":20},18,[62,23],"This phase I\u002FII trial studies the side effects, safety, and effectiveness of low dose radiation to the entire body (total body irradiation \\[TBI\\]) and higher dose radiation to known areas of cancer (hypofractionated radiation therapy \\[H-RT\\]) combined with atezolizumab and chemotherapy (carboplatin \\& etoposide) in treating patients with small cell lung cancer that has spread to disease sites outside of the lung (extensive stage). Extensive stage disease has historically been treated with chemotherapy alone with consideration of chest (thoracic) radiation therapy for those with response to chemotherapy, as well as consideration of preventative radiation therapy to the head (prophylactic cranial irradiation). Emerging evidence supports the synergistic interactions between immunotherapy and radiation therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Combining TBI and H-RT with atezolizumab and chemotherapy may improve response to treatment.",[27,240],"Stage IV Lung Cancer","2024-06-18",{"date":243,"type":32},"2024-06-20",{"date":245,"type":32},"2024-04-24",{"date":247,"type":20},"2028-06-30",{"name":249,"class":100},"Vanderbilt-Ingram Cancer Center"]