[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"adenosquamous-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:adenosquamous-carcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100219375","phase-2-t-cell-receptor-immunotherapy-for-patients-with-metastatic-non-small-cell-lung-cancer-100219375",false,"NCT02133196","T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer","A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen","* INCLUSION CRITERIA:\n\n  1. Measurable metastatic (stage IV) or unresectable non-small cell lung cancer (including but not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas) with at least one lesion that is resectable for TIL generation. (Note: neuroendocrine tumors are not eligible.)\n  2. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n  3. All patients must have had at least one appropriate first line systemic therapy and progressed.\n  4. Clinical performance status of ECOG 0 or 1.\n  5. Age \\>= 18 years of age and \\\u003C= 72 years of age.\n  6. Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for individuals of childbearing potential (IOCBP) and for four months after treatment for individuals able to father a child.\n  7. Willing to sign a durable power of attorney\n  8. Able to understand and sign the Informed Consent Document\n\nI. Hematology:\n\n* Absolute neutrophil count \\> 1000\u002Fmm\\^3 without support of filgrastim\n* Normal WBC (\\>= 2500\u002Fmm\\^3).\n* Hemoglobin \\> 8.0 g\u002Fdl. Subjects may be transfused to reach this cut-off.\n* Platelet count \\>= 80,000\u002Fmm\\^3\n\n  j. Serology:\n* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\n  k. Chemistry:\n* Serum ALT\u002FAST \\\u003C= 2.5 times the upper limit of normal.\n* Serum creatinine \\\u003C= 1.6 mg\u002Fdl.\n* Total bilirubin \\\u003C= 2 mg\u002Fdl, except in patients with Gilbert's Syndrome, who must have a total bilirubin \\\u003C= 3 mg\u002Fdl.\n\n  l. IOCBP must have a negative pregnancy test or evidence that they are not pregnant (e.g., ultrasound or serial HCG measurements) prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\n  m. Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or local radiotherapy within the past 4 weeks, as long as related major organ toxicities have recovered to grade 1 or less.\n\nn. More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient's toxicities must have recovered to a grade 1 or less.\n\no. Subjects must be co-enrolled in protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n1. Participants who are nursing because of the potentially dangerous effects of the treatment on the infant.\n2. Ongoing need for pharmacological immunosuppression, including steroids\n3. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses\n4. Major bronchial occlusion or bleeding not amenable to palliation.\n5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency\n\n   Disease and AIDS).\n6. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n8. For select patients with a clinical history prompting cardiac evaluation: last known LVEF \\\u003C= 45%.\n9. For select patients with a clinical history prompting pulmonary evaluation: known FEV1 \\\u003C= 50%\n10. Any of the following will exclude patients from the high-dose aldesleukin arm, but may be eligible for the low-dose aldesleukin arm:\n\n    * Greater than 2 invasive thoracic procedures\n    * Poor exercise tolerance\n    * Greater than 66 years of age\n    * Clinically significant patient history which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate high-dose.\n11. Patients who are receiving any other investigational agents.","ALL","18 Years","72 Years",{"count":20,"type":21},85,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nThe NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 100 patients. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells.\n\nObjective:\n\nThe purpose of this study is to see if these specifically selected tumor fighting cells can cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is safe.\n\nEligibility:\n\n\\- Adults age 18-72 with NSCLC who have a tumor that can be safely removed.\n\nDesign:\n\n* Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed\n* Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product.\n* Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.}\n* Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment.\n\nFollow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.",[27,28,29,30,31],"Advanced Non-Small Cell Lung Cancer","Squamous Cell Carcinoma","Advanced NSCLC","Adenosquamous Carcinoma","Adenocarcinoma",[33,34,35,36],"Metastatic","Non-Small Cell Lung Cancer","NSCLC","Lung Cancer","RECRUITING","2026-06-05",{"date":40,"type":41},"2026-06-08","ACTUAL",{"date":43,"type":41},"2014-10-23",{"date":45,"type":21},"2027-10-23",{"name":47,"class":48},"National Cancer Institute (NCI)","NIH",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100483906","phase-3-para-aortic-lymphadenectomy-in-locally-advanced-cervical-cancer-100483906","NCT05581121","PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer","PAROLA","Inclusion Criteria:\n\n1. Age ≥ 18 years at time of study entry\n2. Newly diagnosed histologically proven cervical squamous carcinoma, adenocarcinoma, or adenosquamous tumor\n3. FIGO stage IIIC1 (FIGO 2018) cervical cancer with FDG-PET\u002FCT showing FDG-positive pelvic nodes and FDG-negative PALN including equivocal lymph nodes in the common iliac and para-aortic regions. The highest positive lymph node must be located inferior to the common iliac bifurcation in both sides (anatomical level 1).\n4. Patients with TNM T stage I-IIIB.\n5. FIGO stage IIIC1 cervical cancer by positive pelvic sentinel lymph node from surgical staging (either intraoperative assessment (frozen section) or from final histology - patients are not eligible after radical hysterectomy, and FDG-negative common iliac of para-aortic lymph node on PET\u002FCT (performed before or after SLN procedure)\n6. Patient eligible for pelvic radiotherapy and cisplatin-based chemotherapy with a curative intent as confirmed by a multidisciplinary board\n7. ECOG performance status \\\u003C 2 i.e. 0 or 1\n8. Life expectancy more than 12 months\n9. Pretherapeutic imaging FDG-PET\u002FCT images should be available for central review\n10. Prior validation of the surgeon's participation in the study by the Quality Assurance Comity\n11. Women should be post-menopaused or willing to accept the use of an effective contraceptive regimen during the treatment period. All non-menopaused women should have a negative pregnancy test within 72 hours prior to study entry.\n12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n13. Not applicable since protocol revision V4. Patient participating to other clinical trials including immunotherapy strategies or adjuvant chemotherapy is also eligible for the study. Adjuvant treatment must be decided prior to randomization\n14. Signed informed consent\n15. Patient affiliated to a Social Health Insurance in France (French patients only).\n\nExclusion Criteria:\n\n1. Unequivocal positive common iliac or para-aortic lymph nodes at pretherapeutic imaging FDG-PET\u002FCT\n2. Negative or equivocal pelvic lymph nodes at pretherapeutic imaging FDG-PET\u002FCT\n3. Metastatic disease confirmed by FDG-PET\u002FCT\n4. Other histologies than adenocarcinoma, squamous cell carcinoma and adenosquamous carcinoma\n5. Contraindication for cisplatin-based chemotherapy\n6. Women who received any prior treatment for cervical cancer\n7. Prior surgery for the cervical cancer, except for cone procedure and pelvic lymph node staging\n8. Previous pelvic radiotherapy\n9. History of another primary malignancy except for: Malignancy treated with curative intent and with no known active disease after 5 years, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ (any location) without evidence of disease.\n10. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure\n11. Patient who has forfeited his\u002Fher freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).","FEMALE",{"count":59,"type":21},510,[61],"PHASE3","This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET\u002FCT only followed by chemoradiation.\n\nThe planned sample size is 510; including 200 patients in France.\n\nIn this trial, patients will be assigned in one of the two following treatments arms:\n\n* Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO\u002FESTRO recommendations.\n* Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy.\n\nConsidering the changing standard treatment landscape of locally advanced cervical cancer, both arms (control arm and experimental arm) may also be treated according to the INTERLACE and KEYNOTE-A18 studies, if applicable, at the discretion of the attending physician.\n\nEach patient will be followed up for 5 years.\n\nA cost-utility study will be performed in patients included in France. Other countries could be involved in this specific study. It will assess the incremental cost-utility ratio (cost per QALY gained) of para-aortic lymphadenectomy followed by tailored chemo-radiation in patients with positive PALN compared to patients staged with PET\u002FCT only followed by chemo-radiation.\n\nThis study also has ancillary objectives:\n\n* Biologic: To study T cell exhaustion, immune changes during chemoradiation, HPV ctDNA dynamic evolution, and the par-aortic lymph node as a premetastatic niche.\n* Radiomics: To study the contribution of radiomics and FDG-PET\u002FCT metabolic parameters to predict para-aortic lymph node involvement and clinical outcome.\n* Senti-PAROLA: To evaluate the accuracy (Sensitivity, specificity, positive and negative predictive value) of the para-aortic sentinel lymph node (SPA) for PALN staging, and to evaluate the prognostic value of low volume metastasis of SPA.",[64,31,30],"Cervical Carcinoma",[66,67,68,69,70,71,72,73],"Locally advanced cervical cancer","HPV 16+","Stage IIIC1","Radiation therapy","Cisplatin","Para-aortic lymphadenectomy","INTERLACE","KEYNOTE-A18","2026-05-21",{"date":76,"type":41},"2026-05-26",{"date":78,"type":41},"2023-12-20",{"date":80,"type":21},"2033-12-20",{"name":82,"class":83},"Institut Claudius Regaud","OTHER",35]