[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"squamous-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:squamous-non-small-cell-lung-cancer":86},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,51,74,96,125,154],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100605991","phase-1-a-study-to-investigate-alep03-as-monotherapy-in-adult-patients-with-selected-advanced-or-metastatic-cldn1-solid-tumors-100605991",false,"NCT07169734","A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","A Phase I\u002FII, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors","Inclusion Criteria:\n\n* Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma.\n* Have documented radiological disease progression at study entry.\n* Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.\n\nPhase I Dose Escalation:\n\n\\- Received and being refractory\u002Fintolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.\n\nPhase I RDE and Phase II:\n\n* Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.\n* Patients with actionable oncogenic drivers: received feasible targeted therapy.\n\nApplicable for Phase I Dose Escalation, Phase I RDE and Phase II:\n\n* Measurable disease per RECIST 1.1, as determined by the site.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.\n* Demonstrate adequate bone marrow and organ function as per the protocol.\n\nExclusion Criteria:\n\n* SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.\n* Has received antineoplastic therapies prior to study intervention within specified time frame.\n* Has rapidly progressing disease.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has a history of (non-infectious) interstitial lung disease\u002Fpneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and\u002For immunosuppressive therapies.\n* Has clinically significant gastrointestinal bleeding.\n* Has an active infection requiring systemic treatment.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.",[27,28,29,30,31],"Cervical Squamous Cell Carcinoma","Squamous Non-small-cell Lung Cancer","Colorectal Cancer","Intrahepatic Cholangiocarcinoma","Urothelial Carcinoma",[33,34,35,36,37],"Claudin-1 Targeted Antibody-Drug Conjugate","Monotherapy","First-in-Human","Recommended Phase 2 dose","Recommended dose for expansion","RECRUITING","2026-07-01",{"date":41,"type":42},"2026-07-02","ACTUAL",{"date":44,"type":42},"2025-08-26",{"date":46,"type":20},"2029-10-04",{"name":48,"class":49},"Alentis Therapeutics AG","INDUSTRY",41,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":50},"100573538","phase-1-a-study-to-investigate-alep02-as-monotherapy-in-adult-patients-with-selected-cldn1-solid-tumors-100573538","NCT06747585","A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors","A Phase I\u002FII, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+Squamous Solid Tumors","Inclusion Criteria:\n\n* Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC.\n* Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.\n* Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.\n* Have provided tissue for CLDN1 analysis in a central laboratory.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.\n* Demonstrate adequate bone marrow and organ function.\n* Patients must have recovered from all toxicities led by prior treatment.\n* Have measurable disease based on RECIST 1.1 as determined by the site.\n\nExclusion Criteria:\n\n* Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma.\n* Has received antineoplastic therapies prior to study intervention within specified time frame.\n* Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).\n* Patients with uncontrolled diabetes.\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate.\n* Concomitant use of drugs that are known to prolong or shorten QT and\u002For have known risk of Torsades de Pointes.",{"count":59,"type":20},170,[23,24],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P02 monotherapy in adult patients with selected squamous solid tumors.",[28,63,27,64],"Head and Neck Squamous Cell Carcinoma","Esophageal Squamous Cell Carcinoma",[33,34,35,36,37],"2026-06-26",{"date":68,"type":42},"2026-06-29",{"date":70,"type":42},"2024-12-16",{"date":72,"type":20},"2028-08-15",{"name":48,"class":49},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100609968","phase-2-a-study-of-intismeran-autogene-v940placebo--pembrolizumab-and-chemotherapy-in-metastatic-squamous-non-small-cell-lung-cancer-v940-013-100609968","NCT07221474","A Study of Intismeran Autogene (V940)\u002FPlacebo + Pembrolizumab and Chemotherapy in Metastatic Squamous Non-Small Cell Lung Cancer (V940-013)","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of V940 in Combination With Pembrolizumab and Chemotherapy as First-Line Treatment for Participants With Metastatic Squamous NSCLC (INTerpath-013)","INTerpath-13","Inclusion Criteria:\n\nInclusion Criteria include, but are not limited to:\n\n* Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.\n* Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator\u002Fradiology\n* Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated\n* Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization\n* Has a life expectancy of at least 3 months\n* Has adequate organ function\n\nExclusion Criteria:\n\nExclusion Criteria include, but are not limited to:\n\n* Is HIV-infected with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)\n* Has received prior systemic anticancer therapy for their metastatic NSCLC\n* Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Has received radiation therapy to the lung that is \\>30 gray within 6 months of start of study intervention\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis\n* Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and\u002For any of their excipients\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy\n* Has a history of stem cell\u002Fsolid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications",{"count":19,"type":20},[24],"Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer.\n\nThe goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.",[86],"Squamous Non-small Cell Lung Cancer","2026-06-24",{"date":66,"type":42},{"date":90,"type":42},"2025-12-12",{"date":92,"type":20},"2031-05-06",{"name":94,"class":49},"Merck Sharp & Dohme LLC",53,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":113,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100448747","phase-1-a-phase-iiia-study-of-azd8205-given-alone-or-combined-in-participants-with-advancedmetastatic-solid-malignancies-100448747","NCT05123482","A Phase I\u002FIIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced\u002FMetastatic Solid Malignancies","A Phase I\u002FIIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)","Key Inclusion Criteria:\n\n* Age ≥ 18 years\n* Relapsed\u002Fmetastatic solid tumors treated with prior adequate standard of care therapy for tumor type and stage of disease or where in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and\u002For tolerability to prior therapy.\n* Measurable disease per RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Life expectancy ≥ 12 weeks\n* Adequate bone marrow, hepatic, and renal function as defined in the protocol\n\nAdditional Inclusion Criteria For Sub-Study 1 Part A:\n\n• Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, ovarian cancer, BTC or endometrial cancer\n\nAdditional Inclusion Criteria For Sub-Study 1 Part B:\n\n* Histologically or cytologically confirmed metastatic or locally advanced and recurrent disease for the respective cohort:\n\n  1. Cohort B1 (Biliary Tract Cancer)\n  2. Cohort B2 (Ovarian Cancer)\n  3. Cohort B3 (Breast Cancer)\n  4. Cohort B4 (Endometrial Cancer)\n  5. Cohort B5 (Squamous Non-Small Cell Lung Cancer)\n\n     Additional Inclusion Criteria For Sub-Study 2 Part A:\n* Minimum body weight ≥ 30 kg.\n* Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer.\n\nAdditional Inclusion Criteria For Sub-Study 3 Part A:\n\n* Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).\n* Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, ovarian cancer, BTC, endometrial cancer or squamous non-small cell lung cancer.\n\nAdditional Inclusion Criteria For Sub-Study 4 Part A:\n\n* Minimum body weight ≥ 30 kg (for participants enrolled in cohorts including rilvegostomig only).\n* Histologically or cytologically confirmed metastatic or locally advanced\u002Frecurrent breast cancer, endometrial cancer or squamous non-small cell lung cancer.\n* Participants must have progressed following at least one but no more than 3 prior lines of treatment for metastatic or relapsed disease and have no satisfactory alternative treatment option as judged by the Investigator.\n\nKey Exclusion Criteria:\n\n* Treatment with any of the following:\n\n  1. Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment\n  2. Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment\n  3. Any other anticancer treatment within the following time periods prior to the first dose of study intervention:\n\n     1. Cytotoxic treatment: 21 days\n     2. Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)\n     3. Biological products including immuno-oncology agents: 28 days\n* Spinal cord compression or a history of leptomeningeal carcinomatosis.\n* Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \\> 10 mg prednisone\u002Fday or equivalent for at least 4 weeks prior to start of study.\n* Active infection including tuberculosis and HBV, HCV or HIV\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Participants with any of the following cardiac criteria:\n\n  1. History of arrhythmia which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3); symptomatic or uncontrolled atrial fibrillation, or asymptomatic sustained ventricular tachycardia.\n  2. Uncontrolled hypertension.\n  3. Acute coronary syndrome\u002Facute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months.\n  4. History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.\n  5. Symptomatic heart failure (NYHA class ≥ 2).\n  6. Prior or current cardiomyopathy.\n  7. Severe valvular heart disease.\n  8. Mean resting QTcF \\> 470 msec.\n  9. Risk factors for QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.\n* Patients with history of myelodysplastic syndrome (MDS)\u002Facute myeloid leukemia (AML) or with features suggestive of MDS\u002FAML (as determined by prior diagnostic investigation)\n\nAdditional Exclusion Criteria For Sub-Study 2 Part A:\n\n* Thromboembolic event within 3 months before the first dose of study intervention - No longer applicable per amendment 7\n* Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n* Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n* History of organ transplant\n\nAdditional Exclusion Criteria For Sub-Study 2 Part B\n\n• Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)\n\nAdditional Exclusion Criteria For Sub-Study 3 Part A:\n\n* Concomitant use of medications or herbal supplements known to be strong cytochrome P (CYP) 3A4 inducers\u002Finhibitors.\n* Any history of persisting (\\> 2 weeks) severe cytopenia due to any cause\n* Patients with any known predisposition to bleeding\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of saruparib.\n* Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)\n\nAdditional Exclusion Criteria For Sub-Study 4 Part A:\n\n* Patients have received prior therapy with AZD9574 or more than 1 prior line of any other PARPi-based regimen\n* Concomitant use of medications or herbal supplements known to be strong cytochrome P (CYP) 3A4 inducers\u002Finhibitors.\n* Previous treatment with rilvegostomig for the cohort treated with rilvegostomig\n* Previous treatment with any therapy that contains a TOP1i (eg. irinotecan, topotecan, trastuzumab deruxtecan, etc.)\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9574",{"count":104,"type":20},460,[23,24],"This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents",[108,109,110,111,112],"Breast Cancer","Biliary Tract Carcinoma","Ovarian Cancer","Endometrial Cancer","Squamous Non-Small Cell Lung Cancer",[114],"First In Human, antibody drug conjugate, cancer, solid tumour, Phase I, Phase IIa","2026-06-16",{"date":117,"type":42},"2026-06-17",{"date":119,"type":42},"2021-10-18",{"date":121,"type":20},"2027-09-29",{"name":123,"class":49},"AstraZeneca",67,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100620631","phase-3-phase-iii-clinical-study-of-hb0025-combined-with-chemotherapy-versus-pembrolizumab-combined-with-chemotherapy-for-the-first-line-treatment-of-advanced-squamous-non-small-cell-lung-cancer-100620631","NCT07360132","Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer","A Randomized, Double-Blind, Multicenter Phase III Clinical Study of HB0025 Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-Line Treatment of Advanced or Metastatic Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Able to fully understand and voluntarily sign the informed consent form, and willing and able to comply with the clinical study procedures and follow-up visits.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.\n3. Expected survival ≥ 12 weeks.\n4. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) (confirmed per the 9th Edition of the TNM Staging System for Lung Cancer by the Union for International Cancer Control \\[UICC\\] and the American Joint Committee on Cancer \\[AJCC\\]) that is inoperable for radical resection and ineligible for radical concurrent\u002Fsequential chemoradiotherapy or immunotherapy as consolidation treatment.\n\nNote: For subjects with locally advanced (Stage IIIB\u002FIIIC) NSCLC who are inoperable for radical resection and ineligible for radical concurrent\u002Fsequential chemoradiotherapy or immunotherapy as consolidation treatment, an assessment by relevant specialist physicians and provision of written documentation are required for confirmation.\n\n6\\. No previous systemic anti-tumor treatment for locally advanced or metastatic squamous NSCLC \\[For subjects who have received adjuvant\u002Fneoadjuvant therapy for the purpose of cure for non-metastatic disease or radical concurrent\u002Fsequential chemoradiotherapy for locally advanced disease (including subjects receiving PD-1\u002FL1 inhibitors), If disease progression occurs more than 12 months after the end of the last treatment, one is eligible to participate in this study.\n\n7\\. Subjects must provide tumor tissue samples (archived or freshly obtained) collected at or after the diagnosis of locally advanced or metastatic tumor for central laboratory testing of PD-L1 expression.\n\nNote:The following samples are not accepted: fine-needle aspiration samples (without intact tissue structure, only cell suspensions or smears), brush cytology samples, cell smears from centrifuged pleural effusion drainage, bronchoalveolar lavage fluid samples, and bone lesions without soft tissue components or decalcified bone tumor samples.\n\n8\\. No sensitive EGFR mutations or ALK gene rearrangements. Prior tissue-based test reports for EGFR and ALK status must be provided. If the test reports do not meet the study requirements or are unavailable, tumor tissue samples must be provided for assessment of EGFR and ALK status (tested by a local laboratory recognized by the study site or the central laboratory) before enrollment.\n\nNote: For subjects with squamous NSCLC (excluding mixed-type NSCLC, e.g., adenosquamous carcinoma) who have a smoking history or are current smokers, if the prior EGFR and ALK status is unknown, testing for these markers is not required before enrollment, and they will be deemed negative.\n\n9\\. At least one measurable (non-brain metastatic) lesion per RECIST v1.1 criteria, which is suitable for repeated and accurate measurement. Tumor lesions previously treated with radiotherapy or other local therapies cannot be designated as target lesions, unless:\n\n* The lesion is the only measurable lesion, and the investigator can provide imaging evidence (before and after local treatment) confirming clear disease progression of the lesion after local treatment;\n* The lesion used for fresh tissue biopsy is the only measurable lesion. 10. Confirmed adequate organ function, as evidenced by meeting the following laboratory parameters: 1) Hematology (no receipt of blood component transfusion or hematopoietic growth factor support within 14 days before screening tests):\n\n  1. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL;\n  2. Platelet Count (PLT) ≥ 100 × 10⁹\u002FL;\n  3. Hemoglobin (HGB) ≥ 90 g\u002FL; 2) Renal function:\n\n  a) Serum Creatinine (Scr) ≤ 1.5 × Upper Limit of Normal (ULN), and Creatinine Clearance (Ccr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula); b) Urine protein \\\u003C 2+; if urine protein ≥ 2+, 24-hour urine protein excretion must be \\\u003C 1 g; 3) Hepatic function:\n  1. Serum Total Bilirubin (TBiL) ≤ 1.5 × ULN;\n  2. Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN; for subjects with liver metastasis, ALT and AST ≤ 5 × ULN;\n  3. Serum Albumin (ALB) ≥ 30 g\u002FL; 4) Coagulation function: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and International Normalized Ratio (INR) ≤ 1.5 × ULN (for subjects receiving anticoagulant therapy, the investigator must confirm that INR, APTT, and PT are within the safe and effective therapeutic range); 5) Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 50% 11. The toxicity of previous treatment has been restored to grade 0 or 1 of NCI CTCAE version 5.0, or the level specified in the inclusion\u002Fexclusion criteria (except for alopecia). Note: For subjects who experience irreversible toxicity and whose condition is not expected to worsen after administration of the study drug (such as those with hearing loss), they may be included in the study after consultation with medical monitors.\n\n     12\\. Female and male subjects of childbearing potential must agree to use effective contraceptive measures from the screening period until 90 days after the last dose of study treatment. Discussion with the investigator is required to determine whether contraception can be discontinued after this period. Female subjects must not be breastfeeding. Female subjects of childbearing potential must have a negative serum pregnancy test result within 7 days before randomization.\n\n     Exclusion Criteria:\n     1. Histologically confirmed presence of any small cell carcinoma, neuroendocrine carcinoma, or sarcoma components \\[mixed-type NSCLC (e.g., adenosquamous carcinoma) is permitted for enrollment\\].\n     2. Known presence of driver gene alterations with approved first-line therapeutic options, such as sensitive EGFR mutations, ALK fusion, ROS1 fusion, BRAF V600 mutation, NTRK fusion, MET exon 14 skipping mutation, or RET fusion.\n     3. History of a second primary malignancy within 3 years before Randomization (enrollment is permitted for other malignancies cured by local treatment, e.g., carcinoma in situ of the cervix, localized cutaneous squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ of the breast, \\\u003C T1 urothelial carcinoma, and papillary microcarcinoma of the thyroid).\n     4. Symptomatic central nervous system (CNS) metastasis; or diameter of brain metastases ≤ 1.5 cm, or receipt of CNS radiotherapy within 2 weeks before randomization; or anticipated need for CNS radiotherapy during the first treatment cycle after randomization. Subjects with asymptomatic CNS metastasis or symptomatically stable CNS metastasis (≥ 2 weeks before randomization) are permitted for enrollment only if all the following criteria are met:\n\n        * No increase in lesion size or new lesions after treatment; ② No history of intracranial hemorrhage;\n\n          * Discontinuation of corticosteroid therapy \\> 3 days before randomization;\n\n            * Diameter of brain metastases \\\u003C 1.5 cm.\n     5. Prior receipt of immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1\u002FL1\u002FL2, anti-CTLA-4 agents), immune checkpoint agonists (e.g., ICOS, CD40, GITR, OX40, CD137 agents), or cellular immunotherapy, or any treatment targeting the tumor immune mechanism. Additionally, for subjects who received PD-(L)1 inhibitors in the neoadjuvant\u002Fadjuvant setting or as consolidation therapy after definitive chemoradiotherapy, enrollment may be permitted (with sponsor approval) if disease progression occurs \\> 12 months after the last dose of prior treatment.\n     6. Prior receipt of systemic anti-angiogenic therapy, including but not limited to bevacizumab and its biosimilars, Endostar, small-molecule TKIs, and ramucirumab.\n     7. Prior antineoplastic treatment or concomitant medication use (washout period calculated from the end of the last treatment):\n\n  \u003C!-- -->\n\n  1. Concurrent enrollment in another clinical trial, unless it is an observational, non-interventional clinical trial or the follow-up phase of an interventional clinical trial (defined as an interval of ≥ 4 weeks between the last dose of the previous study drug and randomization in this study);\n  2. Receipt of chest radiotherapy with \\> 30 Gy within 180 days before randomization; non-chest radiotherapy with \\> 30 Gy within 4 weeks before randomization; local palliative radiotherapy with ≤ 30 Gy for non-target lesions within 2 weeks before randomization;\n  3. Use of Chinese herbal medicines (with antineoplastic indications) within 1 week before randomization; receipt of non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, tumor necrosis factor, excluding IL-11 for thrombocytopenia treatment) within 2 weeks before randomization;\n  4. Need for systemic use of corticosteroids (≥ 10 mg\u002Fday prednisone or equivalent) or other immunomodulators within 2 weeks before randomization \\[short-term use (≤ 7 days) for prophylaxis (e.g., contrast agent allergy) or treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reaction to allergens), or topical use (e.g., intraocular, intra-articular, intranasal, or inhaled administration) is permitted\\].\n  5. Subjects who are currently using preventive or full-dose anticoagulants or antiplatelet drugs for therapeutic purposes and have not reached a stable state before randomization will not be enrolled. According to the medical standards of the enrolling institution, as long as the INR, PT and APTT of the subjects are within the therapeutic range and they have used or are currently using anticoagulants or antiplatelet drugs, they can be enrolled.\n\n     8\\. Major surgery or severe trauma within 4 weeks before the first dose of study treatment; inadequate recovery from prior surgery (as judged by the investigator); anticipated need for major surgery during the study; minor local surgery (e.g., needle biopsy, endoscopy, interventional procedure\u002Fexamination, excluding vascular access establishment) within 7 days before randomization; presence of incompletely healed surgical incisions or wounds.\n\n     9\\. Active autoimmune disease requiring systemic treatment (e.g., treatment with immunomodulators or corticosteroids) within 2 years before randomization, except for replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency).\n\n     10\\. Presence of any of the following infections:\n\n  \u003C!-- -->\n\n  1. Severe infection (including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia) within 4 weeks before the first dose of study treatment; active infection requiring systemic anti-infective treatment (with antibiotics for ≥ 7 days) within 2 weeks before randomization;\n  2. Known active tuberculosis (TB) (subjects with suspected active TB must undergo clinical examination to rule out the diagnosis);\n  3. Known active syphilis infection;\n  4. Has a known history of HIV;\n  5. Active hepatitis B or hepatitis C; asymptomatic hepatitis B virus (HBV) carriers (HBV DNA ≤ 200 IU\u002Fml or ≤ 1000 copies\u002Fml or below the lower limit of detection, whichever is applicable) or subjects with clinically cured hepatitis C (HCV RNA below the lower limit of detection) are permitted for enrollment.\n\n     Note: Anti-HBV treatment is required for HBsAg-positive subjects during the study treatment period.\n\n     11\\. Known hypersensitivity to protein drugs, recombinant proteins, components of HB0025, and\u002For components of chemotherapy drugs (pemetrexed and carboplatin\u002Fcisplatin).\n\n     12\\. Uncontrolled arterial hypertension despite standard treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).\n\n     13\\. Those with a history of non-infectious pneumonia requiring systemic corticosteroid treatment in the past, or currently having interstitial lung disease, pneumoconiosis, drug\u002Fradiation-related pneumonia that requires treatment, or those with severe functional impairment indicated by pulmonary function tests.\n\n     14\\. Presence of any of the following severe comorbidities:\n\n  \u003C!-- -->\n\n  1. Clinically significant bleeding (including but not limited to hemoptysis \\[defined as coughing up or expectorating ≥ 1 teaspoon (approximately 5 ml) of fresh blood or small blood clots, or hemoptysis without sputum; subjects with blood-tinged sputum or transient hemoptysis related to diagnostic bronchoscopy or lung biopsy are permitted\\], gastrointestinal bleeding, nasal bleeding \\[subjects with bloody nasal discharge are permitted\\]) within 4 weeks before the first dose of study treatment; any arterial thrombosis or embolism event, or significant vascular disease (e.g., aortic aneurysm, aortic dissection) within 180 days before the first dose of study treatment; history of deep vein thrombosis within 90 days before the first dose of study treatment;\n  2. Imaging findings at screening showing: Tumor invasion of large blood vessels (e.g., central pulmonary artery, central pulmonary vein, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava); tumor invasion of vital organs (e.g., heart, trachea, esophagus, main bronchus); or imaging evidence of risk for esophagotracheal fistula or esophagopleural fistula; tumor encasement of large blood vessels with vascular stenosis; or pulmonary lesions with obvious necrosis\u002Fcavitation (as judged by the investigator to pose a bleeding risk if enrolled);\n  3. History of persistent bleeding disorders or coagulation disorders (past or current);\n  4. Clinically significant (e.g., active) cardiovascular or cerebrovascular disease within 180 days before the first dose of study treatment, including but not limited to unstable angina requiring hospitalization, myocardial infarction, myocarditis, cardiomyopathy, New York Heart Association (NYHA) Class ≥ II congestive heart failure, poorly controlled severe arrhythmia, transient ischemic attack (TIA), cerebrovascular accident (CVA), or vascular disease (e.g., aortic aneurysm at risk of rupture); or other cardiac impairment that may affect the safety evaluation of study drugs (e.g., poorly controlled arrhythmia, myocardial ischemia); Fridericia-corrected QT interval (QTcF) \\> 480 ms at screening, or history of congenital long QT syndrome or family history of the syndrome;\n  5. History of conditions potentially causing gastrointestinal bleeding or perforation (e.g., gastrointestinal obstruction, acute Crohn's disease, ulcerative colitis, esophagogastric varices, gastrointestinal perforation, unhealed wound, intra-abdominal abscess, or acute gastrointestinal bleeding) within 180 days before the first dose of study treatment; subjects with chronic Crohn's disease or ulcerative colitis (excluding those who have undergone total colectomy and proctectomy) are excluded, even if in remission;\n  6. History of gastrointestinal fistula or genitourinary fistula (past or current) that remains unhealed after surgical treatment;\n  7. Hydronephrosis unrelieved by nephrostomy or ureteral stenting, or infected hydronephrosis\u002Fhydroureter;\n  8. Current presence of third-space fluid collections (e.g., pleural effusion, pericardial effusion, abdominal\u002Fpelvic effusion) requiring repeated puncture\u002Fdrainage for local management; or receipt of local drainage within 2 weeks before the first dose of study treatment;\n  9. Acute exacerbation of chronic obstructive pulmonary disease within 30 days before the first dose of study treatment;\n  10. Current presence of uncontrolled comorbidities, including but not limited to decompensated liver cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, severe active peptic ulcer disease or gastritis (enrollment decision requires joint discussion between the investigator and the sponsor).\n\n      15\\. Pregnant or lactating women, or those planning to breastfeed during the study period.\n\n      16\\. There is a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\n      17\\. Live virus vaccine or attenuated live vaccine was received within 30 days before randomization, or vaccination was planned during the study period (Note: Inactivated vaccine is allowed).\n\n      18\\. It is known that there is a history of mental illness, alcoholism, drug abuse or substance abuse.\n\n      19\\. There have been or are currently uncontrolled metabolic disorders, local or systemic diseases not caused by tumors, secondary diseases or symptoms of tumors, abnormal laboratory tests or any treatments that may lead to higher medical risks and\u002For confuse research results, interfere with the subjects' participation in the entire study, or participation in the study may not be in the best interests of the subjects.\n\n      20\\. Subjects who, as assessed by the researchers, are not suitable to participate in the trial for other reasons.","75 Years",{"count":134,"type":20},480,[136],"PHASE3","This study is a randomized, controlled, double-blind, multi-center phase III registration clinical trial, aiming to observe, compare and evaluate the efficacy and safety of HB0025 combined with paclitaxel + carboplatin compared with pembrolizumab combined with paclitaxel + carboplatin as the first-line treatment for locally advanced or metastatic squamous NSCLC.\n\nThe study subjects are patients with locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) who have not received systemic anti-tumor treatment before. The study will use the PFS evaluated by BICR as the primary endpoint, and plan to enroll approximately 480 subjects, with the proportion of locally advanced subjects not exceeding 10%.\n\nThe subjects were fully informed and signed the informed consent form. If they met the inclusion criteria but did not meet the exclusion criteria, they were randomly assigned in a 1:1 ratio to receive HB0025 combined with chemotherapy Paclitaxel plus Platinum (experimental group) or pembrolizumab combined with chemotherapy Paclitaxel plus Platinum (control group). Both were administered once every 3 weeks (Q3W). After 4 cycles of treatment, Enter HB0025 or pembrolizumab monotherapy maintenance treatment (Q3W) until the investigator determines that there is no longer any clinical benefit (based on the RECIST v1.1 imaging assessment and comprehensive clinical symptom assessment by the investigator), intolerable toxicity occurs, 24 months of study treatment is completed, or other treatment termination criteria in the protocol are met. Whichever occurs first shall prevail.",[86],[140,141,142],"HB0025","sq-NSCLC","Fiest Line treatment","NOT_YET_RECRUITING","2026-01-13",{"date":146,"type":42},"2026-01-22",{"date":148,"type":20},"2026-01-15",{"date":150,"type":20},"2028-08-10",{"name":152,"class":49},"Shanghai Huaota Biopharmaceutical Co., Ltd.",1,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":21,"phases":163,"briefSummary":164,"conditions":165,"keywords":174,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100508635","phase-1-a-phase-iii-study-of-vls-1488-in-subjects-with-advanced-cancer-100508635","NCT05902988","A Phase I\u002FII Study of VLS-1488 in Subjects With Advanced Cancer","A Phase I\u002FII Study of VLS-1488 (an Oral KIF18A Inhibitor) in Subjects With Advanced Cancer","Key Inclusion Criteria:\n\n* All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration\n* Dose Escalation: No available therapeutic options to provide clinically meaningful benefits in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non -Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Gastroesophageal Junction, Bladder (transitional cell), Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), Ovarian Carcinosarcoma, CN-high Endometrial\u002FUterine\n* Dose Expansion: Must have been previously treated with several lines of standard of care treatment specified in the protocol in the following tumor types: High Grade Serous Ovarian Cancer, Squamous Non-Small Cell Lung Cancer, Triple Negative Breast Cancer, Gastric Adenocarcinoma (not EBV+), Colorectal, Esophageal Squamous Cell Carcinoma, Esophageal Adenocarcinoma, Head and Neck Squamous Cell Carcinomas (not nasopharynx, sinonasal or lip), CN-high Endometrial\u002FUterine\n\nKey Exclusion Criteria:\n\n* MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype\n* Previously received KIF18A inhibitor\n* Current CNS metastases or leptomeningeal disease\n* Cardiac parameters: MI or stroke ≤ 1 year, unstable angina\u002FPE\u002FDVT\u002FCABG ≤ 6 months, NYHA Class ≥ II, LVEF \\\u003C 50%\n* Inability to comply with concomitant medication restrictions with respect to strong inhibitors and inducers of CYP3A, and clinical inhibitors of MDR1 (P-gp) and BCRP\n* Any clinically significant ascites or pleural effusions at time of enrollment, or any therapeutic paracentesis or thoracentesis within 28 days of planned first dose of study drug\n* Bowel obstruction or GI perforation within 6 months of planned first dose of study drug",{"count":162,"type":20},200,[23,24],"This is a first-in-human phase I\u002FII study to examine the safety, tolerability and preliminary efficacy of VLS-1488 in subjects with advanced cancers.",[166,167,28,168,63,169,170,171,172,173],"Advanced Solid Tumor","High Grade Serous Adenocarcinoma of Ovary","Triple Negative Breast Cancer","Ovarian Carcinosarcoma","Uterine Carcinosarcoma","Uterine Serous Carcinoma","Endometrium Cancer","Chromosomal Instability",[175,176,177,178,179],"KIF18A Inhibitor","HGSOC","TNBC","HNSCC","sqNSCLC","2025-10-31",{"date":182,"type":42},"2025-11-04",{"date":184,"type":42},"2023-10-18",{"date":186,"type":20},"2026-12",{"name":188,"class":49},"Volastra Therapeutics, Inc.",14]