[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-cell-carcinoma-of-lung\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-cell-carcinoma-of-lung":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,49,72,102,125,145,179],{"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":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100627900","phase-1-ava6103-in-subjects-with-locally-advanced-or-metastatic-selected-solid-tumors-100627900",false,"NCT07454642","AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","A Phase 1, Open Label, Dose-Escalation and Expansion Study to Evaluate Safety, Pharmacokinetics and Initial Therapeutic Activity of AVA6103, a Novel FAP-activated Exatecan Administered Intravenously in Subjects With Locally Advanced or Metastatic Selected Solid Tumors","FOCUS-01","Inclusion Criteria:\n\n1. The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF).\n2. Male or female subjects, ≥18 years of age.\n3. Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and\u002For metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments\n\n   1. Cervical\u002Fvulvar cancer\n   2. SCLC\n   3. Gastric\u002FGEJ cancer\n   4. PDAC\n   5. CRC\n   6. HR+ breast cancer\n4. Has a life expectancy of ≥3 months, in the opinion of the investigator.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropathy, which can be up to CTCAE Grade 2).\n7. Has adequate hematological function (applies only to subjects not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose):\n\n   1. Absolute neutrophil count of ≥1.5 × 109 cells\u002FL. Subjects with documented benign ethnic neutropenia may be enrolled with an absolute neutrophil count of ≥1.0 × 109 cells\u002FL\n   2. Hemoglobin ≥9.0 g\u002FdL.\n   3. Platelet count of ≥100,000\u002FµL.\n   4. International normalized ratio and activated partial thromboplastin time ≤1.5 times the ULN, except for subjects on direct acting anticoagulation.\n8. Has adequate liver function:\n\n   1. Total bilirubin 1.5 × ULN (except for subjects with documented Gilbert's Syndrome or liver metastases who must have a total bilirubin \\\u003C3 × ULN).\n   2. AST and ALT ≤2.5 × ULN (in subjects with liver metastases, \\\u003C5 × ULN is allowed).\n9. Has adequate renal function as defined by creatinine clearance ≥ 60 mL\u002Fmin by the Cockcroft-Gault equation.\n10. Women of childbearing potential and women who have ≤2 years amenorrhea after start of menopause, must have a negative serum or urine pregnancy test within 7 days prior to Cycle 1 Day 1.\n11. Contraception requirements:\n\n    1. Female subjects of childbearing potential must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method (Pearl Index failure rate \\\u003C 1% per year) during the treatment period and for at least 6 months after the last dose of study drug.\n    2. Male subjects with female partners of childbearing potential must agree to using 2 acceptable methods of contraception (Pearl Index failure rate \\\u003C1% per year), including a barrier method (with or without spermicide) during the treatment period and for at least 6 months after the last dose of study drug.\n    3. Male subjects must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug.\n12. The subject is willing and able to comply with the protocol, including any PK blood sampling and tumor biopsy requirements and agrees to return to clinic for follow-up visits and examinations.\n\n    1. For subjects in Phase 1a or 1b, on treatment tumor biopsy is optional. -\n\nExclusion Criteria:\n\n1. Has active or suspected central nervous system (CNS) metastases as determined by the Investigator. Subjects may still be eligible if CNS metastases are definitively treated with radiotherapy, the subject is asymptomatic, not requiring corticosteroids (prednisone or equivalent must be 10 mg\u002Fday or less), and have had repeat imaging no less than 4 weeks after completing radiotherapy to document stability.\n2. Subjects who have any history of an active (requiring treatment) other malignancy (except any in-situ carcinoma, non-melanoma skin carcinoma and early prostate cancer with a normal prostate-specific antigen) within 2 years of study entry.\n3. Has a significant, uncontrolled, concomitant disease that could affect compliance with the protocol.\n4. History or evidence of any other clinically unstable\u002Funcontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.\n5. History of known infection is defined as:\n\n   1. HIV infection defined as: An AIDS-defining infection within 12 months of planned study Day 1. Subjects on anti-retroviral treatment who are not established on anti-retroviral treatment for ≥4 weeks and who have a viral load \\>400 copies\u002FmL prior to study Day 1.\n   2. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as: a positive hepatitis B surface antigen (HBsAG) test at screening. Subjects with a past or resolved HBV infection (defined as having a negative HBsAG test and a positive antibody to hepatitis B core antigen antibody test) are eligible. Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n   3. Chronic HBV (HBsAg positive, undetectable or low HBV DNA and normal ALT).\n   4. Subjects with active disease who are not on\u002Fhave not initiated anti-retroviral treatment prior to study Day 1.\n   5. Subjects with untreated HCV infection or have not completed treatment for HCV infection.\n   6. Subjects with treated HCV infection but with an HCV viral load above the level of quantification.\n   7. Has a severe infection (requiring IV antibiotic treatment) within 21 days prior to Cycle 1, Day 1 including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.\n6. Has any other clinically significant active disease, metabolic dysfunction, physical examination finding, altered mental status, clinical laboratory finding, or reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug in the opinion of the investigator.\n7. Has had major surgery within 21 days prior to Cycle 1, Day 1 (excluding biopsies) or anticipates the need for major surgery during study treatment.\n8. Is a pregnant or breastfeeding woman.\n9. Has a known hypersensitivity to any of the components of AVA6103 or any excipient of the product or to other topoisomerase 1 (TOP1) inhibitors.\n10. Has received prior investigational therapy (defined as a treatment for which there is no Regulatory Authority-approved indication) within 5 half-lives or 28 days (whichever is shorter) of Cycle 1 Day 1.\n11. Has received any approved anticancer therapy, including chemotherapy or hormonal therapy, within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1, with the following exception:\n\n    1. Is planned for on-study treatment or has received within 14 days (or 5 half-lives, whichever is shorter) prior to Cycle 1 Day 1.\n    2. Subjects who have received a monoclonal antibody.\n12. Is currently taking St John's Wort, any drugs that are a strong inhibitor or inducer of cytochrome P450 (CYP)3A4, CYP1A2, CYP2D6, or P-glycoprotein (P-gp) such as ketoconazole, Nifedipine, erythromycin and fentanyl.\n13. Drugs which are strong inhibitors of multidrug resistance protein (MRP)2, MRP3 or MRP4.\n14. Is planned for on study treatment with any drugs that are sensitive CYP3A4 or organic anion transporting polypeptide (OATP)1B3 substrates, and\u002For where these drugs will be in the systemic circulation at the start of Cycle 1, Day 1. For this protocol, it means that the drug must not be used within 5 half-lives (or 5 days, whichever is longer) prior to AVA6103 Cycle 1 Day 1 and during study treatment.\n15. Has received granulocyte-colony stimulating factor (G-CSF), or red blood cell or platelet transfusion within 14 days prior to Cycle 1 Day 1.\n16. Has received radiotherapy within 28 days prior to Cycle 1 Day 1, except for limited field palliative radiotherapy, which requires at least a 7-day washout period.\n17. Has received live attenuated vaccine within 30 days prior to Cycle 1 Day 1. Note: If a COVID-19 vaccine is administered it should be done \\>96 hours prior to AVA6103 administration. For the dose escalation phase, it should be administered after completion of the DLT period.\n18. QT interval corrected through use of Fridericia's formula (QTcF) \\> 470 ms demonstrated by at least two single ECGs ≥ 30 minutes apart.","ALL","18 Years",{"count":20,"type":21},174,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.",[27,28,29,30,31,32,33,34,35],"Vulvar Adenocarcinoma","PDAC - Pancreatic Ductal Adenocarcinoma","Gastric Adenocarcinoma","GEJ Adenocarcinoma","Cervical Adenocarcinoma","Cervical Adenosquamous Carcinoma","Small Cell Carcinoma of Lung","Colorectal Cancer","Hormone Receptor Positive Breast Carcinoma","RECRUITING","2026-05-29",{"date":39,"type":40},"2026-06-02","ACTUAL",{"date":42,"type":40},"2026-03-31",{"date":44,"type":21},"2030-06",{"name":46,"class":47},"Avacta Life Sciences Ltd","INDUSTRY",3,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100635296","phase-1-a-clinical-study-for-the-safety-and-efficacy-of-bl0020-injection-in-combination-with-toripalimab-injection-in-patients-with-recurrent-extensive-stage-small-cell-lung-cancer-100635296","NCT07550842","A Clinical Study for the Safety and Efficacy of BL0020 Injection in Combination With Toripalimab Injection in Patients With Recurrent Extensive-Stage Small Cell Lung Cancer","An Open, Multi-center Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of BL0020 Injection in Combination With Toripalimab Injection in Patients With Recurrent Extensive-Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Volunteer to participate in the study, be able to understand the requirements of a clinical study, and willingness to sign a written informed consent form.\n2. Aged ≥ 18 years, male or female.\n3. Patients with histologically or cytologically confirmed ES-SCLC (per the American Veterans Administration Lung Study Group \\[VALG\\] staging system) who have relapsed or progressed following first-line platinum-based systemic treatment regimen.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.\n5. Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Chemotherapy-free interval (CTFI: time from the last dose of first-line platinum-based chemotherapy to disease progression) \\\u003C 30 days, regardless of maintenance treatment with immune checkpoint inhibitors.\n2. Histologically or cytologically confirmed combined SCLC and transformed SCLC.\n3. Patients with central nervous system (CNS) metastases or carcinoma meningitis. Note: Patients with asymptomatic CNS metastases may participate in this study if they meet all the following criteria:\n\n1)Patients with treated CNS metastases may participate in this study if the patient has completed radiotherapy or surgery for CNS metastases ≥ 4 weeks prior to study entry, and if the patient is neurologically stable ≥ 4 weeks after radiotherapy or surgery treatment (no new neurologic deficits from brain metastasis on screening clinical examination, no new findings on CNS imaging, and high doses of corticosteroids \\[\\> 10 mg prednisone daily or equivalent\\] were not required within 4 weeks prior to screening).\n\n2)Only supratentorial and cerebellar metastases allowed (i.e., no metastases to midbrain, pons, medulla or spinal cord).\n\n4.Previous or current autoimmune disease, including but not limited to Crohn's disease, ulcerative colitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the following allowed exceptions:\n\n1. Patients with a history of autoimmune-related hypothyroidism on thyroid replacement hormone therapy.\n2. Patients with controlled Type I diabetes mellitus on an insulin regimen.\n3. Patients with vitiligo. 5.Patients with Gilbert's syndrome disease. 6.Patients who have a history of another primary malignancy (with the exception of patients with cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix). A patient who has had no evidence of disease from another primary cancer for 3 or more years is allowed to participate in the study.\n\n7.Poorly controlled hypertension (defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy.\n\n8.Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive during screening.\n\n9.Active hepatitis C or chronic hepatitis B at screening (\"active hepatitis\" defined as HCV RNA ≥ ULN at the local clinical site for hepatitis C, or HBV DNA ≥ ULN at the local clinical site for hepatitis B). Note: Antiviral therapy may be administered during the study to prevent viral reactivation if necessary.\n\n10.Patients who have not sufficient baseline organ function. 11.Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine) within 4 weeks before enrollment or scheduled to receive during the study.\n\n12.Known allergy to Toripalimab, BL0020, or any of their excipients. 13.Pregnant or lactating women. 14.Patients who are assessed disqualified to join clinical studies by investigator due to any causes.",{"count":57,"type":21},33,[24],"Lung cancer remains the leading cause of cancer deaths worldwide; in 2022, there were approximately 2.48 million new cases and 1.8 million deaths from lung cancer globally. Globally, lung cancer is the leading cause of cancer-related deaths in men and the second leading cause in women after breast cancer. Among them, small cell lung cancer (SCLC) accounts for approximately 14% of all newly diagnosed lung cancers. Small cell lung cancer (SCLC) is a highly heterogeneous and aggressive disease with poor survival outcomes.\n\nA 2-stage system dividing patients into limited and extensive disease was developed in 1973 by the United States (US) Veteran's Administration Lung Cancer Study Group (VALG), which has been used to this day. Patients with limited-stage SCLC can be treated with chemotherapy and radiation with the potential for long-term survival. However, the majority (approximately 70%) of patients with SCLC are diagnosed with extensive-stage SCLC (ES-SCLC), which has poor survival prospects. Chest pain, dyspnea, and cough are among the most frequent disease-related symptoms experienced by patients with SCLC. Immune checkpoint inhibitors in combination with platinum-based systemic therapy can palliate symptoms and prolong survival for patients with ES-SCLC. However, long-term survival is rare.\n\nThe current standard first-line treatment for patients with ES-SCLC is immune checkpoint inhibitors in combination with platinum-based systemic therapy. Despite the impressive high objective response rates (approximately 60%-80%) observed with first-line treatment regimens, the median overall survival (OS) of patients rarely exceeds 16 months, and the median progression-free survival (PFS) is also limited to around 5 months. Second-line and subsequent therapeutic options are limited. The main treatment drugs include Topotecan, Lurbinectedin, Tarlatamab, etc., with objective response rates rarely exceeding 40%. Therefore, there is a significant need for improved novel treatment options for patients with ES-SCLC.\n\nThis is a multi-center, open-label study. The study is designed to evaluate the safety, tolerability, and preliminary efficacy of Toripalimab in combination with BL0020 in patients with ES-SCLC who have relapsed or progressed following first-line platinum-based systemic treatment regimen.",[33],"NOT_YET_RECRUITING","2026-04-20",{"date":64,"type":40},"2026-04-24",{"date":66,"type":21},"2026-06-16",{"date":68,"type":21},"2028-08-18",{"name":70,"class":47},"Shanghai Best-Link Bioscience, LLC",8,{"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":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100633627","cardiopulmonary-exercise-testing-in-lung-cancer-patients-before-and-during-oncological-treatment-100633627","NCT07529145","Cardiopulmonary Exercise Testing in Lung Cancer Patients Before and During Oncological Treatment","Assessment of Respiratory Parameters and Physical Performance in Patients With Lung Cancer Qualified for Oncological Treatment Before and During Therapy, With Special Consideration of Cardiovascular Risk: A Cardiopulmonary Exercise Testing Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed lung cancer (any stage)\n* Qualified for standard oncological management (surgery and\u002For systemic therapy)\n* WHO\u002FECOG performance status 0-2\n* Ability to perform cardiopulmonary exercise testing (CPET)\n* Written informed consent\n\nExclusion Criteria:\n\n* Unstable ischemic heart disease\n* Symptomatic cardiac arrhythmias\n* Myocarditis or pericarditis\n* Decompensated heart failure\n* Active deep vein thrombosis\n* Suspected aortic dissection or severe aortic stenosis\n* Poorly controlled asthma\n* Resting oxygen saturation ≤ 85% on room air\n* Clinically relevant treatment-related adverse events above mild intensity (as applicable)\n* Any medical condition that, in the investigator's opinion, precludes safe participation in CPET\n* Withdrawal of informed consent",{"count":80,"type":21},90,"OBSERVATIONAL","Patients with lung cancer often have reduced physical fitness and coexisting health problems, which may limit their ability to tolerate oncological treatment. Standard resting lung and heart tests do not always reflect real-life physical capacity during everyday activities or physical effort.\n\nThis observational study aims to assess cardiorespiratory fitness in patients with lung cancer before and during standard oncological treatment using cardiopulmonary exercise testing (CPET). CPET is a safe, supervised exercise test that provides objective information on how the heart, lungs, and muscles respond to physical effort.\n\nParticipants with WHO\u002FECOG performance status 0-2 will undergo CPET before treatment initiation and again after the early phase of therapy or surgery. The results may help identify patients with reduced physiological reserve and support individualized monitoring during routine clinical care.",[84,33],"Non-Small Cell Carcinoma of Lung",[86,87,88,89,90],"lung cancer treatment","cpet","V02peak","ventilatory efficiency","cardiopulmonary exercise testing","2026-04-07",{"date":93,"type":40},"2026-04-14",{"date":95,"type":40},"2026-01-01",{"date":97,"type":21},"2027-09-01",{"name":99,"class":100},"Medical University of Bialystok","OTHER",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":101},"100579930","phase-2-clinical-trial-for-safety-and-effectiveness-evaluation-of-tarlatamab-amg757-with-etoposide-carboplatin-and-atezolizumab-in-transformed-small-cell-lung-cancer-patients-from-adenocarcinoma-after-egfr-tki-treatment-100579930","NCT06830694","Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From Adenocarcinoma After EGFR TKI Treatment","Clinical Trial for Safety and Effectiveness Evaluation of Tarlatamab (AMG757) With Etoposide, Carboplatin and Atezolizumab in Transformed Small Cell Lung Cancer Patients From Adenocarcinoma After EGFR TKI Treatment: Phase II Multicenter Clinical Trial","Inclusion Criteria:\n\n1. Histologically confirmed SCLC and no prior systemic treatment for SCLC\n2. Patient initially diagnosed with activating EGFR mutation (L858R, Del 19) and treated with any kind of EGFR TKI.\n3. Confirmed SCLC transformation right after EGFR TKI treatment failure.\n4. Age ≥19 years\n5. ECOG performance status of 0 to 1\n6. Had at least one measurable lesion.\n7. Adequate organ function\n\n   * Absolute neutrophil count ≥ 1.5 x 109\u002FL\n   * Platelet count ≥ 100 x 109\u002FL\n   * Hemoglobin ≥ 9 g\u002FdL\n   * Estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation \\> 30 mL\u002Fmin\u002F1.73 m2\n   * Aspartate aminotransferase and alanine aminotransferase ≤ 3 x upper limit of normal (ULN) (or ≤ 5 x ULN for subjects with liver involvement)\n   * Total bilirubin ≤ 1.5 x ULN (or ≤ 2 x ULN for subjects with liver metastases)\n   * Prothrombin time (PT)\u002Finternational normalized ratio and partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 x institutional ULN Note: Subjects on stable anticoagulation therapy are allowed.\n8. Pulmonary function: No clinically significant pleural effusion at the timepoint of screening. Pleural effusion with no significant symptom is allowed for enrollment.\n9. Cardiac function: Cardiac ejection fraction ≥ 50%\n10. Female subjects must either be of non-reproductive potential\n11. Female subject with reproductive potential can be enrolled with agreement to following guidance.\n\n    * subject uses contraception during treatment and through 60 days after receiving last dose of tarlatamab or for 6 months after last dose of carboplatin and\u002For etoposide and 5 months after last dose of atezolizumab.\n12. Subject is willing and able to comply with the protocol\n13. Signed written informed consent\n\nExclusion Criteria:\n\n1. Treated with additional chemotherapy after confirmed with transformed SCLC.\n2. Previously exposed to the immune checkpoint inhibitor treatment.\n3. Untreated symptomatic brain metastases or leptomeningeal disease.\n\n   * Asymptomatic brain metastases can be enrolled per investigator decision\n4. Uncontrolled systemic illness including uncontrolled hypertension, active bleeding, or active infection.\n5. Past medical history of interstitial lung disease, drug induced interstitial lung disease, radiation pneumonitis which required steroid treatment, active non- infectious pneumonitis\n6. Active or prior documented autoimmune or inflammatory disorders\n7. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\> class II) within 6 months prior to first dose of study treatment\n8. History of solid organ transplant.\n9. Major surgical procedures within 28 days prior to first dose of study treatment.\n10. History of allergic reactions or acute hypersensitivity reactions to antibody therapies, platinum chemotherapy, or etoposide.\n11. Disagree to the guidance of contraception during the study.","19 Years",{"count":111,"type":21},50,[113],"PHASE2","The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma (ADC) with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase inhibitor (TKI). After a certain period of treatment with EGFR TKI, acquired resistance emerges most frequently with a secondary mutation, p.T790M (36-50%), followed by MET amplification (10-19%). Interestingly, up to 3-5% of patients experience histological transformation into small cell lung cancer (SCLC).\n\nAs an underlying mechanism, ADC with a predisposed clonally inactivated Rb and p53 mutation and APOBEC mutation signature is known to be associated with SCLC transformation. The transformed SCLC harbors similar morphological and immunohistochemical (IHC) characteristics as those observed in de novo SCLC, including high expression of chromogranin and synaptophysin. However, little is known about the clinical outcomes of transformed SCLC, with limited studies arguing that their outcomes are similar to those of de novo SCLC, where the median overall survival is approximately 9 to 10 months after the transformation.\n\nAs the first line treatment of SCLC, atezolizumab or durvalumab with four cycles of conventional chemotherapy followed by maintenance therapy demonstrated prolonged overall survival (OS) and placed as the standard treatment option. However, median progression-free survival (PFS) of both study was only 5.2 months and 5.1 months, despite the objective response rate showing 60.2% and 79%. This finding suggest further development of maintenance treatment strategy to prolonged longer duration of response to the treatment.\n\nIn addition to the conventional treatment, Tarlatamab (AMG757), bispecific t-cell engager (BiTE), designed to engage DLL3 on SCLC and CD3 on T-cell has been tested in SCLC. DLL3 is expressed in more than 80% of patients with SCLC, regardless of disease stage and researched for the potential target protein for the antibody based treatment in SCLC. By targeting DLL3 using Tarlatamab, engagement of tumor antigen and CD3 lead to cytotoxic synapse formation, triggering the release of proinflammatory cytokines, perforin, and granzymes from activated T-cells, potentially resulting apoptosis. The first clinical outcome of Tarlatamab was reported from the DeLLphi-300 study, phase 1 dose exploration study, showing confirmed partial response in 23% of the heavily treated SCLC and 37% of the patients showed decrease in tumor burden. Median duration of response was 13.0 months (95% confidential interval CI: 6.2 - 14.9 months), median PFS of 3.7 months and median OS was 13.2 months. In the treatment naïve SCLC, DeLLphi-303 study, phase 1b study combining tarlatamab + PD-L1 inhibitor + carboplatin and etoposide, is ongoing to evaluate the clinical efficacy in the front line setting which include only histologically confirmed extensive disease SCLC population (NCT05361395).\n\nBased on previous clinical and pre-clinical outcomes, showing similar disease characteristics between transformed SCLC from the adenocarcinoma who treated with EGFR TKI with de novo SCLC, this study is designed to evaluate the clinical efficacy of tarlatamab with currently standard treatment in transformed SCLC.",[33],"2026-02-19",{"date":118,"type":40},"2026-02-23",{"date":120,"type":40},"2025-05-13",{"date":122,"type":21},"2027-06-30",{"name":124,"class":100},"Se-Hoon Lee",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":101},"100624845","phase-1-a-clinical-study-for-the-efficacy-and-safety-of-bl0020-injection-in-patients-with-small-cell-lung-cancer-transformed-from-non-small-cell-lung-cancer-following-egfr-tki-therapy-100624845","NCT07414927","A Clinical Study for the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy","An Open-Label, Single-Arm Phase I\u002FII Clinical Study to Evaluate the Efficacy and Safety of BL0020 Injection in Patients With Small Cell Lung Cancer Transformed From Non-Small Cell Lung Cancer Following EGFR TKI Therapy","Inclusion Criteria:\n\n1. Volunteer to participate in the study, be able to understand the requirements of a clinical study, and willingness to sign a written informed consent form.\n2. Aged ≥ 18 years, male or female.\n3. Patients with initial diagnosis of EGFR-mutated NSCLC and histologically or cytologically confirmed transformation to SCLC following treatment with EGFR tyrosine kinase inhibitor.\n4. After transformation to SCLC, the patient's prior treatment history must meet one of the following criteria:\n\n   * Progression after only receiving platinum-based treatment regimens.\n   * No prior systemic therapy for SCLC.\n5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening.\n6. Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n1. Patients with symptomatic brain metastases or carcinoma meningitis. Note:\n\n   * Patients with treated brain metastases may participate in this study if the patient has completed radiotherapy or surgery for brain metastases ≥ 4 weeks prior to study entry, and neurologically stable ≥ 4 weeks after radiotherapy or surgery treatment \\[i.e., no new findings on brain imaging and no new neurologic deficits from brain metastasis on screening examination, and high doses of corticosteroids (\\> 10 mg prednisone daily or equivalent) were not required within 4 weeks prior to enrollment\\].\n   * Patients with brainstem metastases or spinal cord compression (detected by radiographic imaging, even if they did not have symptoms) were not eligible.\n2. Patients who have a history of another primary malignancy (with the exception of patients with cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of uterine cervix). A patient who has had no evidence of disease from another primary cancer for 3 or more years is allowed to participate in the study.\n3. Patients with tumors that had invaded important blood vessels as shown in the screening imaging and that the investigators assessed were highly likely to cause fatal bleeding during the study.\n4. Patients whose pericardial effusion, pleural effusion or ascites remain uncontrollable after intervention.\n5. Patients with Gilbert's syndrome disease.\n6. Patients who have a known diagnosis of Human Immunodeficiency Virus (HIV) infection or HIV antibody test positive during screening.\n7. Patients with active hepatitis C or chronic hepatitis B at screening (\"active hepatitis\" defined as HCV RNA level ≥ 200 IU\u002FmL for hepatitis C or HBV DNA level ≥ 2000 IU\u002FmL for hepatitis B at screening). In addition, eligible hepatitis B or hepatitis C patients must agree to antiviral treatment according to the treatment guidelines.\n8. Patients who have not sufficient baseline organ function.\n9. Those who are known to be allergic to the active ingredient or excipients of the investigational product BL0020 Injection, or who have a predisposition to allergy.\n10. Patients who are taking anticoagulant therapy (prophylactic use of low-dose aspirin \\[≤ 100 mg\u002Fday\\] or low molecular weight heparin is allowed).\n11. Those who have received live or attenuated vaccines (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, typhoid vaccine, etc.) within 4 weeks before enrollment or scheduled to receive during the study.\n12. Pregnant or lactating women.\n13. Patients who are assessed disqualified to join clinical studies by investigator due to any causes.",{"count":133,"type":21},48,[24,113],"The primary treatment option for non-small cell lung cancer (NSCLC) adenocarcinoma with activating epidermal growth factor receptor (EGFR) mutation is EGFR tyrosine kinase inhibitor (TKI). After a certain period of treatment with EGFR TKI, acquired resistance emerges most frequently with a secondary mutation, p.T790M, followed by MET amplification. Interestingly, up to 3-14% of patients experience histological transformation into small cell lung cancer (SCLC), which has an aggressive clinical course and a poor prognosis.\n\nThe transformed SCLC retains the original EGFR mutation but significantly down regulates EGFR protein expression, eliminating its dependence on EGFR signaling while simultaneously acquiring a neuroendocrine phenotype. In nearly all cases, bi-allelic inactivation of both TP53 and RB1 is observed. However, little is known about the clinical outcomes of transformed SCLC, with limited studies arguing that their outcomes are similar to those of de novo SCLC, where the median overall survival is approximately 9 to 10 months after the transformation.\n\nAt present, there is no standard treatment regimen for patients with SCLC transformed from NSCLC following EGFR TKI therapy.\n\nBL0020 is a polymer-drug conjugate consisting of Topoisomerase I inhibitor SN-38 (7-ethyl-10-hydroxycamptothecin) conjugated by a peptide linker to a PEG-modified poly(ε-L-lysine) polymer. In the ongoing first-in-human study of BL0020, significant efficacy has been observed with BL0020 monotherapy in SCLC patients who have relapsed or progressed following at least first-line platinum-based systemic treatment.\n\nBased on previous clinical and preclinical outcomes that show similar disease characteristics between SCLC transformed from NSCLC following EGFR TKI therapy and de novo SCLC, this study is designed to evaluate the clinical efficacy and safety of BL0020 in patients with transformed SCLC.",[33],"2026-02-14",{"date":139,"type":40},"2026-02-17",{"date":141,"type":21},"2026-03-27",{"date":143,"type":21},"2028-02-20",{"name":70,"class":47},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":152,"sex":17,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":159,"conditions":160,"keywords":164,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100622425","lung-cancer-screening-in-population-who-had-never-smoked-100622425","NCT07383454","Lung Cancer Screening in Population Who Had Never Smoked","Lung Cancer Screening in Population Who Had Never Smoked and the Validation of Lung Cancer Risk Prediction Model","Inclusion Criteria:\n\n1. Individuals with no history of smoking.\n2. Aged 40 to 80 years.\n3. Willing to provide written informed consent and complete questionnaire assessments.\n4. After undergoing examinations, willing to provide relevant biological information, including but not limited to: blood samples, urine samples, pulmonary function test results, imaging data, and tissue specimens obtained from invasive biopsies or surgical procedures (if applicable).\n\nExclusion Criteria:\n\n1. History of lung cancer, or a diagnosis of any malignancy other than skin cancer or cervical carcinoma in situ within the past five years.\n2. Undergoing chest computed tomography (CT) scans within the past 18 months.\n3. Unexplained hemoptysis within the past one month.\n4. Unexplained weight loss exceeding 6 kilograms within the past one year.\n5. Pregnancy.",true,"40 Years","80 Years",{"count":156,"type":21},2500,[158],"NA","Study design: prospective, single arm.\n\nObjectives: survey lung cancer detection rate of low-dose computed tomography (LDCT) screening in individuals who had never smoked.\n\nParticipants will undergo questionnaires, and collecting specimens including blood, urine, and medical informations including results of pulmonary function tests, and LDCT screening upon inclusion. The participants will be followed up according to current standards of clinical practice.",[161,162,33,163],"Lung Cancer (Diagnosis)","Non-Small Cell Lung Cancer","Screening Strategy",[165,166,167,168,169],"Low dose computed tomography (LDCT)","Lung cancer in individuals who had never smoked (LCINS)","Lung cancer risk prediction model (LCRPM)","Lung cancer","Non-small cell lung cancer (NSCLC)","2026-01-26",{"date":172,"type":40},"2026-02-03",{"date":174,"type":21},"2026-02-01",{"date":176,"type":21},"2034-12",{"name":178,"class":100},"Chung Shan Medical University",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":194,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":101},"100608823","phase-1-penfluridol-for-relapsedrefractory-small-cell-cancers-100608823","NCT07206563","Penfluridol for Relapsed\u002FRefractory Small Cell Cancers","Penfluridol for Relapsed\u002FRefractory Small Cell Lung Carcinoma and Small Cell Cervical Cancer: An Open-Label, Multicenter, Single-Arm Ib\u002FII Trial","Inclusion Criteria:\n\n1. Patients aged 18 to 75 years, inclusive, regardless of gender.\n2. Histologically or cytologically confirmed small-cell carcinoma of the lung or cervix that is not curable by surgery or radiochemotherapy.\n3. Have received at least two prior systemic treatment regimens, including etoposide and platinum-based chemotherapy, and have experienced disease progression.\n4. No receipt of investigational or approved cytotoxic chemotherapy within 28 days before enrollment; no receipt of alkylating agents within 42 days before enrollment; no receipt of investigational or approved targeted therapy within 28 days or 5 half-lives before enrollment (whichever is shorter, but not less than 14 days); no radiotherapy within 14 days before enrollment.\n5. Presence of measurable disease according to RECIST 1.1 criteria; measurable lesions are defined as lesions that can be accurately measured in at least one dimension (longest diameter ≥10 mm on CT or MRI scans, and lymph nodes with short-axis diameter ≥15 mm).\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Expected survival of ≥12 weeks.\n8. Recovery of prior anticancer treatment toxicities to ≤Grade 1 (except for alopecia, pigmentation, or other toxicities deemed non-safety risks by the investigator); for irreversible toxicities that are not expected to worsen with study drug administration (e.g., hearing loss), inclusion may be considered after consultation with the medical monitor. Recovery of peripheral neuropathy to ≤Grade 2 after prior use of cisplatin or etoposide may be considered for inclusion after consultation with the medical monitor. For late toxicities caused by radiotherapy that cannot be recovered, inclusion may be considered after consultation with the medical monitor.\n9. Laboratory tests: Absolute neutrophil count ≥1.5×10⁹\u002FL; platelets ≥75×10⁹\u002FL; hemoglobin ≥90 g\u002FL; serum creatinine ≤1.5 times the upper limit of normal (ULN); urine protein \\\u003C2+ or 24-hour urine protein \\\u003C1.0 g; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN (or ≤5 times ULN in the presence of liver metastasis); total bilirubin ≤1.5 times ULN; albumin ≥28 g\u002FL; coagulation function: prothrombin time (PT) and international normalized ratio (INR) ≤1.5×ULN.\n10. Female subjects with negative urine or blood HCG (except for menopausal and hysterectomy cases); sexually active female subjects and their partners must agree to use effective contraception (e.g., combined hormonal contraception, intrauterine device, bilateral tubal ligation, vasectomy, abstinence) during the study and for 6 months after the last dose.\n11. Availability of tumor specimens (paraffin-embedded blocks or frozen tissue) from prior resection or biopsy sufficient for pharmacodynamic assays (≥3 slides for immunohistochemistry IHC) (mandatory for dose-expansion cohort patients only).\n12. Ability to understand the study and voluntary consent to participate in the trial by the patient or their legal representative, with signed informed consent.\n\nExclusion Criteria:\n\n1. Histological diagnosis of squamous cell carcinoma, adenocarcinoma, or other non-small-cell types of lung or cervical cancer.\n2. Concurrent enrollment in another clinical trial, unless it is an observational, non-interventional study or the follow-up period of an interventional study.\n3. Known hypersensitivity to any component of penfluridol or similar compounds with comparable chemical or biological properties.\n4. Prior exposure to penfluridol.\n5. Known presence of leptomeningeal metastasis, spinal cord compression, leptomeningeal disease, or active brain metastases. However, patients with asymptomatic brain metastases (no neurological deficits, seizures, or other typical symptoms and signs of central nervous system metastasis; no requirement for corticosteroids) or those who have been treated and are stable on imaging for at least 4 weeks before study treatment (with no new or enlarged brain metastases) and have discontinued systemic corticosteroids and anticonvulsant medications for at least 2 weeks may be included.\n6. Uncontrolled comorbid conditions, including but not limited to persistent or active infections or psychiatric\u002Fsocial conditions that would limit compliance with study requirements.\n7. Positive for human immunodeficiency virus (HIV) on combination antiretroviral therapy.\n8. Cardiovascular history or comorbidities: Known history of arrhythmias (including atrial fibrillation, tachycardia, or bradycardia), except for benign ventricular premature beats; history of CHF, MI, or stroke within the past 3 months.\n9. History of seizure within the past 3 months.\n10. Gastrointestinal dysfunction or disease that may significantly alter the absorption of penfluridol (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n11. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.\n12. Uncontrolled severe medical conditions that, in the opinion of the investigator, would affect the patient's ability to receive the study treatment, such as severe internal medicine conditions, including hepatic or renal insufficiency, severe cardiovascular disease, cerebrovascular disease, uncontrolled diabetes, or uncontrolled infections.\n13. Pregnant or breastfeeding women; sexually active female subjects unwilling to use contraception.\n14. Presence of symptomatic or unstable pleural effusion, ascites, or pericardial effusion requiring repeated drainage.\n15. Patients deemed unsuitable for the study by the investigator.","75 Years",{"count":57,"type":21},[24,113],"Penfluridol for Relapsed\u002FRefractory Small-Cell Carcinoma of the Lung or Cervix: A Multicenter, Open-Label, Single-Arm Phase Ib\u002FII Trial This study evaluates the safety and anti-tumor activity of oral penfluridol, a first-generation antipsychotic that pre-clinically inhibits small-cell carcinoma (SCC) growth via DRD2 blockade, metabolic reprogramming and apoptosis induction. After ≥2 prior systemic regimens, 33 adult patients (18-75 y) with measurable, metastatic or recurrent lung or cervical SCC will be enrolled across five Chinese centers. A 3+3 dose-escalation (Ib) will establish the recommended Phase II dose (RP2D); an expansion cohort (II) will examine objective response rate (ORR, RECIST 1.1). Secondary end-points include duration of response, progression-free survival, overall survival, safety and exploratory biomarkers. Key inclusion: ECOG 0-1, adequate organ function, no active brain metastases. Penfluridol is administered once weekly, dose-escalated from 20 mg to RP2D, continued until progression or intolerance. Patients receive free study drug, PET imaging and laboratory monitoring.",[191,33,192,193],"Small Cell Carcinoma","Small Cell Lung Cancer ( SCLC )","Small Cell Cervical Carcinoma",[195,196,197,198,199],"Small cell cervical carcinoma","small cell lung carcinoma","Relapsed\u002Frefractory","Phase Ib\u002FII","DRD2 targeting","2025-09-25",{"date":202,"type":40},"2025-10-03",{"date":204,"type":21},"2025-10-01",{"date":206,"type":21},"2028-10-01",{"name":208,"class":100},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology"]