[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lung-squamous-cell-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lung-squamous-cell-carcinoma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,59,90,120,152,177,203,229],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100500508","phase-1-phase-iiia-study-of-azd5335-as-monotherapy-and-combination-therapy-in-participants-with-solid-tumors-100500508",false,"NCT05797168","Phase I\u002FIIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors","A Modular Phase I\u002FIIa, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors","FONTANA","Core Inclusion Criteria:\n\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Participants who do not provide informed consent for Optional Genetic Research may still be enrolled in the study.\n* Participant must be ≥ 18 years at the time of signing the informed consent.\n* Willing to provide adequate archival and\u002For baseline tumor sample as applicable per module-specific criteria.\n* For participants who have previously received targeted therapies such as ADCs, a fresh baseline biopsy will be required unless the most recent archival tissue sample was collected after receipt of such treatment.\n* Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, 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. Participants with contraindications or who refuse therapy in accordance with local practice may also be considered provided that it is documented that he\u002Fshe was informed about all therapeutic options.\n* Participants must have measurable disease per RECIST v1.1,\n\n  1. A previously irradiated lesion can be considered a target lesion if the lesion is progressing and well defined.\n  2. For participants who undergo biopsies at screening and\u002For on treatment, it is preferred though not required, that the biopsied lesion, be distinct from any target lesion used in the RECIST v1.1 evaluation.\n* Life expectancy ≥ 12 weeks.\n* Adequate organ and marrow function.\n* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n  (a) Male participants: (i) Male participants who are sexually active with a female partner of childbearing potential must use a male condom (plus an additional contraceptive method) post-screening for at least 8 months following the last dose of study intervention. It is strongly recommended for the female partner of a male participant to also use a highly effective method of contraception throughout this period. In addition, male participants must refrain from freezing or donating sperm while on study and for 8 months following the last dose of study intervention.\n\n  (b) Female participants : (i) Females of childbearing potential must have a negative serum pregnancy test result within 72 hours prior to receiving the first dose of study intervention and a negative urine or serum pregnancy test prior to starting their next cycle of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n(ii) (ii) Sex and Contraceptive\u002FBarrier Requirements: Highly effective birth control methods include: Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) \\[(periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception\\], a vasectomized partner, Implanon®, bilateral tubal occlusion, intrauterine device\u002Flevonorgestrel intrauterine system, Depo Provera™ injections, oral contraceptive associated with inhibition of ovulation, and Evra Patch™, Xulane™, or NuvaRing®.\n\nFemale participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly), from enrolment throughout the study and for 8 months following the last dose of study intervention. The male partner of a female participant of childbearing potential must also use a male condom (plus spermicide, if available) throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. In addition, female participants must not donate or retrieve for their own use, ova while on study and for 8 months following the last dose of study intervention.\n\nCore Exclusion Criteria:\n\n* Patients with spinal cord compression or a history of leptomeningeal carcinomatosis.\n* Patients with brain metastases unless, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \\> 10 mg prednisone\u002Fday or equivalent for at least 4 weeks prior to first dose of study intervention.\n* Treatment with any of the protocol defined medications, without adequate washout periods or time before the first dose of study intervention.\n* Unresolved toxicities of Grade ≥ 2 (National Cancer Institute \\[NCI\\] CTCAE v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy). Participants with stable ≤ Grade 2 neuropathy are eligible.\n* Active infection, including tuberculosis and infections with hepatitis B virus (HBV; verified by known positive hepatitis B surface antigen \\[HBsAg\\] result), hepatitis C virus (HCV) or known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥ 350\u002Fmm3, no history of acquired immune deficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen).\n\nPatients with a past or resolved HBV\u002FHCV infection are eligible if:\n\n1. Negative for HBsAg and positive for anti-hepatitis B virus core protein (HBc) or\n2. Are HBsAg + with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below:\n\n(i) HBV DNA viral load \\\u003C100 IU\u002FmL. (ii) Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C3 x upper limit of normal (ULN), which are not attributable to HBV infection.\n\n(iii) Start or maintain antiviral treatment if clinically indicated as per the Investigator or as per local guideline.\n\nNote for Japan: Japanese patients with positive anti-HBs\u002Fanti-HBc and negative HBsAg will be assessed following local guidelines.\n\n(c) Participants testing positive for HCV antibody are eligible only if the polymerase chain reaction test result is negative for HCV RNA.\n\n* Patient has active ILD\u002Fpneumonitis or has a history of (non-infectious) ILD\u002Fpneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n\n  * Patients with a history of radiation pneumonitis which has clinically and radiologically resolved and not requiring treatment with steroids may be eligible.\n* History of another malignancy except for:\n\n  * Malignancy treated with curative intent and with no known active disease for at least 2 years prior to screening of study intervention and with low potential risk for recurrence.\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n  * Adequately treated carcinoma in situ without evidence of disease.\n  * Localized non-invasive solid organ primary disease under surveillance.\n* Patients with any of the following cardiac criteria:\n\n  * History of arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, and ventricular tachycardia), which is symptomatic or requires treatment NCI CTCAE v5.0 Grade 3 except for:\n\n    (i) Rate controlled asymptomatic atrial fibrillation.\n    * NOTE: significant abnormalities in serum electrolytes that can increase the risk of arrhythmic events (ie, sodium, potassium, calcium, and magnesium) should be corrected before starting the study intervention.\n  * Uncontrolled hypertension.\n  * Acute coronary syndrome\u002Facute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months of screening.\n  * History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.\n  * Symptomatic heart failure (as defined by New York Heart Association class ≥ 2).\n  * Prior or current diagnosis of cardiomyopathy considered clinically relevant per investigator's judgement.\n  * Severe uncorrected valvular heart disease.\n  * Mean resting QTcF \\> 470 msec obtained from triplicate electrocardiograms (ECGs) and averaged, recorded within 5 minutes.\n  * Any factor that, in the opinion of the investigator, increases the proarrhythmic risk of QT prolongation, such as congenital long QT syndrome, family history of long QT syndrome, hypertrophic cardiomyopathy, or unexplained sudden cardiac death under 40 years of age.\n* Uncontrolled and\u002For unresolved intercurrent illness within 12 months prior to screening, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, or illness (including psychiatric illness) and\u002For social situations, in the opinion of the investigator, that would limit compliance with study requirements and activities, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.\n* Substance abuse or any other medical conditions that would increase the safety risk to the participant or interfere with participation of the participant or evaluation of the clinical study in the opinion of the Investigator.\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants, if enrolled, should not receive live vaccine whilst receiving study intervention and up to 3 months after the last dose of study intervention. Participants can receive Coronavirus (COVID)-19 vaccines, at the discretion of the Investigator, following a benefit\u002Frisk evaluation for the individual participant and in accordance with local rules and regulations and vaccination guidelines. Note: If a COVID-19 vaccine is administered it should be done \\> 72 hours prior to study intervention initiation or after completion of the DLT period.\n* For women only - currently pregnant (confirmed with positive pregnancy test or suspected), lactating, breastfeeding, or intention to become pregnant during the study period.\n* Concurrent enrolment in another clinical study, unless it is an observational (non interventional) clinical study or during the follow-up period of an interventional study. Exception: Diagnostic imaging evaluation studies (e.g. PET) may be allowed subject to case-by-case discussion with the Sponsor.\n* Patients with a known hypersensitivity to study intervention or any of the excipients of the product.\n* Involvement in the planning and\u002For conduct of the study (applies to both AstraZeneca staff and\u002For staff at the study site).\n* Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Previous enrolment in the present study. \\*\\*Other module specific criteria may apply","ALL","18 Years","130 Years",{"count":21,"type":22},506,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors",[29,30,31,32],"Ovarian Cancer","Lung Adenocarcinoma","Endometrial Cancer","Lung Squamous Cell Carcinoma",[34,35,36,37,38,39,40,41,42,43,44,45,29,30,31,32],"ADC","PARP inhibitor","AZD5335","Torvutatug Samrotecan","Torvu-sam","AZD5305","Saruparib","Bevacizumab","Carboplatin","AZD9574","Palacaparib","Pembrolizumab","RECRUITING","2026-06-02",{"date":49,"type":50},"2026-06-03","ACTUAL",{"date":52,"type":50},"2023-06-05",{"date":54,"type":22},"2028-01-06",{"name":56,"class":57},"AstraZeneca","INDUSTRY",60,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":23,"phases":68,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100640654","phase-2-intermittent-hypoxic-training-as-neoadjuvant-therapy-for-lung-squamous-cell-carcinoma-100640654","NCT07618793","Intermittent Hypoxic Training as Neoadjuvant Therapy for Lung Squamous Cell Carcinoma","Study on the Novel Application of Intermittent Hypoxic Training in Neoadjuvant Therapy for Lung Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age between 18 and 75 years old (inclusive), regardless of sex.\n2. Diagnosed with histologically confirmed stage II-IIIA (according to the AJCC 8th edition staging system) squamous cell lung carcinoma.\n3. The primary tumor is evaluated by a multidisciplinary team (MDT) and deemed completely resectable.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n5. Life expectancy of at least 6 months.\n6. Adequate organ, bone marrow, and coagulation functions, meeting the following laboratory criteria within 7 days prior to enrollment:\n\n   * Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL;\n   * Platelet count \\>= 100 x 10\\^9\u002FL;\n   * Hemoglobin \\>= 90 g\u002FL;\n   * Total bilirubin \\\u003C= 1.5 x upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \\\u003C= 2.5 x ULN;\n   * Serum creatinine \\\u003C= 1.5 x ULN, or creatinine clearance \\>= 50 mL\u002Fmin;\n   * International normalized ratio (INR) and activated partial thromboplastin time (APTT) \\\u003C= 1.5 x ULN.\n7. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during the study and for at least 6 months after the last dose. Male participants must agree to use effective contraception during the study and for at least 6 months after the last dose.\n8. Participant understands the study protocol, voluntarily participates, and signs the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. Histologically confirmed small cell lung cancer, adeno-squamous carcinoma, large cell neuroendocrine carcinoma, or adenocarcinoma (including components of these types).\n2. Patients with driver gene mutations that have approved targeted therapies available (e.g., EGFR mutations, ALK rearrangements, ROS1 fusions, etc.).\n3. Prior systemic antitumor therapy for lung cancer, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or definitive surgical resection.\n4. Active, known, or suspected autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis), or a history of autoimmune disease within the past 2 years.\n5. History of other malignant tumors within the past 5 years, except for adequately treated cured skin basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ (e.g., cervical carcinoma in situ).\n6. Severe cardiovascular or cerebrovascular diseases, including but not limited to:\n\n   * Myocardial infarction or unstable angina within the past 6 months;\n   * New York Heart Association (NYHA) Class III or IV congestive heart failure;\n   * Clinically significant ventricular arrhythmia or poorly controlled symptomatic arrhythmia;\n   * Stroke or transient ischemic attack (TIA) within the past 6 months.\n7. Poorly controlled hypertension (systolic blood pressure \\>= 160 mmHg and\u002For diastolic blood pressure \\>= 100 mmHg despite standard antihypertensive therapy).\n8. Chronic obstructive pulmonary disease (COPD) or other respiratory diseases with severe lung function impairment (e.g., FEV1 \\\u003C 50% predicted value, or requiring long-term home oxygen therapy).\n9. Active infections requiring systemic intravenous anti-infective treatment within 2 weeks prior to enrollment (e.g., severe pneumonia, bacteremia), or active tuberculosis infection.\n10. Known history of human immunodeficiency virus (HIV) infection, or active Hepatitis B (HBV DNA \\>= 500 IU\u002FmL or copy number above detection limit) or active Hepatitis C (HCV RNA positive).\n11. History of interstitial lung disease (ILD), drug-induced pneumonitis, radiation pneumonitis requiring steroid treatment, or evidence of active pneumonitis.\n12. Severe claustrophobia, severe high-altitude sickness history, or other medical\u002Fpsychological conditions that prevent compliance with intermittent hypoxic training (IHT) using the FLY-2265 low oxygen system.\n13. Pregnant or breastfeeding women.\n14. Any other medical condition, clinical laboratory abnormality, or social circumstance that, in the opinion of the investigator, may compromise participant safety, interfere with the evaluation of study interventions, or affect compliance with study procedures.","75 Years",{"count":58,"type":22},[26],"The goal of this clinical trial is to learn if adding intermittent hypoxic training (IHT) to standard neoadjuvant chemo-immunotherapy can increase the pathologic complete response (pCR) rate in patients aged 18 to 75 of both sexes with resectable stage II-IIIA lung squamous cell carcinoma. The main questions it aims to answer are:Can the addition of IHT to standard neoadjuvant chemo-immunotherapy significantly improve the pathologic complete response (pCR) rate compared to standard therapy alone? Is IHT safe and well-tolerated in this perioperative setting, and can it improve 2-year recurrence-free survival (RFS) without increasing complications? Researchers will compare the experimental group (standard neoadjuvant chemo-immunotherapy combined with IHT) to the control group (standard neoadjuvant chemo-immunotherapy alone) to see if the combination safely enhances anti-tumor immune responses, improves tumor regression, and extends long-term survival. Participants will:Receive standard neoadjuvant chemo-immunotherapy for 4 cycles (21 days per cycle), consisting of nab-paclitaxel, carboplatin, and pembrolizumab. Undergo Intermittent Hypoxic Training (IHT) if randomized to the experimental group, using the FLY-2265 low oxygen system (13% $FiO\\_2$ for 5 minutes followed by 21% $FiO\\_2$ for 5 minutes per cycle; 10 cycles per session, twice daily) for 7 consecutive days starting on Day 1 of each chemo-immunotherapy cycle. Undergo surgery (VATS lobectomy and systematic lymph node dissection) 3 to 4 weeks after the completion of the 4th cycle, provided that the disease has not progressed. Complete regular post-operative follow-up visits (including chest CT scans, brain MRIs, bone scans, tumor markers, and peripheral blood immune monitoring) for up to 5 years to evaluate long-term outcomes.",[32,71],"Carcinoma, Non-Small-Cell Lung (NSCLC)",[32,73,74,75,76,77],"Intermittent Hypoxic Training","Neoadjuvant Chemoimmunotherapy","CD8-Positive T-Lymphocytes","Non-Small Cell Lung Cancer","Pathologic Complete Response","NOT_YET_RECRUITING","2026-05-25",{"date":81,"type":50},"2026-06-01",{"date":83,"type":22},"2026-06",{"date":85,"type":22},"2028-12",{"name":87,"class":88},"zhang yi","OTHER",1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":106,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100601379","phase-1-a-phase-12-trial-of-ter-2013-in-patients-with-solid-tumors-harboring-aktpi3kpten-pathway-alterations-100601379","NCT07109726","A Phase 1\u002F2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT\u002FPI3K\u002FPTEN Pathway Alterations","Key Inclusion Criteria\n\n* Metastatic or locally advanced, unresectable disease\n* No available treatment with curative intent\n* Presence of lesions to be evaluated per RECIST v1.1:\n\n  a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n* Advanced solid tumor malignancy harboring an eligible AKT\u002FPI3K\u002FPTEN pathway alteration detected by a sponsor approved test\n\nKey Inclusion Criteria for TER-2013 monotherapy arms:\n\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 dose escalation\\]: solid tumor malignancy b. \\[For TER-2013 cohort expansion\\]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma\n* Prior therapy:\n\n  1. \\[For TER-2013 dose escalation\\]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused\n  2. \\[For TER-2013 cohort expansion\\]: No more than 3 prior lines of treatment in the advanced setting\n\n     Key Inclusion Criteria for TER-2013 and fulvestrant combination arms\n* Histologically confirmed diagnosis of:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: HR+\u002FHER2- advanced unresectable or metastatic breast cancer b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n* Prior Therapy:\n\n  a. \\[For TER-2013 + fulvestrant dose escalation\\]: Received treatment with an AI containing regimen (single agent or in combination) b. \\[For TER-2013 + fulvestrant cohort expansion\\]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting\n\nKey Exclusion Criteria:\n\n* Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K\u002FAKT\u002FPTEN alteration\n* Clinically significant abnormalities of glucose metabolism\n* Active brain metastases or carcinomatous meningitis.\n* History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug\n* Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013\n* Prior therapy:\n\n  1. \\[For TER-2013 monotherapy escalation\\]: AKT inhibitor\n  2. \\[For TER-2013 monotherapy expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor\n  3. \\[For TER-2013 + fulvestrant combination expansion\\]: AKT\u002FPI3K\u002FPTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.\n\nOther protocol-defined Inclusion\u002FExclusion Criteria apply",{"count":97,"type":22},205,[25,26],"This is a Phase 1\u002F2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT\u002FPI3K\u002FPTEN pathway alterations.",[101,31,29,32,102,103,104,105],"Breast Cancer","Head and Neck Squamous Cell Carcinoma","Esophageal Squamous Cell Carcinoma","Solid Tumor","Cervical Cancer",[107,101,108,109],"AKT\u002FPI3K\u002FPTEN Alterations","Advanced Solid Tumors","HR+\u002FHER2-","2026-05-20",{"date":112,"type":50},"2026-05-22",{"date":114,"type":50},"2025-09-23",{"date":116,"type":22},"2029-02-28",{"name":118,"class":57},"Terremoto Biosciences Inc.",15,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":127,"enrollmentInfo":128,"targetDuration":130,"studyType":131,"phases":4,"briefSummary":132,"conditions":133,"keywords":137,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":4},"100623087","peripheral-blood-etasts-for-predicting-efficacy-of-chemoimmunotherapy-in-nsclc-100623087","NCT07392073","Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC","Prospective Study of Changes in Peripheral Blood Effector Tumor Antigen-Specific T Cells for Predicting Efficacy of Chemoimmunotherapy in Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)\n* Planned to receive PD-1 inhibitor combined with platinum-based chemotherapy (e.g., pembrolizumab + pemetrexed\u002Fcarboplatin)\n* Age 18-80 years\n* ECOG performance status 0-1\n* Expected survival ≥12 weeks\n* Adequate bone marrow function: ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL\n* Adequate hepatorenal function: Cr ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN\n* At least one measurable lesion per RECIST 1.1 criteria\n* Able to provide informed consent and comply with study procedures including serial blood sampling and imaging follow-up\n\nExclusion Criteria:\n\n* No measurable disease per RECIST 1.1 criteria\n* Tumor emergencies requiring immediate intervention (spinal cord compression, superior vena cava syndrome)\n* Active untreated central nervous system metastases or leptomeningeal disease\n* Prior treatment with immune checkpoint inhibitors within 4 weeks before enrollment\n* Chronic use of immunosuppressive agents (e.g., corticosteroids \\>10 mg\u002Fday prednisone equivalent)\n* Coagulation disorders (INR \\>1.5 or APTT \\>1.5×ULN) or ongoing anticoagulation therapy\n* Poor vascular access precluding serial venipuncture (\\>5 mL per draw)\n* Active hepatitis B (HBV DNA \\>2000 IU\u002FmL), hepatitis C, or HIV infection\n* Uncontrolled bacterial or fungal infection requiring systemic treatment\n* Pregnancy or lactation\n* Severe psychiatric disorder or communication barriers affecting informed consent or follow-up compliance\n\nWithdrawal Criteria:\n\n* Participant voluntary withdrawal with signed withdrawal statement\n* Major protocol violations: failure to receive ≥2 cycles of planned chemoimmunotherapy; missing ≥2 critical timepoint blood samples (baseline, cycle 2)\n* Uncontrollable grade ≥3 immune-related adverse events requiring permanent discontinuation of PD-1 inhibitor\n\nStudy Termination Criteria:\n\n* Disease progression confirmed by imaging per RECIST 1.1 or clinical progression requiring radiotherapy\n* Death or loss to follow-up \\>6 months\n* Unacceptable grade 4 treatment-related toxicity\n* Investigator determination that continued participation poses health risk to patient\n* Study terminated by ethics committee for scientific or administrative reasons","80 Years",{"count":129,"type":22},80,"24 Months","OBSERVATIONAL","The goal of this observational study is to explore whether changes in peripheral blood effector tumor antigen-specific T cells (ETASTs) can predict treatment outcomes in patients with advanced non-small cell lung cancer (NSCLC) receiving chemoimmunotherapy. The study aims to:\n\n* Evaluate the relationship between ΔETAST levels (baseline to cycle 2) and progression-free survival\n* Compare the predictive performance of ΔETASTs with traditional biomarkers (PD-L1, TMB)\n* Assess whether ΔETASTs can identify patients more likely to benefit from PD-1 inhibitor plus chemotherapy\n\nParticipants will:\n\n* Provide peripheral blood samples at baseline and after cycle 2 of treatment\n* Undergo ETAST quantification using the CTT-NanoDT technology with TATAN nanoparticles\n* Have standard tumor assessments every 2 cycles according to RECIST 1.1 criteria\n* Be followed for progression-free survival and overall survival up to 24 months",[76,30,32,134,135,136],"Stage IIIB Non-Small Cell Lung Cancer","Stage IV Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer",[138,139,140,141,142],"Tumor Antigen-Specific T Cells","Effector T Cells","Circulating T Cells","Biomarkers","PD-1 Inhibitor","2026-02-02",{"date":145,"type":50},"2026-02-06",{"date":147,"type":22},"2026-04",{"date":149,"type":22},"2029-06",{"name":151,"class":88},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":166,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":89},"100614090","phase-1-jmt106-injection-in-the-treatment-of-advanced-solid-tumors-100614090","NCT07275073","JMT106 Injection in the Treatment of Advanced Solid Tumors","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, Immunogenicity, and Preliminary Antitumor Activity of JMT106 Injection in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed advanced solid tumor.\n3. Failure of at least one line of standard therapy, or no standard treatment available, or intolerant to standard treatment at the current stage.\n4. At least one measurable lesion according to RECIST 1.1 criteria.\n5. ECOG performance status of 0-1.\n6. Expected survival ≥3 months.\n7. Sufficient organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factor treatment within 14 days):\n\n   1. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL;\n   2. Platelets (PLT) ≥90×10⁹\u002FL;\n   3. Hemoglobin (Hb) ≥90 g\u002FL;\n   4. Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for liver metastases or hepatocellular carcinoma);\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (≤5×ULN for liver metastases or hepatocellular carcinoma);\n   6. Creatinine clearance (Ccr) \\>50 mL\u002Fmin (calculated by Cockcroft-Gault formula);\n   7. Activated partial thromboplastin time (APTT) ≤1.5×ULN; INR ≤1.5×ULN.\n8. Fertile participants (male and female) must agree to use reliable contraception (hormonal, barrier, or abstinence) with their partners during the trial and for at least 180 days after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment.\n9. Understand and voluntarily sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Previous treatment with anti-GPC3 therapy.\n2. Presence of spinal cord compression or clinically active central nervous system metastases (untreated or symptomatic metastases, or those requiring corticosteroids\u002Fanticonvulsants for symptom control), or carcinomatous meningitis. Patients with previously treated brain metastases (e.g., whole-brain radiotherapy or stereotactic brain radiotherapy) may be enrolled if clinically stable for ≥4 weeks with no imaging evidence of progressive brain metastases.\n3. Long-term immunosuppressive therapy (e.g., cyclosporine) or daily systemic steroid therapy (e.g., \\>20 mg prednisone or equivalent), excluding those using nasal spray, inhaled, or other topical glucocorticoid therapies.\n4. Adverse reactions from prior antitumor therapy not recovered to CTCAE 5.0 Grade ≤1 (excluding toxicities deemed non-risky by the investigator, e.g., alopecia).\n5. Any antitumor therapy (chemotherapy, targeted therapy, immunotherapy, etc.) or investigational intervention within 4 weeks or 5 half-lives (whichever is shorter) before the first dose, or traditional Chinese medicine with antitumor indications within 14 days prior.\n6. Grade ≥3 immune-related adverse events (irAEs, per CTCAE 5.0) from prior immunotherapy.\n7. Concurrent participation in another interventional clinical trial (observational trials or follow-up phases allowed).\n8. Major surgery within 28 days before the first dose or planned tumor resection during the study.\n9. Significant bleeding tendency within 4 weeks before the first dose, or high-risk conditions (e.g., gastrointestinal hemorrhage, severe hemoptysis) per investigator judgment; hereditary bleeding disorders.\n10. Known severe allergy to the study drug or its excipients.\n11. Active bacterial, fungal, or viral infection requiring IV treatment within 14 days before randomization (prophylactic therapy allowed if no active infection symptoms); patients with viral hepatitis are allowed to receive antiviral treatment.\n12. Uncontrolled effusions (pleural, peritoneal, pericardial) requiring frequent drainage or intervention within 14 days before the first dose (excluding cytologic evaluation of effusions).\n13. History of allogeneic organ or hematopoietic stem cell transplantation.\n14. Immunodeficiency, including HIV-positive status.\n15. HBsAg-positive or HBcAb-positive with HBV-DNA \\>2000 IU\u002FmL; HCV antibody-positive with HCV-RNA positivity.\n16. History of tuberculosis treatment within 2 years before the first dose.\n17. Interstitial lung disease or severe pulmonary dysfunction.\n18. History of inflammatory bowel disease or chronic diarrhea.\n19. Severe cardiovascular\u002Fcerebrovascular disease, including:\n\n    1. Severe arrhythmias\u002Fconduction abnormalities (e.g., ventricular arrhythmias requiring intervention, AV block grade II-III);\n    2. Acute coronary syndrome, congestive heart failure, stroke, or other Grade ≥3 cardiovascular events within 6 months before the first dose;\n    3. NYHA class ≥II or LVEF \\\u003C50%;\n    4. Long QTc syndrome or QTc \\>480 ms (Fridericia formula), or concomitant use of QTc-prolonging drugs;\n    5. Uncontrolled hypertension (systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg at screening).\n20. Other active malignancies within 2 years (except cured localized tumors, e.g., basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, in situ prostate\u002Fcervical\u002Fbreast cancer).\n21. Live vaccination within 28 days before the first dose (inactivated vaccines, e.g., seasonal flu vaccine, allowed).\n22. Pregnancy or lactation.\n23. Other conditions deemed unsuitable by the investigator (e.g., depression history\u002Fcurrent treatment, psychiatric disorders affecting compliance, main portal vein tumor thrombus).",{"count":160,"type":22},200,[25],"This study is the first-in-human Phase I study of JMT106 injection, comprising two phases: Dose escalation with backfill and cohort expansion. The planned study population consists of subjects with advanced solid tumors. The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JMT106 injection as monotherapy in participants with advanced solid tumors",[164,32,165],"Advanced Solid Tumor","Hepatocellular Carcinoma",[167],"solid tumor","2025-12-10",{"date":170,"type":50},"2025-12-18",{"date":172,"type":50},"2025-09-25",{"date":174,"type":22},"2028-11-15",{"name":176,"class":57},"Shanghai JMT-Bio Inc.",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":66,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":186,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100525420","phase-2-phase-ii-trial-low-dose-radiation--sbrt--sintilimab--chemotherapy-vs-sintilimab--chemotherapy-in-locally-advanced-or-metastatic-squamous-cell-lung-cancer-100525420","NCT06121505","Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer","Low-dose Radiation Therapy and Stereotactic Body Radiation Therapy Combined With PD-1 Inhibitor Sintilimab and Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Patients With Locally Advanced or Metastatic Squamous Cell Lung Cancer: A Randomized, Phase II Multicenter Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 75 years old;\n2. Histologically or cytologically confirmed squamous cell lung cancer, imaging confirmed locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV);\n3. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one imaging measurable lesion;\n4. Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression;\n5. Have not received any systemic anti-tumor treatment for locally advanced or metastatic disease in the past;\n\nExclusion Criteria:\n\n1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；\n2. The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma and lung squamous cell carcinoma;\n3. EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;\n4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;\n5. Pregnant or lactating women;",{"count":185,"type":22},114,[26],"This is a randomized, controlled, open-label, multicenter phase II clinical trial comparing the efficacy and safety of low-dose radiation therapy and stereotactic body radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic squamous cell lung cancer.\n\nThere will be 57 subjects in the experimental group and 57 subjects in the control group, with a total of 114 subjects.",[32],[190,191,192,32],"SBRT","Immunotherapy","LDRT","2025-12-09",{"date":195,"type":50},"2025-12-17",{"date":197,"type":50},"2024-03-01",{"date":199,"type":22},"2027-02-28",{"name":201,"class":88},"Sichuan University",6,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":211,"conditions":212,"keywords":216,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":89},"100535697","characteristics-treatment-patterns-and-outcomes-for-patients-with-surgically-resected-lung-cancers-100535697","NCT06255197","Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers","Inclusion Criteria:\n\n* Age above 18.\n* Have received surgical resection for lung malignancies.\n\nExclusion Criteria:\n\n* Participants whose data are of low quality, poor completeness or poor internal linkage.",{"count":210,"type":22},60000,"This study is a multi-center, observational, real-world study for patients with resected lung cancers in China. With the help of a properly designed data processing algorithm and extensively performed data quality assurance, this study aims to harness the potential of real-world big data to (1) describe characteristics and treatment patterns and their evolving trends; (2) discover features associated with overall survival; and (3) address recently-emerging clinical questions.",[213,30,32,214,215],"Lung Cancer","Non Small Cell Lung Cancer","Small-cell Lung Cancer",[217,218,219],"Lung cancer","Surgery","Real world","2024-02-14",{"date":222,"type":50},"2024-02-16",{"date":224,"type":50},"2019-11-04",{"date":226,"type":22},"2031-12-31",{"name":228,"class":88},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":66,"enrollmentInfo":236,"targetDuration":4,"studyType":131,"phases":4,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":89},"100499053","the-role-of-ctdna-testing-plus-ai-based-pathology-in-resectable-lscc-100499053","NCT05778253","The Role of ctDNA Testing Plus AI-based Pathology in Resectable LSCC","Circulating Tumor DNA (ctDNA) Dynamic Monitoring Plus Artificial Intelligence (AI)-Based Pathology Predict the Efficacy of Chemoimmunotherapy in Resectable Lung Squamous Cell Carcinoma (LSCC)","Inclusion Criteria:\n\n* Histopathology or cytology confirmed the lung squamous cell carcinoma\n* Age ranging from 18 to 75\n* Agree to participate in this study and sign an informed consent form\n* Treatment-naive tumor\n* According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage II-IIIb resectable or potentially resectable tumor\n* Sufficient tissue\u002Fblood samples are available to meet research requirements\n* The ECOG PS score is 0-1\n\nExclusion Criteria:\n\n* Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form\n* Non-squamous NSCLC\n* Unresectable IIIa-IIIb tumor\n* Patients with solid organ or blood system transplantation\n* Previous use of CTLA-4, PD-1, or PD-L1 immune checkpoint inhibitors\n* Patients with interstitial lung disease\n* Patients with acute or chronic infectious disease\n* Pregnant and lactating women\n* Patients who have undergone other clinical drug trials",{"count":237,"type":22},50,"The goal of this observational study is to explore whether ctDNA dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment.",[32],"2023-03-18",{"date":242,"type":50},"2023-03-21",{"date":244,"type":22},"2023-03-23",{"date":246,"type":22},"2029-09-23",{"name":248,"class":88},"Second Xiangya Hospital of Central South University"]