[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stage-iv-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stage-iv-lung-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,84],{"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":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100557432","prospective-non-interventional-study-comparing-osimertinib---chemotherapy-for-egfr-mutated-nsclc-patients-100557432",false,"NCT06538038","Prospective Non-Interventional Study Comparing Osimertinib +\u002F- Chemotherapy for EGFR-Mutated NSCLC Patients","Prospective Non-Interventional Study Comparing Standard of Care Osimertinib +\u002F- Chemotherapy for EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Patients","Inclusion Criteria:\n\n* Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).\n* Patient must have advanced disease, defined as IIIB (not amenable to definitive multi-modality therapy), IIIC, or IV (includes local or distant recurrent disease after a prior diagnosis of Stage I-III disease). All staging is via the American Joint Committee on Cancer (AJCC)\u002FInternational Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria.\n* Patient tumor must have somatic activating sensitizing mutation in EGFR (e.g., but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Plasma, cytology, or tumor tissue can be utilized for standard of care mutation testing.\n* Prior chemotherapy and\u002For immunotherapy administered as primary treatment for NSCLC before EGFR mutation was identified is allowed ≤ 45 days of study registration to allow for return of sequencing information.\n* Prior treatment with osimertinib administered as primary treatment for NSCLC is allowed ≤ 30 days of study registration (prior treatment with any other EGFR TKI agent is not allowed).\n* Patient must not be participating in EA5182 or any other cancer treatment trial. Osimertinib or osimertinib + chemotherapy\u002Fimmunotherapy given as first-line treatment for this disease cannot be given as part of a clinical trial.\n* Patients that have received prior radiation therapy in any setting for this disease are eligible.\n* Adults age ≥ 18 years.","ALL","18 Years",{"count":19,"type":20},538,"ESTIMATED","3 Years","OBSERVATIONAL","The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens.",[25,26,27,28],"Non Small Cell Lung Cancer","Epidermal Growth Factor Receptor Gene Mutation","Stage III Lung Cancer","Stage IV Lung Cancer",[30,31,32,33,34],"Osimertinib","Cisplatin","Carboplatin","Pemetrexed","EGFR Mutated","RECRUITING","2026-03-26",{"date":38,"type":39},"2026-03-27","ACTUAL",{"date":41,"type":39},"2024-09-17",{"date":43,"type":20},"2029-08",{"name":45,"class":46},"PrECOG, LLC.","OTHER",146,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":83},"100585017","phase-1-cisplatin-cis-administered-as-dry-powder-for-inhalation-dpi-in-patients-with-stage-iv-non-small-cell-lung-cancer-100585017","NCT06896890","Cisplatin (CIS) Administered As Dry Powder for Inhalation (DPI) in Patients with Stage IV Non-Small Cell Lung Cancer","A Phase I\u002FII First-in-human Trial Investigating Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of a Dry Powder Cisplatin Formulation for Inhalation to Treat Stage IV Non-small Cell Lung Cancer Patients","Inclusion Criteria:\n\n* The patient must be ≥18 years of age at the time of signing the informed concent form (ICF).\n* The patient must have a pathologically or cytologically confirmed Stage IV NSCLC that could be treated with pembrolizumab alone or combined with carboplatin\u002Fpemetrexed or paclitaxel.\n* The patient must have measurable disease according to RECIST 1.1.\n* The patient must be treatment naïve for stage IV NSCLC at the time of study enrolment. Patients having received, at least 6 months before D1, platinum derivatives adjuvant after (i) surgery or (ii) concomitant chemotherapy-radiotherapy for unresectable locally advanced NSCLC are eligible.\n* The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* The patient must have adequate organ function values as follows:\n\n  1. Haematology:\n\n     1. Platelet count \\>100,000 cells\u002Fmm3.\n     2. Absolute neutrophil count \\>1,500 cells\u002Fmm3.\n     3. Haemoglobin \\>9 g\u002FdL.\n  2. Serum creatinine less or equal to upper limit of normal (ULN) or creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m2 on the basis of Cockcroft-Gault glomerular filtration rate estimation.\n  3. Coagulation:\n\n     1. International normalised ratio (INR) ≤1.5; for patients treated with coumarins INR ≤3 is acceptable.\n     2. Prothrombin time (PTtest) and activated partial thromboplastin time (aPTT) \\\u003C1.6 x ULN unless therapeutically warranted.\n  4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C3 x ULN. In case of hepatic metastasis, AST and ALT \\\u003C5 x ULN.\n  5. Bilirubin ≤1.5 x ULN, except for patients with known familial hyperbilirubinemia (such as Gilbert syndrome); for patients with documented Gilbert's syndrome (Gilbert-Meulengracht syndrome) total bilirubin of ≤3 x ULN is acceptable.\n* The patient must have a resting oxygen saturation of at least 90%, a FEV1 ≥50% of predicted values as determined by spirometry and a DLCO of at least 50%.\n* The patient is able to manipulate adequately the refillable single-dose (RS01) capsule-based device.\n* Women of childbearing potential should have a negative serum pregnancy test, and be not pregnant or breastfeeding at screening.\n* Male patients that are able to father children and female patients of childbearing potential must agree to use highly effective methods of contraception throughout the study and for at least 6 months after the last dose of CIS-DPI.\n* The patient has given written informed consent prior to any study-specific procedures.\n* The patient has the willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.\n\nExclusion Criteria:\n\n* Patients with contraindication to or unwillingness to undergo contrast-enhanced computed tomography (CT) scans and chest X-rays according to the protocol requirements.\n* Patients who are participating in an investigational drug or device study within 4 weeks prior to the planned day for the first study treatment administration (D1).\n* Patients who have been treated by any anti-neoplastic agent within 6 months prior to the planned day for the first study treatment administration (D1).\n* Patients who have received prior therapy with an immune checkpoint inhibitor.\n* Patients who have received prior radiotherapy (head, neck, thorax, or abdomen) within 4 weeks prior to the planned day for the first study treatment administration (D1) except palliative radiotherapy (2 weeks). Patients must have recovered from all radiation-related toxicities, not require corticosteroids (see criterion 2425) and not have had radiation pneumonitis \\>grade 2.\n* Patients with concurrent thoracic irradiation for the treatment of lung cancer.\n* Patients who underwent major surgery within 4 weeks before the planned day for the first study treatment administration (D1).\n* Patients with EGFR activating mutation or ALK translocation, or any other activable molecular alterations that in the opinion of the investigator could be more effectively treated with targeted therapies (Note: This exclusion criterion must be checked before the first SoC administration).\n* Non-smoking patients without results of Epidermal growth factor receptor (EGFR) mutation and anaplastic large-cell lymphoma kinase (ALK) translocation before the planned day for the first study treatment administration (D1).\n* Patients with known pre-existing hearing impairment due to VIII nerve alteration.\n* Patients presenting a history of previous severe intolerance to or sensitivity to cisplatin, vitamin E or lactose.\n* Patients with mouth problems (e.g. cleft palate) or other abnormalities that would prevent tight fit of the mouth seal.\n* Patients with uncontrolled symptomatic pleural effusion or uncontrolled pneumothorax.\n* Patients having undergone pneumonectomy or bilobectomy (except if bilobectomy includes the right middle lobe).\n* Patients with a known history of severe cough\u002Fbronchospasm upon inhalation of dry powder inhalation products.\n* Patients with a known history or current evidence of any chronic upper or lower respiratory conditions (other than asthma and allergic or non-allergic rhinitis). History of mild acute upper or lower respiratory conditions are allowed, provided that the condition has been resolved at least 3 months before the planned day for the first study treatment administration (D1) and provided that, in the investigator's judgement, this occurrence poses no additional risk for this subject.\n* Patients with a known history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, acute exacerbation of chronic obstructive pulmonary disease (COPD) in the last 3 months before D1 (even if managed in an outpatient setting), known history of interstitial lung disease (ILD), or (non-infectious) pneumonitis that require steroids or that have current pneumonitis.\n* Patients with uncontrolled asthma, as defined in the Global Initiative for Asthma (GINA) 2020 guidelines. Patients with (i) a history of asthma or (ii) controlled active asthma treated with long-acting beta-2 mimetics with or without inhaled corticosteroids and having less than one asthma crisis per month, are eligible.\n* Patients with uncontrolled or severe active infection.\n* Known positivity for human immunodeficiency virus (HIV) or history of HIV (HIV testing is not mandatory):\n* Active hepatitis B virus (HBV; chronic or acute) defined as having a positive hepatitis B surface antigen (HBsAg) test at screening. Patients with past or resolved HBV infection (defined as having a negative HBsAg test and a positive hepatitis B core antigen antibody test) are eligible.\n* Active hepatitis C virus (HCV) infection defined as having a positive HCV antibody test followed by a positive HCV ribonucleic acid (RNA) test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test. Patients who are positive for HCV antibodies are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n* Positivity for Coronavirus Disease 2019 (COVID-19) by PCR testing. PCR result must not be older than 72 hours prior to the planned day for the first study drug administration (D1). Completed vaccination or prior COVID-19 infection does not exempt patients from PCR testing.\n* Live virus vaccine within 30 days prior to the planned day for the first study treatment administration (D1) (Note: inactivated seasonal flu vaccine is acceptable).\n* Patients using oral corticosteroids within 4 weeks1 week prior to the planned day for the first study treatment administration (D1) above daily dose of 10 mg or any single dose of 16 mg. Patients receiving inhaled or topical corticosteroids are eligible.\n* Patients who are presenting persistent toxicities greater than or equal to Common Terminology Criteria for Adverse Events (CTCAE version 5.0) grade 2 caused by previous cancer therapy (except for clinically non-significant toxicities, such as alopecia).\n* Patients having a current active malignancy with the exception of adequately-treated basal or squamous cell carcinoma of the skin, preinvasive carcinoma of the cervix, in situ carcinoma of the breast or low-grade prostate cancer with no plan for treatment intervention. Patients with previous history of malignancy provided that patient has been free of disease for at least 3 years may be included.\n* Patients with a known history of arterial thromboembolic event (ATE) or venous thromboembolic event (VTE) within 3 months prior to the planned day for the first study treatment administration (D1).\n* Patients with a known history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, uncontrolled ventricular arrhythmia (including but not limited to ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest.\n* Patients with significant or uncontrolled congestive heart failure (CHF) with Left Ventricular Ejection Fraction Assessment (LVEF) of less than 40%, significant or uncontrolled myocardial infarction or significant ventricular arrhythmias within the last 6 months prior to the planned day for the first study treatment administration (D1).\n* Patients who have uncontrolled hypertension defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg despite standard medical management with ≥2 anti-hypertensive drugs.\n* Patients with a known history of organ transplant or current active immunosuppressive therapy (such as cyclosporine, tacrolimus).\n* Patients with known history or presence of clinically relevant central nervous system (CNS) pathology, any autoimmune disease or significant coagulation disorder.\n* Patients with carcinomatous meningitis or CNS metastases, except where such metastases are stable and already irradiated.\n* Patients with peripheral neuropathy \\>grade 1.\n* Patients with any significant medical condition that in the opinion of the investigator makes participation in the trial against the patients' best interests.\n* Patients who are unwilling or unable to comply with the study protocol for any other reason.",{"count":56,"type":20},32,"INTERVENTIONAL",[59,60],"PHASE1","PHASE2","The combination of chemotherapy and immunotherapy shows promising results in terms of overall survival (OS) and progression-free survival (PFS) for the treatment of first-line stage IV non-small cell lung cancer (NSCLC) patients, leading to such combinations becoming a real backbone of the Standard of Care (SoC) for NSCLC patients.\n\nHowever, conventional chemotherapy's severe systemic toxicities represent a limiting factor in terms of administered dose and frequency. Administration of cisplatin by inhalation (pulmonary route) is a promising additional approach that may overcome the limitations of conventional chemotherapy.\n\nUse of a dry powder inhaler enables a high therapeutic response by delivering high local concentrations of a well-established active substance without the usual undesired reactions that limit the use of high doses when administered through the conventional systemic route.\n\nThis study may provide insights into whether this add-on treatment might be a safe and potentially efficacious option for NSCLC patients.",[63,28],"NSCLC (advanced Non-small Cell Lung Cancer)",[65,66,67,68,69,70,71,72],"non-small cell lung cancer","NSCLC","cisplatin","inhaled","pulmonary administration route","CIS-DPI","Dry Powder for Inhalation","Stage IV Non-Small Cell Lung Cancer","2025-03-25",{"date":75,"type":39},"2025-03-26",{"date":77,"type":39},"2023-06-23",{"date":79,"type":20},"2026-10-01",{"name":81,"class":82},"Inhatarget Therapeutics","INDUSTRY",15,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":57,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"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":93,"type":20},18,[59,60],"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.",[97,28],"Extensive Stage Lung Small Cell Carcinoma","2024-06-18",{"date":100,"type":39},"2024-06-20",{"date":102,"type":39},"2024-04-24",{"date":104,"type":20},"2028-06-30",{"name":106,"class":46},"Vanderbilt-Ingram Cancer Center",1]