[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-small-cell-lung-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100568437","phase-1-biomarker-directed-trial-of-temozolomide-and-stenoparib-in-relapsed-sclc-100568437",false,"NCT06681220","Biomarker Directed Trial of Temozolomide and Stenoparib in Relapsed SCLC","Relapsed SCLC","Inclusion Criteria:\n\n* Age 18 years or older at the time of consent.\n* Histological or cytological diagnosis of extensive-stage small cell lung cancer.\n* Patients must have received one prior line of systemic therapy.\n\n  * Patients must have received first-line therapy with Carboplatin and Etoposide.\n\n    * If patient is re-treated with Carboplatin and Etoposide at least 6 months or more after first regimen, this will still be considered one line of\n    * treatment and they will qualify for this trial.\n  * Patients could have received immunotherapy in combination with the chemotherapy regimen.\n  * Patients who have received Tarlatamab as second line treatment are allowed.\n* ECOG Performance status 0-2.\n* Measurable disease as per RECIST v1.1 (NOTE: Previously irradiated lesions are eligible as a target lesion only if there is documented progression of the lesion after irradiation).\n* Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements:\n\n  * ANC 1.5\n  * Platelets 100 × 109\u002FL\n  * Hemoglobin 9 g\u002FdL or 5.6 mmol\u002FL\n  * Aspartate transaminase and alanine transaminase 2.5 × upper limit of normal (ULN), \\\u003C5× in patients with known liver metastases\n  * Serum total bilirubin 1.5 × ULN, 1.5-3.0 × ULN may be included appropriate starting dose adjustment to 200 mg daily.\n  * Creatinine \\\u003C1.5 × ULN or estimated glomerular filtration rate (GFR) 50 ml\u002Fmin by Cockcroft-Gault. Depending on scenario, GFR 30-49 can be --permissible.\n* Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test within 72 hours of cycle 1 Day 1.\n* Male and female subjects of child-bearing potential must agree to use a double-barrier method of birth control from the screening visit through 180 days after the last dose of study drug.\n* Male subjects of child-bearing potential must agree to use a double-barrier method of birth control including use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak) and must agree to refrain from donating sperm from screening visit through at least 90 days after the last dose of study drug.\n* Previously treated or asymptomatic brain metastases are allowed.\n\nExclusion Criteria:\n\n* Unstable or clinically significant concurrent medical condition, psychiatric illness or social situation that would, in the opinion of the investigator, jeopardize the safety of a subject and\u002For their compliance with the protocol.\n* Clinically significant acute infection requiring systemic antibacterial, antifungal, or antiviral therapy. (Suppressive therapy for chronic infections allowed, for example: Subjects with HIV\u002FAIDS with adequate antiviral therapy to control viral load would be allowed. Subjects with viral hepatitis with controlled viral load would be allowed while on suppressive antiviral therapy.)\n* Prior exposure to lurbinectedin, TMZ or stenoparib.\n* Pregnant or breastfeeding.\n* Clinical significant cardiovascular disease (ie active)\n* Subject with known hypersensitivity to Stenoparib components\n* Subject with known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) are excluded.\n* Subject with QTc interval 470 for females, or 450 for males per electrocardiogram (EKG) at screening.","ALL","18 Years",{"count":19,"type":20},166,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Randomized phase 2, multicenter, biomarker directed clinical trial with a safety lead-in to assess the efficacy of Stenoparib plus Temozolomide (TMZ) in relapsed Small Cell Lung Cancer patients. Participants will receive either a combination of oral Stenoparib at the highest tolerated dose with oral Temozolomide 40mg daily or standard of care Lurbinectedin for 21-day cycles. The Dose limiting toxicity period will be 1 cycle of 21 days. This study will explore if the biomarkers the investigators test predict sensitivity to the combination of Stenoparib plus TMZ and therefore leads to a better treatment response. There are two potential tests of biomarkers that can predict who would benefit from the oral combination of Stenoparib with Temozolomide (TMZ), but they have not been evaluated. This study will test for this sensitivity using a biomarker (found in the blood that may be related to how a person reacts to a drug). The study will include 9 participants for the safety evaluation of the Stenoparib+TMZ group and 5 participants for the standard of care Lurbinectedin safety group. We will first determine safety dose for the experiment arm which, will include 3 groups with 3 participants in each group. Three doses of Stenoparib will be evaluated for toxicity. The initial starting dose of Stenoparib will be 200mg po QD. Once the maximum tolerated dose has been determined, participants will be assigned to one of the two groups in the phase 2 portion. Group 1 will be patients that test negative for the biomarker and will receive treatment with Lurbinectedin as per standard of care guidelines. Group 2 will be patients that test positive for the biomarker that will be randomly assigned to either the combination of Stenoparib plus Temozolomide (TMZ) or Lurbinectedin.",[27,28],"Relapsed Small Cell Lung Cancer","Recurrent Small Cell Lung Cancer",[30,31,32],"Phase 2","Small Cell Lung Cancer","Biomarker","RECRUITING","2026-03-10",{"date":36,"type":37},"2026-03-11","ACTUAL",{"date":39,"type":37},"2026-02-23",{"date":41,"type":20},"2030-12-31",{"name":43,"class":44},"VA Office of Research and Development","FED",11,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100554204","phase-3-lurbinectedin-or-in-combination-with-irinotecan-versus-topotecan-in-patients-with-relapsed-sclc-100554204","NCT06496048","Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC","A Phase III, Multicenter, Randomized, Open-label Study of Lurbinectedin As Monotherapy or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed Small-cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n1. Being voluntary to sign the informed consent form, with good compliance with the study treatment regimen and visit schedule.\n2. Men or women ≥18 years of age.\n3. Histologically or cytologically confirmed SCLC.\n4. Life expectancy ≥12 weeks.\n5. Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2 (see Appendix I for the scoring criteria).\n6. One prior line of etoposide + platinum chemotherapy with\u002Fwithout anti-PD-1 or anti-PD-L1 (Note: at least 70% of the patients included in the study have to be pretreated with anti-PD-1 or anti-PD-L1)\n7. Chemotherapy-free interval (CTFI, i.e., the time from the last dose of first-line platinum-based chemotherapy to the occurrence of disease progression) ≥30 days.\n8. At least one measurable lesion (in accordance with RECIST 1.1 criteria).\n9. Adequate organ function as defined below:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL (Red blood cell transfusion is allowed to be given more than 2 weeks prior to enrollment if blood transfusion is clinically indicated); absolute neutrophil count ≥ 2.0 × 109\u002FL, and platelet count ≥ 100 × 109\u002FL.\n   2. Alanine aminotransferase and aspartate aminotransferase ≤ 3.0 × ULN.\n   3. Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ 1 × ULN.\n   4. Albumin ≥ 3.0 g\u002FdL.\n   5. Calculated creatinine clearance (CrCL) ≥ 40 mL\u002Fmin (using the Cockcroft-Gault formula, as detailed in Appendix IV).\n10. ≥ 3 weeks since the last anti-tumor therapy and recovery of adverse events (AEs) related to prior anti-tumor therapy to Grade ≤ 1, as judged by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE 5.0) (Except for anemia; and recovery to Grade ≤ 2 for sensory neuropathy, asthenia and alopecia).\n11. Female patients of childbearing potential must have a negative blood or urine pregnancy test prior to enrollment, and must accept to take highly effective contraceptive measures during the treatment with the investigational medicinal product and for 7 months after the last dose. Male patients with a female partner of childbearing potential must accept to take highly effective contraceptive measures during the treatment with the investigational medicinal product and for 4 months after the last dose.\n\nExclusion Criteria:\n\n1. Patients with central nervous system (CNS) metastases, unless that they have received corresponding treatment and have been shown by a repeated imaging examination to have stable disease (i.e., no evidence of disease progression) for at least 4 weeks (Note: the repeated imaging examination should be performed at screening), are asymptomatic, and do not need to receive steroid therapy within at least 7 days prior to the first dose of the investigational medicinal product.\n2. Platinum-naïve patients or patients pretreated with more than one prior chemotherapy regimen (including patients re-challenged with same initial regimen).\n3. Prior use of Lurbinectedin, Trabectedin, PM14 (Ecubebectedin), or topoisomerase I inhibitors (Irinotecan, Topotecan, etc.).\n4. Having received a strong or moderate CYP3A4 inhibitor within 2 weeks prior to the first dose of the investigational medicinal product (see Appendix III for details).\n5. Patients who have received prophylactic cranial irradiation (PCI) and radiotherapy (prophylactic and\u002For therapeutic) at other sites within 2 weeks prior to randomization.\n6. Patients with limited-stage disease who plan to receive local or regional treatment (including PCI, thoracic radiotherapy, or both) during the study (Note: patients with extensive-stage disease may receive radiotherapy during the study if they meet the requirements as described in Section 5.8.1).\n7. Patients who, at the screening visit, are about to receive radiotherapy, such as for painful bone metastasis and\u002For risk of spinal cord compression. Patients who have a history of bone marrow and\u002For stem cell transplantation and allogeneic transplantation.\n8. Having received a live vaccine or attenuated live vaccine within 30 days before the first dose of the investigation medicinal product (inactivated vaccines are allowed).\n9. Concomitant diseases:\n\n   1. Having unstable angina pectoris, myocardial infarction, congestive heart failure (CHF) of New York Heart Association (NYHA) class II or above, or clinically significant heart valve diseases within one year prior to screening.\n   2. Having symptomatic arrhythmia, or arrhythmia with unstable control and requiring continuous treatment at screening.\n   3. Patients requiring continuous oxygen inhalation within 2 weeks prior to randomization.\n   4. Patients with confirmed or suspected diffuse interstitial lung disease or pulmonary fibrosis.\n   5. Patients who have rapidly increasing pleural or pericardial effusion with significant symptoms, and\u002For need prompt local therapy within 7 days, at screening.\n   6. Hepatic cirrhosis with the Child-Pugh score (see Appendix II for the scoring criteria) of B or C.\n   7. Patients with Gilbert's disease.\n   8. Patients with persistent non-neoplastic chronic liver disease (of any etiology) requiring treatment, including those with positive hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer ≥ 500 IU\u002FmL, those with positive hepatitis C antibody and hepatitis C virus ribonucleic acid (HCV-RNA) titer ≥ 100 IU\u002FmL, and those having received hepatitis-related antiviral therapy within 6 months prior to the first dose of the investigational medicinal product.\n   9. Chronic inflammatory bowel disease or intestinal obstruction (including intestinal pseudo-obstruction, incomplete intestinal obstruction, enteroparalysis, etc.) in the past or at screening.\n   10. Patients with uncontrolled active infection who have received systemic intravenous anti-infective therapy within 1 week prior to randomization.\n   11. Having severe and uncured wounds, ulcers, fractures, and external drainage disposal at screening.\n   12. Patients with confirmed or suspected invasive fungal infection within 12 weeks prior to randomization who need systemic treatment.\n   13. Positive for human immunodeficiency virus (HIV) antibody at screening.\n   14. Patients with prior history of malignant tumors other than SCLC, except those who have undergone radical resection more than 3 years prior to randomization and have a sustained response after treatment (e.g., cervical carcinoma in situ, basal or squamous cell skin cancer, transitional cell bladder cancer in situ, etc.).\n   15. Any other major disease that, at the discretion of the investigator, can significantly increase the risk associated with participation in this study.\n10. Having a history of allergy or hypersensitivity to any of the investigational medicinal products or any of their excipients.\n11. Drug abuse, drug addiction or alcohol abuse (alcohol abuse is defined as drinking more than 14 units of alcohol per week within 3 months prior to signing the informed consent \\[1 unit = 350 mL of beer, or 45 mL of liquor, or 150 mL of wine\\]).\n12. Pregnant or lactating women and patients of childbearing age who cannot use highly effective contraceptive methods (regardless of gender) (see Inclusion Criterion #11).\n13. Those who cannot fully comply with the treatment plan or comply with the study protocol, as judged by the investigator.",{"count":54,"type":20},180,[56],"PHASE3","Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.",[27],"2024-12-09",{"date":61,"type":37},"2024-12-12",{"date":63,"type":37},"2024-09-14",{"date":65,"type":20},"2028-06-30",{"name":67,"class":68},"Luye Pharma Group Ltd.","INDUSTRY",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":69},"100525984","phase-3-study-of-ly01610-in-patients-with-recurrent-small-cell-lung-cancer-100525984","NCT06128837","Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer","A Multicenter, Randomized, Open-label, Parallel-design Phase 3 Study to Evaluate the Efficacy and Safety of LY01610 (Irinotecan Hydrochloride Liposome Injection) Versus Topotecan in Patients With Recurrent Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female;\n2. Patients with histologically and\u002For cytologically confirmed small cell lung cancer;\n3. Disease progression (CTFI ≥ 30 days and ≤ 6 months) occurred after at least 4 cycles of first-line etoposide + platinum two-drug chemotherapy-based treatment, regardless of whether the primary tumor was treated with radiotherapy; the stage of patients with limited stage SCLC should meet more than T1-2, N0, or not suitable for surgery;\n4. At least one evaluable lesion (according to RECIST 1.1 criteria);\n5. Expected survival time ≥ 3 months;\n6. Eastern Cooperative Oncology Group (ECOG) score \\\u003C 2;\n7. Patients who received no liver metastasis; or the number of liver metastases was ≤ 3 and the longest diameter of a single lesion was ≤ 1.5 cm; or although the longest diameter of a single lesion was \\> 1.5 cm, the imaging was stable for at least 3 weeks after local treatment control;\n8. Patients with brain metastasis at baseline should meet all the following conditions: lesions not involving the brainstem, the number of brain metastases ≤ 2 (but patients with only intracranial target lesions should be excluded), imaging stability for at least 3 weeks after local treatment control, and no application of dehydration drugs and hormones before screening,Without any symptoms of brain metastasis;\n9. Organ function meeting the following criteria at screening: a.Blood routine: neutrophil (ANC) ≥ 1.5 × 109\u002FL, platelet (PLT) ≥ 100 × 109\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL; b.Liver function: total bilirubin (TBIL) ≤ 1.0 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.0 × ULN; if liver metastases, AST and ALT ≤ 3 × ULN; serum albumin ≥ 30 g\u002FL; c.Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 40 mL\u002Fmin; d.Coagulation function: Prothrombin time - international normalized ratio (PT-INR) \\\u003C 1.5;\n10. Has fully understood and voluntarily signed a written informed consent form for this study and is able to comply with the requirements and restrictions listed in the informed consent form;\n11. Female subjects of childbearing potential and male subjects with partners of childbearing potential agree to use reliable contraceptive measures during the study and within 6 months after the infusion of study drug.\n\nExclusion Criteria:\n\n1. Pathological diagnosis of compound small cell lung cancer;\n2. Patients with meningeal metastasis, spinal cord tumor invasion, spinal cord compression syndrome;\n3. Superior vena cava syndrome with symptoms or significantly aggravated imaging, which may require radiotherapy\u002Fsurgery\u002Fendoscopic therapy\u002Fintervention and other non-medical treatment; the presence of large amount of pleural effusion, ascites and\u002For pericardial effusion with local treatment and unstable control;\n4. Active infection (including tuberculosis infection) requiring systemic anti-bacterial, antifungal, antiviral and other treatments during screening;\n5. Recurrent symptomatic poorly controlled chronic obstructive pulmonary disease, extensive interstitial lung disease (including interstitial pneumonia, pulmonary interstitial fibrosis, etc.) at screening,\n6. Extensive radiation pneumonitis, pulmonary embolism or active massive hemoptysis; Patients with severe gastrointestinal diseases or gastrointestinal disorders (such as gastrointestinal bleeding, gastrointestinal obstruction, unhealed peptic ulcer, immune enteritis, ulcerative colitis, Crohn's disease, ischemic necrotizing enteritis, diarrhea \\> grade 1, other gastrointestinal diseases that may affect the tolerance of chemotherapy) at screening;\n7. Patients with the following cardiovascular and cerebrovascular diseases or history:\n\n   1. patients with unstable hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg) or a history of hypertensive crisis or hypertensive encephalopathy;\n   2. patients with unstable severe arrhythmia;\n   3. patients with the following cardiovascular and cerebrovascular diseases within 6 months: myocardial infarction, unstable angina, coronary revascularization\u002Fangioplasty, coronary artery bypass grafting, coronary artery stenting, New York Heart Association (NYHA) class ≥ 2 cardiac insufficiency, severe unstable arrhythmia, deep vein thrombosis, pulmonary embolism history, active cerebral infarction, active cerebral hemorrhage;\n8. Patients with any of the following conditions:\n\n   1. positive hepatitis B virus surface antigen (HBsAg) test,And peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) detection ≥ 1000 IU\u002FmL;\n   2. hepatitis C virus antibody (HCV-Ab) positive, and hepatitis C virus ribonucleic acid (HCV-RNA) detection ≥ 100 IU\u002FmL;\n   3. human immunodeficiency virus antibody (HIV-Ab) detection positive;\n9. Other malignancies within 5 years before screening (except cured stage IB or lower cervical cancer, non-invasive basal cell, scale-cell skin cancer or resectable carcinoma in situ);\n10. Patients with primary diseases of other important organs (such as nervous system, cardiovascular and cerebrovascular system, urinary system, digestive system, respiratory system or metabolic endocrine system diseases) and the researchers believe that it is not suitable for participants, or for other reasons the researchers believe that it is not suitable for participants;\n11. Previous treatment with irinotecan or irinotecan modified, topotecan or other topoisomerase I inhibitors;\n12. Known hypersensitivity to irinotecan hydrochloride liposomes or its excipients, structurally similar compounds (such as camptothecin compounds), other liposomal drugs, and topotecan;\n13. Those who have been vaccinated with live vaccine or live attenuated vaccine before screening;\n14. Patients who have received systemic anti-tumor therapy in 4 weeks before randomization;\n15. Patients who have applied other clinical trial drugs\u002Fdevices before randomization;\n16. Patients who have used strong inducers or strong inhibitors of CYP3A4 and strong inhibitors of UGT1A1 before randomization;\n17. Adverse reactions caused by previous anti-tumor treatment are not recovered to grade 1 or lower (except alopecia and peripheral neuropathy);\n18. History of drug abuse, drug abuse and\u002For alcoholism;\n19. Pregnant or lactating women;\n20. Other conditions (including but not limited to unstable nervous system diseases and mental disorders) that are considered unsuitable for inclusion in this trial by the investigator.",true,{"count":79,"type":20},686,[56],"This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung Cancer (SCLC)",[27],"2024-03-12",{"date":85,"type":37},"2024-03-15",{"date":87,"type":37},"2024-03-03",{"date":89,"type":20},"2028-10",{"name":67,"class":68}]