[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ETOP IBCSG Partners Foundation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":142},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,69,93,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100608553","phase-2-a-trial-of-tarlatamab-in-patients-with-pretreated-extensive-stage-small-cell-lung-cancer-es-sclc-and-ecog-ps-2-100608553",false,"NCT07203053","A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2","A Multicentre Phase II Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2","START-lung","Inclusion Criteria:\n\n* Histologically or cytologically confirmed ES-SCLC.\n* Previous treatment with only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition for SCLC.\n\nPatients treated with a platinum-etoposide doublet chemotherapy for prior limited stage (LS)-SCLC may be eligible for the study if the disease has progressed on treatment or within 6 months from chemotherapy completion (i.e. during durvalumab consolidation): the platinum-etoposide line of therapy will count as one prior line of therapy.\n\n* Progressive disease on or after the first-line treatment for SCLC.\n* ECOG Performance Status 2.\n* Age ≥18 years.\n* Adequate haematological, renal and liver function.\n* Coagulation function: Prothrombin time (PT)\u002Finternational normalised ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5x ULN, except for patients receiving anticoagulation, who must be on a stable dose of anticoagulation therapy for 6 weeks prior to enrolment.\n* Pulmonary function:\n\n  * No clinically significant pleural effusion. Pleural effusion managed with indwelling pleural catheter (e.g., PleurX) are allowed.\n  * Baseline oxygen saturation \\>90% on room air.\n* Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan (preferred), and no clinically significant electrocardiogram (ECG) findings.\n* Women of childbearing potential, must have a negative urinary or serum pregnancy test within 5 weeks before enrolment. Pregnancy test must be repeated within 3 days before the first dose of tarlatamab treatment.\n* Written Informed Consent must be signed and dated by the patient and the investigator prior to any trial-related intervention.\n\nExclusion Criteria:\n\n* Symptomatic CNS metastases Patients with untreated asymptomatic brain metastases and patients with treated and stable brain metastases are eligible.\n* Diagnosis or evidence of leptomeningeal disease or spinal cord compression\n* Prior history of immune-checkpoint inhibitor treatment resulting in:\n\n  * any severe or life-threatening immune-mediated adverse event,\n  * history of immune-mediated encephalitis or another immune-mediated CNS event (any grade),\n  * grade ≥2 immune-mediated recurrent pneumonitis,\n  * infusion-related reactions leading to permanent discontinuation of the immunotherapy agent.\n\nException: patients with a history of immune-checkpoint inhibitor-induced endocrinopathy which is clinically stable on replacement therapy.\n\n* Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.\n* History of solid organ transplantation.\n* Treatment with live virus, including live-attenuated vaccination within 14 days prior to enrolment and inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 3 days prior to enrolment.\n* History of other malignancy within the past 2 years, with the following exceptions:\n\n  * Low-risk malignancy treated with curative intent and with no known active disease present for ≥1 year before enrolment and believed to be at low risk for recurrence per investigator discretion.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated cervical carcinoma in situ without evidence of disease.\n  * Adequately treated breast ductal carcinoma in situ without evidence of disease.\n  * Prostatic intraepithelial neoplasia without evidence of prostate cancer.\n  * Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ.\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\>class II) within 12 months prior to enrolment.\n* History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 12 months prior to enrolment.\n* Presence\u002Fhistory of an uncontrolled viral infection:\n\n  * Known uncontrolled human immunodeficiency virus (HIV) infection.\n  * Active hepatitis C infection (patients with detectable hepatitis C antibody \\[HCV Ab\\] and HCV RNA viral load above the limit of quantification).\n  * Patients with presence of HCV Antibodies and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed.\n  * Active hepatitis B infection (presence of hepatitis B surface antigen \\[HBsAg\\] and hepatitis B virus \\[HBV\\] DNA viral load above the limit of quantification \\[HBV DNA positive\\]).\n  * Patients with resolved HBV infection defined as absence of HBsAg and presence of HBV core antibody (anti-HBc) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n  * Patients with chronic HBV infection inactive carrier state defined as presence of HBsAg and HBV DNA viral load below the limit of quantification \\[HBV DNA negative\\] are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n* Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of study treatment.\n\n  * Prophylactic dexamethasone for the management of tarlatamab-related adverse events and any anti-emetic therapies are allowed.\n  * Low-dose corticosteroids (prednisone ≤10 mg per day or equivalent) is permitted during the trial.\n* Patients 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 study treatment.\n\n  * Patient has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the patient may be considered eligible for the study from an infection standpoint.\n  * Note: Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile for \\>24 hours, have no leucocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as exclusion criteria.\n* Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* Major surgical procedures within 5 weeks prior to enrolment.\n* Any concurrent medical condition which, in the opinion of the investigator, would compromise patient safety or interfere with the evaluations for tarlatamab.\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.\n* Women who are pregnant or in the period of lactation.\n* Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial until at least 60 days after the last dose of tarlatamab treatment.","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","START-lung is an international, multicentre, single-arm phase II trial. Protocol treatment consists of tarlatamab administered as an intravenous infusion until disease progression according to RECIST v1.1 criteria, unacceptable toxicity, or patient decision, whichever comes first. The primary objective of the trial is to assess the clinical efficacy of tarlatamab, in terms of 12-month OS rate, in patients with ES-SCLC and ECOG PS 2 who have previously received only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition and whose disease has progressed.",[27],"Extensive Stage Lung Small Cell Cancer",[29,30],"ES-SCLC","Tarlatamab","RECRUITING","2026-06-18",{"date":34,"type":35},"2026-06-22","ACTUAL",{"date":37,"type":35},"2026-04-15",{"date":39,"type":21},"2029-10",{"name":41,"class":42},"ETOP IBCSG Partners Foundation","NETWORK",19,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100587694","phase-3-a-clinical-study-to-assess-the-efficacy-of-adjuvant-immunotherapy-with-cemiplimab-in-patients-with-surgically-removed-non-small-cell-lung-cancer-who-have-not-received-prior-chemotherapy-100587694","NCT06931717","A Clinical Study to Assess the Efficacy of Adjuvant Immunotherapy With Cemiplimab in Patients With Surgically Removed Non-small Cell Lung Cancer Who Have Not Received Prior Chemotherapy","A Randomised Phase III Trial of Adjuvant Cemiplimab in Patients With Resected Stage II-IIIA NSCLC Who Have Not Received Prior Adjuvant Chemotherapy","ARCH","Inclusion Criteria:\n\n* Pathological stage II-IIIA (UICC\u002F AJCC staging 9th edition) NSCLC Brain imaging should have been performed to complete staging, either preoperatively or postoperatively. If brain imaging has not been performed, a contrast-enhanced CT or MRI of the brain must be performed at screening prior randomisation.\n* Complete resection with negative surgical margins (R0).\n\n  * Acceptable types of surgical resection include any of the following:\n* Lobectomy, sleeve lobectomy, bilobectomy, or pneumectomy.\n* Segmentectomy for tumours ≤2 cm is permitted in patients with poor pulmonary reserve or another major comorbidity that contraindicates lobectomy.\n\n  * Wedge resection is not allowed.\n  * Lymph node dissection should be done according to applicable guidelines.\n  * No disease recurrence following surgical resection.\n* Tumour PD-L1 expression of ≥1%, determined locally using a locally approved immuno-histochemistry test.\n* Availability of archival FFPE tumour tissue for central PD-L1 expression testing.\n* Patient is not considered for adjuvant platinum-based chemotherapy due to:\n\n  * Documented patient refusal; or\n  * Patient is unfit to receive adjuvant platinum-based chemotherapy (per investigator assessment) due to:\n\nECOG PS2, or ECOG PS 0\u002F1 and aged ≥70 years with substantial comorbidities or other contraindication(s) to platinum-based doublet chemotherapy.\n\n* Estimated life expectancy of ≥3 months.\n* Age ≥18 years.\n* Patient has recovered from surgery-related complications.\n* Adequate haematological, renal and liver function.\n* Patient is able to comply with the trial protocol, in the investigator's judgment.\n* Negative pregnancy test Female participants of childbearing potential (including women who had their last menstruation in the last 2 years), must have a negative serum pregnancy test within 5 weeks before randomisation. Pregnancy test must be repeated within 3 days before the first dose of protocol treatment and at every treatment visit (urine beta HCG test is sufficient).\n* Use of highly effective contraceptive methods Female participants of childbearing potential (including women who had their last menstruation in the last 2 years) and male participants with a female partners of childbearing potential must agree to use a highly effective method of contraception for the duration of the protocol treatment and until 4 months after the last dose of cemiplimab.\n* Written Informed Consent must be signed and dated by the patient and the investigator prior to any trial-related intervention.\n\nExclusion Criteria:\n\n* EGFR-mutant or ALK-rearranged NSCLC.\n* Any small cell component\n* Prior neoadjuvant and\u002For adjuvant systemic treatment for NSCLC.\n\nNote: Previous treatment for another malignancy not excluded as per next criterion (Participating in another interventional clinical trial for NSCLC) is allowed if the below conditions are fulfilled:\n\n* Treatment with an approved systemic therapy is completed \\>4 weeks before randomisation or\n* Treatment with systemic biologic therapy is completed \\>5 half-lives before randomisation and patient has recovered from any immune-mediated adverse events and endocrinopathies are adequately managed with hormone replacement.\n\n  * Participating in another interventional clinical trial for NSCLC.\n  * Diagnosis with another malignancy other than NSCLC that is progressing or requires active treatment.\n\nExceptions:\n\n* Non-melanoma skin cancer that has undergone potentially curative therapy\n* In situ cervical carcinoma\n* Any tumour that has been deemed to be definitively treated, such as definitively treated non-metastatic prostate cancer.\n\n  * Has any condition requiring ongoing\u002Fcontinuous corticosteroid therapy (\\>10 mg prednisone\u002Fday or anti-inflammatory equivalent) within 1 week prior to randomisation. Physiologic replacement doses are allowed even if they are \\>10 mg of prednisone per day or equivalent, as long as they are not being administered for immunosuppressive intent. Inhaled or topical steroids are permitted, provided that they are not for treatment of an autoimmune disorder.\n\nNote: Patients who require a brief course of steroids (ex. 3 days in the week before randomisation) or physiologic replacement are allowed to be included in the study.\n\n* Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.\n\nThe following are not exclusions: vitiligo, childhood asthma that has resolved, endocrinopathies (such as hypothyroidism or type 1 diabetes) that require only hormone replacement, or psoriasis that does not require systemic treatment.\n\n* Encephalitis, meningitis, organic brain disease (e.g., Parkinson's disease) or uncontrolled seizures within 1 year prior to randomisation.\n* Myocardial infarction within 6 months prior to randomisation.\n* Known history of, or any evidence of, interstitial lung disease or active, non-infectious pneumonitis within 5 years prior to randomisation.\n* Uncontrolled infection with HIV, hepatitis B, or hepatitis C infection; or the patient has a diagnosis of immunodeficiency.\n\n  * Patients with known HIV infection who have controlled infection \\[undetectable viral load (HIV RNA PCR) and CD4 count above 350 either spontaneously or on a stable antiviral regimen\\] are allowed to be included in the study. Patients with controlled HIV infection should be monitored according to local standards.\n  * Patients with hepatitis B (HBsAg+) with controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection and receiving antiviral therapy for hepatitis B) may be included in the study. Patients with controlled infection must undergo regular monitoring of HBV DNA. Patients must remain on antiviral therapy for at least 6 months after the last dose of cemiplimab.\n  * Patients who are hepatitis C virus antibody positive (HCV Ab+) with controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be included in the study.\n* Any infection requiring hospitalisation or treatment with intravenous anti-infectives within 2 weeks before randomisation.\n* Receipt of a live vaccine within 28 days before randomisation.\n* Receipt of a COVID-19 vaccination within 1 week before randomisation.\n* Prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation within 12 weeks before randomisation.\n* Known or suspected hypersensitivity to cemiplimab or its excipients.\n* Women who are pregnant, planning to become pregnant or are in the period of lactation.\n* Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.\n* Patients who are, or have an immediate family member who is, a member of the clinical study team, unless prior approval has been obtained from the sponsor (ETOP IBCSG Partners Foundation).\n* Judgement by the investigator that the patient is unlikely to comply with study procedures, restrictions and requirements.",{"count":53,"type":21},390,[55],"PHASE3","ARCH is a randomised, stratified, multicentre, phase III trial. Protocol treatment consists of cemiplimab, 350 mg i.v., every 3 weeks, for 4 cycles, followed by 700 mg i.v., every 6 weeks for 6 cycles or until relapse or unacceptable toxicities, whichever occurs first. The primary objective of the study is to determine the efficacy of adjuvant cemiplimab, as measured by disease-free survival, in patients without prior adjuvant platinum-based chemotherapy, compared to observation without adjuvant treatment. The primary objective will be assessed in patients with tumours with centrally confirmed PD-L1 expression of ≥1%.",[58],"Non-Small Cell Lung Cancer",[60,61],"NSCLC","Stage II-IIIA NSCLC",{"date":34,"type":35},{"date":64,"type":35},"2026-01-12",{"date":66,"type":21},"2029-03",{"name":41,"class":42},35,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100494449","phase-2-niraparib-added-to-anti-pd-l1-antibody-maintenance-in-slfn11-positive-extensive-disease-sclc-100494449","NCT05718323","Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC","A Single-arm Phase II Trial of the Addition of Niraparib to Anti-PD-L1 Antibody Maintenance in Patients With SLFN11-positive, Extensive-disease Small Cell Lung Cancer.","RAISE","Inclusion Criteria:\n\nInclusion criteria for SLFN11-expression testing\n\n* Written IC part 1: for SLFN11-screening must be signed and dated by the patient and the investigator prior to sending any tumour material to the central laboratory.\n* Histologically or cytologically confirmed ED-SCLC (stage IV according to the 8th TNM classification).\n* Availability of FFPE tumour tissue for screening.\n\nInclusion criteria for trial participation\n\n* Written IC part 2: for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention.\n* High SLFN11-expression on FFPE tumour material:\n\nSLFN11-expression is determined at the central screening laboratory in Basel. Overexpression is defined as detectable protein expression by IHC in ≥20% of tumour cells.\n\n* Patients must have received standard first-line chemo-immunotherapy, consisting of 4 cycles of platinum-etoposide chemotherapy in combination with an anti-PD-L1 antibody (atezolizumab or durvalumab). Patients who started the immunotherapy at chemotherapy cycle 2 are eligible.\n* ED-SCLC must not have progressed during or after standard chemo-immunotherapy (as per RECIST v1.1).\n* Patients must be candidates for ongoing maintenance treatment with immune-checkpoint inhibition.\n* Adequate haematological function:\n* Adequate renal function:\n* Adequate liver function:\n* ECOG PS 0-2\n* Age ≥18 years\n* Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 4 weeks before enrolment and within 3 days before treatment start.\n\nExclusion Criteria:\n\n* Symptomatic brain metastases\n* Any clinically active cancer, other than SCLC Exception: malignancies with negligible risk of metastases or death (e.g. 5-year OS rate of \\>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or stage I uterine cancer. Hormonal therapy for non-metastatic prostate or ductal carcinoma in situ is allowed.\n\nConsolidating thoracic radiotherapy. Palliative radiotherapy to the brain or to bones is allowed.\n\n* History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan.\n* Any lung disease requiring systemic steroids in doses of \\>10 mg prednisolone (or equivalent dose of other steroid).\n* Any serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) which in the opinion of the investigator would compromise the patient's ability to complete the trial or interfere with the evaluation of the efficacy and safety of the protocol treatment.\n* Inadequately controlled hypertension, defined as systolic blood pressure \\>150 mmHg and\u002For diastolic blood pressure \\>95 mmHg.\n\nThe patient must be considered stable and hypertension medically controlled.\n\n* History of myelodysplastic syndrome\u002Facute myeloid leukemia (MDS\u002FAML).\n* Prior Reversible Encephalopathy Syndrome (PRES)\n* Severe renal or hepatic impairment.\n* Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and\u002For bowels.\n* Treated with live vaccine within 30 days before enrolment.\n* Hypersensitivity to niraparib or any of its excipients (e.g., tartrazine).\n* Women who are pregnant or in the period of lactation.\n* Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial and within the required timelines after last dose of niraparib treatment.\n* Judgment by the investigator that the patient is unlikely to comply with trial procedures, restrictions and requirements.",{"count":78,"type":21},44,[24],"RAISE is an international, multicentre, single-arm phase II trial. The trial treatment consists of the addition of niraparib, 200 mg orally once daily to anti-PD-L1 antibody maintenance. The primary objective of this trial is to assess the clinical efficacy of the addition of niraparib to anti-PD-L1 monoclonal antibody maintenance treatment in patients with SLFN11-positive ED-SCLC which has not progressed following standard first-line chemo-immunotherapy.",[82,83],"SCLC,Extensive Stage","SLFN11-positive","2026-05-27",{"date":86,"type":35},"2026-05-29",{"date":88,"type":35},"2023-12-20",{"date":90,"type":21},"2027-06",{"name":41,"class":42},18,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100537937","phase-3-a-study-to-evaluate-the-benefit-of-adding-durvalumab-after-chemotherapy-durvalumab-and-surgery-in-patients-with-early-stage-operable-non-small-cell-lung-cancer-100537937","NCT06284317","A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.","An International, Multicentre, Open-label Randomised Phase III Trial to Evaluate the Benefit of Adding Adjuvant Durvalumab After Neoadjuvant Chemotherapy Plus Durvalumab in Patients With Stage IIB-IIIB (N2) Resectable NSCLC","ADOPT-lung","Inclusion Criteria for enrolment:\n\n* Histologically confirmed NSCLC.\n* Stage IIB-IIIB (T1-4 N0-2) according to 8th edition of the TNM staging system of lung cancer.\n\nStage III assessment should include samples of lymph nodes at levels 4, bilaterally, and level 7 to rule out stage IIIB N3 disease.\n\nT4 tumours will only be eligible if they are defined as T4 based only on their size (\\>7cm); any other reason will be considered ineligible.\n\n* Known PD-L1 status, as tested locally using a validated assay. To ensure comparability of results, it is strongly encouraged that PD-L1 testing is done with the Ventana PD-L1 (SP263) assay.\n* Absence of EGFR mutation or ALK translocation, as tested locally.\n* Primary tumour resectable and functionally operable as assessed per local multidisciplinary tumour board (cardiac evaluation, pulmonary function and diffusion capacity, comorbidity).\n* Adequate haematological function:\n\nHaemoglobin ≥90 g\u002FL, Absolute neutrophil count (ANC) ≥1.0× 109\u002FL, Platelet count ≥75× 109\u002FL.\n\n\\- Adequate renal function: Measured creatinine clearance (CL) \\>40 mL\u002Fmin or calculated CL \\>40 mL\u002Fmin calculated by the Cockcroft-Gault.\n\n\\- Adequate liver function: ALT and AST ≤2.5× institutional ULN, Total serum bilirubin ≤1.5× institutional ULN (patients with Gilbert's syndrome may be allowed to be enrolled after consultation with the Medical Affairs Team at the ETOP IBCSG Partners Foundation.\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Age ≥18 at the time of enrolment.\n* Body weight \\>30 kg.\n* Life expectancy of at least 12 weeks.\n* Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test at screening before enrolment. Pregnancy test must be repeated within 3 days before the first dose of protocol treatment.\n* Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.\n\nEligibility Criteria for randomisation:\n\n* Surgical resection must have been completed. Note: Participants who have had only had segmentectomy or wedge resections are not eligible for randomisation.\n* Patients must have complete resection: R0 or R1 resection.\n* Patients must be fit to receive adjuvant treatment with durvalumab.\n* Patients must have no evidence of metastatic disease as assessed by CT scan.\n* Documentation of pathological response as per local review must be available.\n\nExclusion Criteria for enrolment:\n\n* T4 with invasion of heart, great vessels, carina, trachea, oesophagus, or spine.\n* Any previous or concurrent treatments for NSCLC.\n* Any previous immunotherapy.\n* Major surgical procedure (as per investigators assessment) within 28 days before enrolment.\n* History of allogenic organ transplantation.\n* Active or prior documented autoimmune disease or inflammatory disorders (including inflammatory bowel disease \\[e.g., colitis or Crohn's disease\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.\\]). The following are exceptions to this criterion:\n\nPatients with vitiligo or alopecia. Patients with type I diabetes. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement.\n\nAny chronic skin condition that does not require systemic therapy. Patients without active disease in the last 5 years may be included but only after consultation with the Medical Affairs Team at the ETOP IBCSG Partners Foundation.\n\nPatients with celiac disease controlled by diet alone.\n\n* Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease (ILD), or serious chronic gastrointestinal conditions associated with diarrhoea.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* History of another primary malignancy except for:\n\nMalignancy treated with curative-intent and with no known active disease 5 years before the first dose of durvalumab and of low potential risk for recurrence.\n\nAdequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n\nAdequately treated carcinoma in situ without evidence of disease.\n\n* History of leptomeningeal carcinomatosis.\n* History of active primary immunodeficiency.\n* Active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HbsAg) or HBV core antibody (anti-HBc).\n\nParticipants with a past or resolved HBV infection (defined as the presence of anti-HBc and absence of HbsAg) are eligible.\n\nParticipants positive for HCV antibody are only eligible if polymerase chain reaction is negative for HCV RNA.\n\n* Known HIV infection that is not well-controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load for 3 months, CD4+ count of 500 cell per mm3, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 3 months on the same anti-HIV medication.\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:\n\nIntranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection).\n\nSystemic corticosteroids at physiologic doses not exceeding 10 mg\u002Fday of prednisone or its equivalent.\n\nSteroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n\n\\- Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab.\n\nNote: Patients in the ADOPT-lung trial, should not receive live vaccine whilst receiving durvalumab and for up to 30 days after the last dose.\n\nConcurrent enrolment in another interventional clinical trial.\n\n* Known allergy or suspected hypersensitivity to durvalumab or its excipients.\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.\n* Female patients who are pregnant or in the period of lactation.\n* Female patients of childbearing potential and sexually active men who are not willing to use a highly effective contraceptive method during the trial until at least 90 days after the last dose of protocol treatment.",{"count":102,"type":21},290,[55],"ADOPT-lung is an international, multicentre, open-label randomised phase III trial. Protocol treatment consists of 3-4 cycles of neoadjuvant durvalumab in combination with platinum-based doublet chemotherapy, followed by surgery. Patients with R0 and R1 only resection will be randomised to receive either adjuvant durvalumab for 12 cycles (experimental arm) or observation (control arm). The primary objective of the study is to determine whether additional adjuvant immunotherapy with durvalumab after neoadjuvant chemo-immunotherapy has an effect on disease-free survival (DFS) in patients who do not achieve complete pathological response (pCR) as per local assessment according to the IASLC recommendations.",[106],"Non Small Cell Lung Cancer",[108,109],"IIB-IIIB (N2) resectable NSCLC","Durvalumab","2026-05-12",{"date":112,"type":35},"2026-05-14",{"date":114,"type":35},"2025-01-15",{"date":116,"type":21},"2030-03",{"name":41,"class":42},42,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},"100479413","phase-3-immunotherapy-or-targeted-therapy-with-or-without-stereotactic-radiosurgery-for-patients-with-brain-metastases-from-melanoma-or-non-small-cell-lung-cancer-100479413","NCT05522660","Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer","A Multicentre Randomised Open-label Phase III Study of Stereotactic Radiosurgery, in Addition to Standard Systemic Therapy for Patients With Metastatic Melanoma or Newly Diagnosed Metastatic NSCLC and Asymptomatic or Oligo-symptomatic Brain Metastases","USZ-STRIKE","Most important inclusion criteria:\n\n* Newly diagnosed, previously untreated (except for surgery, see below) asymptomatic or oligo-symptomatic brain metastases, e.g., controlled symptomatic seizure disorder. Note: patients with neurological symptoms or signs that require more than a stable dose of 4 mg dexamethasone equivalent for more than one week are not considered oligo-symptomatic.\n* Requirements for brain metastases:\n* Brain metastases must be previously untreated, except for surgery.\n* Prior surgery (including biopsies, resection, and cyst aspiration) for brain metastases is allowed. Residual and measurable disease after surgery is not required, but surgery must have confirmed the diagnosis. An MRI performed within 72 hours post-surgery should be available.\n* Number and size of metastases at diagnosis of brain metastases:\n\n  * Maximum 1-10 brain metastases at screening\n  * At least one brain metastasis must be of ≥5 mm in diameter\n  * In case of 1-4 brain metastases:\n  * Longest diameter of largest brain metastasis must be ≤30 mm\n  * In case of 5-10 brain metastases:\n  * Largest metastasis must be ≤10 mL in volume and longest diameter must be ≤30 mm\n  * Maximum cumulative brain metastases volume must be ≤30 mL\n* Primary disease of histologically confirmed (from primary tumour or from a metastatic lesion, including in the brain) melanoma or NSCLC\n* Requirements for patients with melanoma:\n* Prior treatment, including treatment with immune-checkpoint inhibitors is permitted, but brain metastases must be newly diagnosed and previously untreated (except for surgery).\n* BRAF-mutation status, locally assessed, should be known (previous adjuvant BRAF-targeted therapy is allowed).\n* Requirements for patients with NSCLC:\n* Newly diagnosed, treatment-naïve (except for prior surgery) metastatic NSCLC, with or without a targetable oncogenic driver alteration.\n* Known PD-L1 expression status (from primary tumour or from a metastatic lesion, including brain)\n* Known driver mutation status (from primary tumour or from a metastatic lesion, including brain).\n* Age of 18 years or older\n* Karnofsky performance status of 60 or more\n* Life expectancy \\>12 weeks\n* Patients must be candidates for systemic treatment, within the defined cohorts (melanoma: cohorts 1a and 1b; NSCLC: cohorts 2a and 2b).\n* Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 7 days before randomisation.\n* Written IC for study participation must be signed and dated by the patient and the investigator prior to any study-related intervention.\n\nMost important exclusion criteria:\n\n* Confirmed or probable leptomeningeal metastases according to EANO ESMO criteria\n* Symptomatic brain metastases at time of randomisation, e.g., neurological symptoms or signs that require more than a stable dose of 4 mg dexamethasone equivalent for more than one week.\n* Patients must be off steroids or on a stable dose of ≤4 mg dexamethasone equivalent at randomisation.\n* Patients experiencing seizures controlled by anti-epileptic drugs are eligible.\n* Prior whole brain irradiation or focal radiation therapy to the brain\n* Prior systemic treatment for brain metastases\n* Contra-indication for SRS\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Women who are pregnant or in the period of lactation.\n* Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.",{"count":128,"type":21},180,[55],"The primary objective of the study is to assess the efficacy in terms of CNS-specific PFS of the combination of standard systemic treatment plus SRS vs. standard systemic treatment alone in patients with newly diagnosed and untreated (except for surgery) asymptomatic or oligosymptomatic brain metastases from melanoma or NSCLC. This proposed randomised phase III clinical study addresses one of the most controversial issues in the current approach to patients with brain mets: the timing of SRS in patients eligible for systemic immune checkpoint inhibition or targeted therapy in order to guide therapeutic options as to what strategy allows the best compromise between best survival and best QoL.",[58,132],"Melanoma","2026-04-22",{"date":135,"type":35},"2026-04-27",{"date":137,"type":35},"2022-11-30",{"date":139,"type":21},"2026-12",{"name":41,"class":42},15,""]