[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-malignant-neoplasm-in-the-lung\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-malignant-neoplasm-in-the-lung":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,72,100,120,145,167],{"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":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100500894","stereotactic-body-radiation-therapy-planning-with-artificial-intelligence-directed-dose-recommendation-for-treatment-of-primary-or-metastatic-lung-tumors-rad-ai-study-100500894",false,"NCT05802186","Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study","A Single-Arm Phase II Study of Personalized Dose Guidance for Stereotactic Body Radiotherapy (SBRT) in Patients With Lung Tumors","Inclusion Criteria:\n\n* Patients with radiographic findings consistent with lung cancer or solitary or oligometastatic disease in the lung. Most patients will have primary non-small cell lung cancer. For primary lung cancers, we include lesions with ground glass opacities with a solid component of 50% or greater. Patients with solitary or oligo-metastatic disease in the lung may have any other histology or cancer type.\n* Patients must have radiographically measurable or evaluable disease per RECIST v. 1.1.\n* Patients must be age \\>= 18 years.\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patients of child-bearing potential (POCBP) must have a negative urine or serum pregnancy test prior to registration on study.\n\n  * NOTE: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n    * Has not undergone a hysterectomy or bilateral oophorectomy\n    * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months)\n* Radiation therapy is known to be teratogenic. Patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent, for the duration of study participation, and for 7 days following completion of therapy. Should a patient become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. People who can impregnate their partners treated or enrolled on this protocol must also agree to use adequate contraception from time of informed consent, for the duration of study participation, and 90 days after completion of administration.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document. Informed consent must be signed prior to registration on study.\n\nExclusion Criteria:\n\n* Patients who have had prior radiotherapy with radiation field overlap.\n* For primary lung cancers, patients with ground glass opacities without a solid component will be excluded.\n* Patients who have not recovered from adverse events confined to the thorax (i.e. pneumonitis, bronchial insufficiency, bronchial hemorrhage, esophagitis) due to prior anticancer therapy (i.e., have residual toxicities \\>= grade 2) with the exception of alopecia. low blood counts (neutropenia, anemia, etc), or anatomically distinct toxicities (i.e. cystitis).\n* Patients who are receiving any other concurrent investigational agents or genotoxic chemotherapy for cancer treatment.\n\n  * Note: Patients receiving targeted therapies are permitted to enroll on the study. However, patients must pause treatment with targeted therapy 3 days prior to SBRT and restart medication at least 2 days after SBRT. Concurrent immunotherapy (if not investigational) is permitted. Coronavirus disease 2019 (COVID-19) vaccinations are allowed.\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:\n\n  * Ongoing or active infection requiring systemic treatment\n  * Unstable angina pectoris\n  * Stage 3 or greater idiopathic pulmonary fibrosis\n  * Cardiac arrhythmia\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n* Female patients who are pregnant or nursing. Pregnant women are excluded from this study because radiation therapy has teratogenic or abortifacient effects.","ALL","18 Years",{"count":19,"type":20},70,"ESTIMATED","INTERVENTIONAL",[23],"NA","This phase II trial tests the effectiveness and safety of artificial intelligence (AI) to determine dose recommendation during stereotactic body radiation therapy (SBRT) planning in patients with primary lung cancer or tumors that has spread from another primary site to the lung (metastatic). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Even with the high precision of SBRT, disease persistence or reappearance (local recurrence) can still occur, which could be attributed to the radiation dose. AI has been used in other areas of healthcare to automate and improve various aspects of medical science. Because the relationship of dose and local recurrence indicates that dose prescriptions matter, decision support systems to help guide dose based on personalized prediction AI algorithms could better assist providers in prescribing the radiation dose of lung stereotactic body radiation therapy treatment.",[26,27,28,29,30,31],"Lung Carcinoma","Lung Non-Small Cell Carcinoma","Metastatic Malignant Neoplasm in the Lung","Stage I Lung Cancer AJCC v8","Stage II Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","RECRUITING","2026-05-26",{"date":35,"type":36},"2026-05-29","ACTUAL",{"date":38,"type":36},"2023-11-20",{"date":40,"type":20},"2031-08-01",{"name":42,"class":43},"Northwestern University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100457328","phase-3-thoracotomy-versus-thoracoscopic-management-of-pulmonary-metastases-in-patients-with-osteosarcoma-100457328","NCT05235165","Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma","A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma","Inclusion Criteria:\n\n* Patients must be \\\u003C 50 years at the time of enrollment.\n* Patients must have =\\\u003C 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being \\>= 3 mm and all of which must be =\\\u003C 3 cm size.\n\n  * Note: Patient must have eligibility confirmed by rapid central imaging review.\n* Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon.\n* Patients must have a histological diagnosis of osteosarcoma.\n* Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.\n* Patients with newly diagnosed disease must have completed successful gross tumor resection for their primary tumor or surgical local control of primary tumor must be planned to be performed simultaneously with thoracic surgery.\n* Newly diagnosed patients must be receiving or recently completed (within 60 days) systemic therapy considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.\n* Patients at time of 1st recurrence must have completed systemic therapy for their initial primary tumor, considered by the treating physician to be standard treatment for newly diagnosed osteosarcoma (eg, cisplatin-doxorubicin or ifosfamide-based drug regimens) at the time of enrollment on this study. Dose and drug modifications for toxicity do not exclude patients from participation.\n\nExclusion Criteria:\n\n* Patients with unresectable primary tumor.\n* Patients with pulmonary metastatic lesions that would require anatomic resection (lobectomy or pneumonectomy) or lesions that are defined as \"central\" (i.e., central lesion involves or is proximal to segmental bronchi and peripheral is lesion distal to segmental bronchi).\n* Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.\n* Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. Note: Once the patient has been enrolled on the study, additional computed tomography (CT) scans are not anticipated prior to thoracic surgery. Note: Some variation in nodule size measurements over the course of pre-operative therapy is anticipated and does not qualify for exclusion unless deemed true disease progression by the primary treatment team.\n* Patients with evidence of extrapulmonary metastatic disease.\n* Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment.\n* All patients and\u002For their parents or legal guardians must sign a written informed consent.\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.","50 Years",{"count":54,"type":20},62,[56],"PHASE3","This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.",[28,59,60],"Metastatic Osteosarcoma","Osteosarcoma","2026-05-01",{"date":63,"type":36},"2026-05-05",{"date":65,"type":36},"2022-04-01",{"date":67,"type":20},"2031-03-31",{"name":69,"class":70},"Children's Oncology Group","NETWORK",232,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":44},"100359833","phase-1-pulmonary-suffusion-in-controlling-minimal-residual-disease-in-patients-with-sarcoma-or-colorectal-metastases-100359833","NCT03965234","Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases","Phase I\u002F II Study of Pulmonary Suffusion to Control Minimal Residual Disease in Resectable or Ablatable Sarcoma or Colorectal Pulmonary Metastases","Inclusion Criteria:\n\n* Tumors metastatic to the lungs that are the focus of this protocol specifically:\n\n  * Soft tissue sarcoma\n  * Osteosarcoma\n  * Colorectal carcinoma\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* Hemoglobin \\> 8.0 g\u002FL\n* Granulocytes \\> 1,500 uL\n* Platelets \\>= 100,000 uL\n* Creatinine clearance \\>= 30 mL\u002Fmin\n* Clinically diagnosed resectable sarcoma lung metastases(while preregistration histologic or cytologic confirmation is desirable, this may not be required in clinical scenarios where a biopsy may not change the need to resect suspicious lung nodules or the biopsy itself poses a risk for tumor seeding. In such cases, the diagnosis will be supported by rapid pathologic evaluations intraoperatively before proceeding with Suffusion) Given the emergence of other acceptable options to destroy lung metastases such as SBRT or microwave ablation, a hybrid approach to eliminate all sites of disease will be permitted; however, supplemental approaches should be delayed, if possible, until after the 30 day post-suffusion endpoint\n* Forced expiratory volume in 1 second (FEV1) \\>= 50% predicted\n* Diffusion capacity of the lung for carbon monoxide (DLCO) \\>= 50% predicted\n* Vital capacity (VC) \\>= 50% predicted\n* Ambulatory and resting oxygen (O2) saturation \\> 88%\n* Six minute walk \\>= 50 % of the expected distance\n* Surgeon affirmation that suffusion is technically feasible\n* Borg Dyspnea scale (modified) \\\u003C 5\n* Control of the primary tumor as determined by clinical assessment per standard of care; may include stable tumor status of primary tumor and other metastases, in the clinical judgement of the PI\u002FPhysician.\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\n* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events\n* Allergy, intolerance, or other serious reaction to chemotherapy drugs that may be used in the procedure\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Pulmonary metastases unable to be completely resected or ablated based on pre-registration review of imaging by a thoracic surgeon or proceduralist.\n* Any additional condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug or the suffusion technique, may include uncontrolled intercurrent illness and other conditions that, in the judgement of the PI\u002FPhysician, would limit compliance with the study requirements and have safety concerns\n* Received an investigational agent within 30 days prior to enrollment\n* Severe peripheral neuropathy",{"count":80,"type":20},99,[82,83],"PHASE1","PHASE2","This phase I\u002FII trial studies the side effects of pulmonary suffusion in controlling minimal residual disease in patients with sarcoma or colorectal carcinoma that has spread to the lungs. Pulmonary suffusion is a minimally invasive delivery of chemotherapeutic agents like cisplatin to lung tissues. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pulmonary suffusion may also be useful in avoiding later use of drugs by vein that demonstrate no effect on tumors when delivered locally.",[86,28,87,88,89,90],"Metastatic Bone Sarcoma","Metastatic Soft Tissue Sarcoma","Metastatic Unresectable Sarcoma","Resectable Sarcoma","Colorectal Cancer","2026-03-13",{"date":93,"type":36},"2026-03-17",{"date":95,"type":36},"2020-07-16",{"date":97,"type":20},"2030-05-25",{"name":99,"class":43},"Roswell Park Cancer Institute",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":44},"100553129","molecular-analysis-of-suspected-or-high-risk-lung-cancer-to-drive-individualized-care-interception-for-suspected-lung-cancer-100553129","NCT06482073","Molecular Analysis of Suspected or High-Risk Lung Cancer to Drive Individualized Care (Interception for Suspected Lung Cancer)","Inclusion Criteria:\n\n* Subject age 18 years and older\n* Subject is scheduled\u002Fwas scheduled for a bronchoscopy as part of standard of care\n* Subject with a moderate to high risk of lung cancer based on clinical demographic and radiologic information or with suspected metastatic disease\n* Ability to provide blood or saliva sample\n* Ability to provide archived tissue\n* Subject is able to understand and adhere to study requirements and able to provide informed consent\n\nExclusion Criteria:\n\n* Individuals who have situations that would limit compliance with the study requirements\n* Institutionalized (i.e. federal medical prison)\n* Pregnant\n* Prior germline genetic testing with a 40+ multi-gene panel within the last 1 year of enrollment\n* Prior somatic tissue (250+ gene) testing within the prior 3 months of enrollment",{"count":107,"type":20},40,"OBSERVATIONAL","This study evaluates the effectiveness of robotic biopsies in providing information about hereditary or cancer specific genetic variants that may have a role in diagnosis of cancer and to develop genetic results and medical record databank for future studies.",[26,28],"2026-02-24",{"date":113,"type":36},"2026-02-27",{"date":115,"type":36},"2024-06-24",{"date":117,"type":20},"2027-07-01",{"name":119,"class":43},"Mayo Clinic",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":16,"minAge":127,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":44},"100330429","phase-1-panitumumab-irdye800-in-detecting-cancer-in-participants-with-lung-cancer-during-surgery-100330429","NCT03582124","Panitumumab-IRDye800 in Detecting Cancer in Participants With Lung Cancer During Surgery","A Phase I\u002FII Study Evaluating the Safety and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Lung Cancer During Surgical Procedures","Inclusion Criteria:\n\n* Patients with lung nodule or mass concerning for malignancy, either primary lung cancer or lung metastases, whether or not it is biopsy-proven\n* Patients scheduled to undergo planned standard of care surgical resection for a lung nodule or mass with diagnostic and\u002For curative intent for lung cancer\n* Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)\u002FZubrod level 0-2\n* Hemoglobin ≥ 9 gm\u002FdL\n* White blood cell count \\> 3000\u002Fmm\\^3\n* Platelet count ≥ 100,000\u002Fmm\\^3\n* Serum creatinine ≤ 1.5 times upper reference range\n\nExclusion Criteria:\n\n* Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800\n* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment\n* History of infusion reactions to monoclonal antibody therapies\n* Pregnant or breastfeeding\n* Magnesium or potassium lower than the normal institutional values\n* Subjects receiving class IA (quinidine, procanamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents\n* Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis\n* Prisoners, institutionalized individuals, and patients unable to consent for themselves","19 Years",{"count":129,"type":20},30,[82,83],"This phase I\u002FII trial studies the best dose and timing of panitumumab-IRDye800 in detecting cancer in participants with lung cancer during the surgery. Panitumumab-IRDye800 is a combination of the antibody drug panitumumab and IRDye800CW, an investigational dye that can be seen using a special camera. Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with lung cancer.",[26,28,133,134,135],"Stage IV Lung Cancer AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8","2026-02-07",{"date":138,"type":36},"2026-02-10",{"date":140,"type":36},"2018-07-19",{"date":142,"type":20},"2026-09",{"name":144,"class":43},"Stanford University",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":44},"100442303","phase-1-phase-iii-randomized-study-of-nbtxr3-activated-by-abscopal-or-radscopal-radiation-in-combination-with-immunotherapy-anti-pd-1l-1-for-patients-with-advanced-solid-malignancies-100442303","NCT05039632","Phase I\u002FII Randomized Study of NBTXR3 Activated by Abscopal or RadScopal Radiation in Combination With Immunotherapy (Anti-PD-1\u002FL-1) for Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Patients with metastatic disease in the lung and\u002For liver, or soft tissue from any primary malignancy considered incurable by local therapies.\n\n   a. One prior anti-PD-1\u002FL1 therapy allowed.\n2. The target lesion(s) must be measurable as per irRECIST and repeated measurements at the same anatomical location should be achievable.\n\n   a. Participant must have at least 2 measurable lesions at screening. i. Abscopal cohort: At least one lesion will receive NBTXR3 and high dose radiation (high dose target lesion). The other lesion(s) (non-treated target lesion) will be followed for response and it will not receive NBTXR3 or RT.\n\n   ii. RadScopal™ cohort: At least one lesion will receive NBTXR3 and high dose radiation (high dose target lesion). The other lesion(s) will only receive low dose radiation (low dose target lesion).\n3. Amenable to undergo the image guided (EBUS or CT or MRI) intratumoral injection of NBTXR3, in up to two (2) high dose target lesions, as determined by the investigator or treating physician at screening.\n\n   a. Intratumoral NBTXR3 injections only allowed in lung or liver lesions.\n4. Selected high and low dose target lesions must be amenable to receive radiation therapy as determined by the investigator or treating radiation oncologist.\n\n   1. Allowed high dose RT regimens are 50 Gy in 4 fractions or 60 Gy in 10 fractions\n   2. Allowed low dose RT for RadScopal™ cohort is 1.4 Gy per fraction for 4 - 5 fractions to only low dose-target lesion(s) determined by the investigator or treating physician.\n5. Patients can receive radiation therapy for symptomatic metastatic disease prior to enrollment or during the study a.\n6. Age ≥ 18 years\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n8. Laboratory Values at screening:\n\n   1. Hemoglobin ≥ 9.0 g\u002FdL\n   2. Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3\n   3. Platelet count ≥ 100,000\u002Fmm3\n   4. Leukocytes ≥ 1500\u002Fmm3\n   5. Creatinine ≤ 1.5 x upper limit of normal (ULN)\n   6. Calc. creatinine clearance \\> 30mL\u002Fmin\n   7. Total bilirubin ≤ 2.0 mg\u002FdL\n   8. AST \u002F ALT ≤ 2.0 x upper limit of normal (ULN) or ≤ 3 x ULN for patients with liver metastases\n9. For participants to be treated for lung metastases, adequate lung function with expiratory volume in 1 second (FEV1) ≥ 0.8L or ≥ 35% predicted and carbon monoxide diffusing capability (DLCO) ≥ 40% with or without bronchodilator within 30 days prior to NBTXR3 injection. Participants to be treated for liver metastasis a pulmonary function test is not required.\n10. Patients who meet the criterion above without oxygen (02), but need acute (started within 7 ± 3 days) supplemental oxygen due to tumor-caused obstruction\u002Fhypoxia are eligible, provided the amount of the O2 needed has been stable.\n11. Negative urine or serum pregnancy test ≤ 7 days prior to NBTXR3 injection in all women of child-bearing potential (WOCBP). WOCBP must agree to follow instructions for method(s) of contraception for the duration the entire study period and 160 days (\\~5.33 months) after the last dose of anti-PD-1\u002FL-1 treatment. Local laws and regulations may require use of alternative and\u002For additional contraception methods. WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements but should still undergo pregnancy testing.\n12. Signed informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.\n\n4.2 Exclusion criteria:\n\n1. Prior radiation therapy received to the selected high dose target lesion(s)\n\n   a. Previous radiation to low dose target lesions allowed as per investigator or treating radiation oncologist discretion.\n2. Symptomatic central nervous system metastases and\u002For carcinomatous meningitis\n\n   a. Participants with previously treated brain metastases may participate if those lesions are radiologically stable (i.e., without evidence of progression for at least 4 weeks by repeat imaging at screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to NBTXR3 injection.\n3. At screening, past medical history of:\n\n   1. Interstitial lung disease\n   2. Unresolved organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia)\n   3. Any Grade 4 radiation toxicity\n   4. Unresolved, radiation or ICI related\n\n   i. Pneumonitis ii. Bronchopulmonary hemorrhage iii. Abdominal hemorrhage e. Unresolved GI related events i. Diverticulitis ii. Colitis iii. Intra-abdominal abscess iv. GI obstructions v. Abdominal carcinomatosis vi. Any known risk factor for bowel perforation\n4. History of severe (Grade ≥ 3) immune-related adverse events observed with previous immunotherapy (anti-PD-1\u002FL1) or known sensitivity (Grade ≥ 3) to any excipients.\n5. Has received any approved or investigational anti-neoplastic agent or immunotherapy within 2 weeks prior to NBTXR3 injection.\n\n   1. Except anti-PD-1\u002FL1, which will not require a washout window.\n   2. A reduced washout window may be considered for therapies with short half-lives (i.e., kinase inhibitors) after discussion with Nanobiotix and investigator.\n6. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).\n\n   a. Replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement \\[≤ 10 mg prednisone\\] therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n7. Any live-virus vaccine used for prevention of infectious diseases administered within 4 weeks prior to NBTXR3 injection.\n\n   1. Except killed-virus Influenza vaccine\n   2. Exception of other vaccines (e.g. pneumonia) is at the discretion of the treating physician after conducting a personalized risk assessment on a case by case basis.\n8. Prior allogenic stem cell transplantation or organ allograft.\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, renal failure, cardiac arrhythmia, or psychiatric illness that would limit compliance with treatment.\n10. Known active, uncontrolled (high viral load) HIV or hepatitis B or hepatitis C infection.\n11. Female patients who are pregnant or breastfeeding.\n12. Women of child-bearing potential and their male partners who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and up to 160 days (\\~5.33 months) for female participants, and 7 months for males participants or female partners of male participants that are of child-bearing potential, after the last dose of anti-PD-1\u002FL-1.\n\n    a. Acceptable methods of contraception are those that, alone or in combination, result in a failure rate of \\\u003C 1% per year when used consistently and correctly.\n13. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.",{"count":107,"type":20},[82,83],"This phase I\u002FII trial studies the side effects and possible benefits of NBTXR3, radiation therapy, Anti PD-1 \u002F PD-L1 in treating patients with solid tumor that has spread to the lung (lung metastases) and\u002For liver (liver metastases). NBTXR3 may help make tumor cells more sensitive to the radiation therapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with Anti PD-1 \u002F PD-L1 monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3, radiation therapy, Anti PD-1 \u002F PD-L1 may help to control the disease.",[155,156,28,157],"Advanced Malignant Solid Neoplasm","Metastatic Malignant Neoplasm in the Liver","Metastatic Malignant Solid Neoplasm","2026-02-04",{"date":160,"type":36},"2026-02-06",{"date":162,"type":36},"2023-05-08",{"date":164,"type":20},"2028-02-01",{"name":166,"class":43},"M.D. Anderson Cancer Center",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":44},"100318174","continuous-positive-airway-pressure-device-or-deep-inspiration-breath-hold-in-reducing-tumor-motion-in-patients-undergoing-stereotactic-body-radiation-therapy-for-lung-cancer-100318174","NCT03422302","Continuous Positive Airway Pressure Device or Deep Inspiration Breath Hold in Reducing Tumor Motion in Patients Undergoing Stereotactic Body Radiation Therapy for Lung Cancer","Measuring the Effectiveness of a Continuous Positive Airway Pressure (CPAP) Device to Reduce Tumor Motion and Increase Lung Volume Expansion in Patients Undergoing Stereotactic Body Radiotherapy (SBRT) for Tumors That Move With Respiration","Inclusion Criteria:\n\n* The patient will receive stereotactic body radiotherapy in the Thoracic Radiation Oncolcogy Service at MD Anderson.\n\nExclusion Criteria:\n\n* The patient has a contra-indication for using a CPAP device.\n* The patient has not signed a study-specific informed consent for this study.\n* The patient is uncooperative.\n* The patient has reduced consciousness.\n* The patient has sustained trauma or burns to the face.\n* The patient has undergone any facial, esophageal, gastric or sinus surgery within the last 3 months.\n* The patient has idiopathic pulmonary fibrosis (IPF) as documented in their medical history.\n* Adults who are unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study.",{"count":129,"type":20},[23],"This pilot phase I\u002FII trial studies how well a continuous positive airway pressure device or deep inspiration breath hold works in reducing tumor movement in patients undergoing stereotactic body radiation therapy (SBRT) for lung cancer. The continuous positive airway pressure device works by blowing air into the lungs while patients wear a face mask or nozzle to help expand their airways and lungs. Deep inspiration breath hold is a standard technique that uses active breath-holding to restrict movement of the body. Using a continuous positive airway pressure device may work better than deep inspiration breath hold in lowering the amount of tumor movement during stereotactic radiation body therapy.",[26,178,28],"Malignant Respiratory Tract Neoplasm","2026-01-23",{"date":181,"type":36},"2026-01-27",{"date":183,"type":36},"2018-03-16",{"date":185,"type":20},"2028-05-31",{"name":166,"class":43}]