[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-cell-lung-carcinoma-sclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-cell-lung-carcinoma-sclc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,72],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100593506","early-phase-1-evaluation-of-the-value-of-68gaga-pentixafor-pet-ct-in-patients-with-metastatic-small-cell-lung-cancer-sclc-100593506",false,"NCT07007325","Evaluation of the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung Cancer (SCLC)","Prospective Feasibility Pilot Study Evaluating the Value of [68Ga]Ga-PENTIXAFOR PET-CT in Patients With Metastatic Small Cell Lung Cancer (SCLC) at Diagnosis and Disease Progression","PASSIFLORE","Inclusion Criteria:\n\n1. Written informed consent signed before performing any trial specific procedure.\n2. Male or female, age ≥ 18 years at time of study entry.\n3. Patient with histologically proven small cell lung carcinoma, inoperable, non-pre-treated.\n4. Metastatic disease documented by conventional imaging and\u002For \\[18F\\]FDG PET-CT with at least one metastatic measurable lesion (RECIST 1.1). Patients eligible for 1st line metastatic treatment.\n5. Availability of tissue material (primary lesion and\u002For metastatic site) to allow additional immunohistochemical studies.\n6. PS \\\u003C 2.\n7. Consent to use a contraception method for at least 3 months after each administration of \\[68Ga\\]Ga-PentixaFor.\n8. Adequate Organ function confirmed by laboratory test results allowing for safe the \\[68Ga\\]Ga-PentixaFor administration.\n9. Life expectancy greater than 3 months.\n10. Patient has valid health insurance.\n11. Patient willing and able to comply with the protocol throughout the duration of the study, including during treatment and scheduled visits and examinations, including follow-up.\n\nExclusion Criteria:\n\n1. History of cancer in the 3 years prior to entry into the trial other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n2. History of anti-cancer treatments such as chemotherapy, radiotherapy or immunotherapy as well as other clinical trials for SCLC before the first \\[68Ga\\]Ga-PentixaFor PET-CT imaging.\n3. Inability to lie still for at least 1 hour, or known claustrophobia.\n4. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic) which may interfere with study objectives or patient safety or compliance, in the judgment of the investigator.\n5. Unstable diabetes with blood glucose \\> 2 g\u002FL.\n6. Known hypersensitivity to any active pharmaceutical agent or constituent of the \\[68Ga\\]Ga-PentixaFor and\u002For \\[18F\\]FDG product.\n7. Body weight of less than 48 kg.\n8. Mental impairment that may compromise the ability to give informed consent and comply with study requirements.\n9. Pregnant, likely to be pregnant or breastfeeding woman.\n10. Patient deprived of liberty, under judicial safeguard, under curatorship or placed under the authority of a guardian.\n11. Disorder preventing understanding of trial information or informed consent.","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","\\[68Ga\\]Ga-PentixaFor PET-CT will be performed in patients with Small cell lung cancer (SCLC) to confirm the targeting of CXCR4 by \\[68Ga\\]Ga-PentixaFor",[27],"Small Cell Lung Carcinoma (SCLC)",[27,29,30,31,32,33],"[68Ga]Ga-PentixaFor","immunohistochemistry (IHC)","CXCR4 expression","[18F]FDG","Safety","NOT_YET_RECRUITING","2026-06-16",{"date":37,"type":38},"2026-06-18","ACTUAL",{"date":40,"type":21},"2026-09-30",{"date":42,"type":21},"2030-09-30",{"name":44,"class":45},"Institut Cancerologie de l'Ouest","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100513315","phase-1-a-study-to-test-how-bi-764532-is-taken-up-by-tumours-in-people-with-small-cell-lung-cancer-or-neuroendocrine-cancer-100513315","NCT05963867","A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer","An Open-label Phase 1 PET Imaging Trial to Investigate [89Zr]Zr-BI 764532 Biodistribution and Tumour Uptake in Patients With Small-cell Lung Carcinoma or Neuroendocrine Carcinoma","Inclusion Criteria:\n\n* Age ≥18 years\n* Weight ≥ 60kg\n* Signed and dated, written informed consent form (ICF) in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.\n* Patient who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. Previous therapies should include at least one line of platinum-based chemotherapy. Previous therapy with anti Programmed Cell Death Protein 1 (PD-1) or Programmed Cell Death Ligand 1 (PD-L1) are allowed.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* At least one evaluable lesion outside of Central Nervous System (CNS) as defined per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1\n* Subjects with brain metastases are eligible provided they meet the following criteria:\n\n  * radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 764532,\n  * patient is off steroids for at least 7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for at least 7 days or on stable doses of anti-epileptic drugs for malignant CNS disease.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:\n\n  * effectively treated non-melanoma skin cancers\n  * effectively treated carcinoma in situ of the cervix\n  * effectively treated ductal carcinoma in situ\n  * other effectively treated malignancy that is considered cured by local treatment\n* Major injuries and\u002For surgery or bone fracture within 28 days of first dose BI 764532, or planned surgical procedures\n* Known leptomeningeal disease or spinal cord compression due to metastatic disease\n* Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed\n* Active infection that requires medical therapy or other clinically significant intervention\n* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 2 weeks prior to study entry (confirmed via polymerase chain reaction (PCR) test or other applicable test as per local requirements) or suspected SARS-CoV-2 infection as per physician assessment, or close contact (within 1 week) with an individual with confirmed SARS-CoV-2 infection\n* Any of the following known laboratory evidence of hepatitis virus infection:\n\n  * Positive results of hepatitis B surface (HBs) antigen\n  * Presence of hepatitis B core (HBc) antibody together with hepatitis B virus DNA (HBV-DNA)\n  * Presence of hepatitis C ribonucleic acid (RNA)\n* Known human immunodeficiency virus (HIV) infection. Further exclusion criteria apply.",{"count":54,"type":21},12,[56],"PHASE1","This study is open to adults with small cell lung cancer and other neuroendocrine cancers. The study is in people with advanced cancer for whom previous treatment was not successful or no standard treatment exists. The purpose of this study is to find out how a medicine called BI 764532 gets distributed in the body and in tumours.\n\nParticipants get BI 764532 when starting treatment. In the first weeks, doctors check how BI 764532 is taken up in tumours by means of an imaging method. If there is benefit for the participants and if they can tolerate it, the treatment is given up to the maximum duration of the study. During this time, participants visit the study site regularly. The total number of visits depends on how they respond to and tolerate the treatment. Doctors record any unwanted effects and regularly check the general health of the participants.",[27,59],"Neuroendocrine Neoplasms","RECRUITING","2026-05-07",{"date":63,"type":38},"2026-05-08",{"date":65,"type":38},"2024-08-06",{"date":67,"type":21},"2026-11-25",{"name":69,"class":70},"Boehringer Ingelheim","INDUSTRY",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100585437","phase-1-safety-pharmacokinetics-and-preliminary-efficacy-of-cs231295-in-advanced-solid-tumors-100585437","NCT06902350","Safety, Pharmacokinetics and Preliminary Efficacy of CS231295 in Advanced Solid Tumors","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CS231295 in Subjects With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Understand and sign the informed consent form voluntarily.\n2. ≥18 years old when signing the informed consent, regardless of sex.\n3. Have histologically or cytologically confirmed unresectable advanced, recurrent, or metastatic solid tumors (including but not limited to small cell lung cancer, glioblastoma, urothelial carcinoma, endometrial cancer, cervical cancer, ovarian cancer, breast cancer, and liver cancer) for which standard therapy has failed or was intolerable, and currently no standard treatment is available.\n\n   * Radiological or histopathological evidence indicating disease progression should be documented.\n   * Intolerance is defined as discontinuation of treatment due to adverse events during therapy.\n   * Recurrence is based on radiological or histopathological results.\n4. For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. Note: Target lesions can be located in previously irradiated areas, but must be confirmed by imaging to show disease progression after radiation.\n5. For glioblastoma: KPS score ≥60. For other solid tumors: ECOG performance status of 0 or 1.\n6. Meet the following laboratory criteria (without receiving any blood products, hematopoietic growth factors, albumin, or other treatments within 14 days prior to testing, except iron supplements):\n\n   * Hematology: Hemoglobin (Hb) ≥100 g\u002FL, absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet (PLT) count ≥100×10\\^9\u002FL.\n   * Biochemistry: 1) Dose escalation phase: Serum creatinine (Cr) ≤ upper limit of normal (ULN); total bilirubin (TBIL) ≤1.25×ULN; alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤1.5×ULN (for subjects with liver metastases or hepatocellular carcinoma: ≤3×ULN). 2) Cohort expansion phase: Cr ≤1.5×ULN; TBIL ≤1.5×ULN; ALT, AST ≤2.5×ULN (for subjects with liver metastases or hepatocellular carcinoma: ≤5×ULN).\n   * Coagulation: International normalized ratio (INR) ≤1.5×ULN; prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN (for participants receiving prophylactic anticoagulation, the INR and APTT should be within a safe and effective therapeutic range as judged by the investigator).\n   * Urinalysis: Urine protein \\\u003C2+; if ≥2+, a 24-hour urine protein quantification should be performed. \\\u003C1 g\u002F24 h can be enrolled but ≥1 g\u002F24 h is prohibited. without quantification when urine protein ≥2+ is not allowed.\n7. Expected survival ≥12 weeks.\n8. Cohort Expansion Phase: 1) Cohort 1: Histologically or cytologically confirmed small cell lung cancer (SCLC) that has progressed or recurred after at least two lines of systemic chemotherapy (including a platinum-based regimen). Note: A new line of treatment is defined as a change in treatment due to disease progression, not due to toxicity or other reasons. Re-initiation of the same treatment regimen after initial progression is considered a new line of treatment. 2) Cohort 2: Recurrent or progressive glioblastoma confirmed by histopathology or imaging, which has progressed or recurred after at least one prior treatment with temozolomide.\n\nExclusion Criteria:\n\n1. Received any form of intracranial radiotherapy within 3 months prior to the first dose.\n2. Received any anti-tumor treatment (including but not limited to chemotherapy, targeted therapy, immunotherapy, cellular therapy, radiation therapy \\[see exclusion criterion #1 for head\\], endocrine anti-tumor therapy, tumor embolization) or unapproved investigational drugs or devices within 28 days prior to the first dose. Also, received Traditional Chinese Medicine (TCM) approved by the National Medical Products Administration (NMPA) for treating malignant tumors within 14 days prior to the first dose.\n3. Previously received Aurora kinase inhibitors.\n4. Used strong inducers or inhibitors of cytochrome P450 3A (CYP3A) enzymes within 14 days prior to the first dose or are still within 7 half-lives of such drugs (whichever is longer).\n5. For glioblastoma only: \\>5 mg\u002Fday dexamethasone or equivalent doses of other glucocorticoids for systemic treatment related to glioblastoma within 1 week prior to the first dose.\n6. Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures as judged by the investigator at screening.\n7. Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1, except for alopecia or laboratory abnormalities deemed no clinical significant by the investigator.\n8. History of other primary malignancies within 5 years prior to the first dose, except for adequately treated in situ carcinoma, non-melanoma skin cancer, or malignant melanosis.\n9. For solid tumors other than glioblastoma: Unstable brain metastases. Stable brain metastases are allowed if:\n\n   * No immediate or planned local treatment for brain metastases during the study.\n   * No neurological symptoms or signs (e.g., increased intracranial pressure, seizures, cognitive impairment) at screening.\n   * Brain lesions stable for ≥2 weeks prior to the first dose without corticosteroid or anticonvulsant treatment.\n10. Leptomeningeal metastasis (except glioblastoma).\n11. Severe brain herniation or risk thereof.\n12. For glioblastoma only: who had wafer(s) implantation during surgery.\n13. Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms (e.g., chest tightness, shortness of breath, dyspnea).\n14. Uncontrolled or significant cardiovascular disease, including:\n\n    * NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to the first dose, or arrhythmias requiring treatment, left ventricular ejection fraction (LVEF) \\\u003C50% at screening.\n    * Primary cardiomyopathy (e.g., dilated, hypertrophic, arrhythmogenic right ventricular, restrictive, or unclassified cardiomyopathy).\n    * Symptomatic coronary artery disease requiring medication at screening.\n    * Clinically significant QTcF prolongation history or QTcF \\>470 ms (females) and \\>450 ms (males) at screening.\n    * Significant cerebrovascular accident (including cerebral hemorrhage, transient ischemic attack) within 6 months prior to the first dose.\n    * Use of ≥3 antihypertensive drug components within 14 days prior to the first dose or inadequately controlled blood pressure (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) at screening.\n    * Other cardiovascular conditions deemed unsuitable by the investigator.\n15. Poorly controlled diabetes (fasting glucose \\>10 mmol\u002FL).\n16. Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption (e.g., inability to swallow, chronic diarrhea, bowel obstruction, small bowel resection, or total gastrectomy).\n17. Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose (e.g., gastrointestinal bleeding); currently on anticoagulants (e.g., warfarin, phenprocoumon, but low-dose aspirin and heparin for prophylaxis allowed); high-risk bleeding tendency at screening (e.g., esophageal varices, active ulcerative lesions, positive occult blood in stool, imaging evidence of tumor invasion into large vessels).\n18. Serious thromboembolic events within 6 months prior to the first dose (e.g., arterial thrombosis, pulmonary embolism, deep vein thrombosis). Implanted venous port or catheter-related thrombi, superficial vein thrombi, or those deemed stable and not requiring emergency medical intervention are not considered \"serious.\"\n19. Active infection requiring intravenous treatment at screening. Severe infections (e.g., hospitalization due to infection, bacteremia, severe pneumonia complications) within 28 days prior to the first dose. Patients receiving prophylactic antibiotics (e.g., for urinary tract infections or COPD exacerbations) can be enrolled.\n20. Known active tuberculosis, currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to the first dose.\n21. Active hepatitis B (HBsAg or HBcAb positive with viral replication) or hepatitis C (HCV antibody positive with viral replication) at screening.\n22. Human immunodeficiency virus (HIV) infection or syphilis infection (positive specific antibody test followed by positive non-specific antibody test) at screening.\n23. Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.\n24. History of organ transplantation or allogeneic hematopoietic stem cell transplantation.\n25. History of alcohol abuse or drug abuse.\n26. Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.\n27. Unwilling or unable to use effective contraception methods during the entire treatment period and up to 3 months after the last dose for women of childbearing potential (defined as having experienced menarche and not undergone successful artificial sterilization \\[hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\\] or not postmenopausal) or male patients whose partners are women of childbearing potential; pregnant or breastfeeding women.\n28. Other conditions deemed unsuitable for participation in this trial by the investigator.",{"count":80,"type":21},102,[56],"This trial is a single-arm, open-label, first-in-human study of CS231295, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The Dose-Limiting Toxicity (DLT) observation period includes 6 days for single-dose and the first cycle (28 days) for multiple-dose. The overall study consists of screening period, treatment period, and follow-up period.\n\nThe primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS231295 in patients with advanced solid tumors, and to recommended Phase 2 dose(s) (RP2D) of CS231295 in appropriate tumor(s).",[84,85,27],"Neoplasms","Glioblastoma, Adult","2025-05-22",{"date":88,"type":38},"2025-05-25",{"date":90,"type":38},"2025-05-21",{"date":92,"type":21},"2029-04",{"name":94,"class":70},"Chipscreen Biosciences, Ltd.",2]