[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nsclc-stage-iiib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nsclc-stage-iiib":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,65],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100460882","phase-2-additional-chemotherapy-for-egfrm-patients-with-the-continued-presence-of-plasma-ctdna-egfrm-at-week-3-after-start-of-osimertinib-1st-line-treatment-pace-lung-100460882",false,"NCT05281406","Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)","Inclusion Criteria:\n\nPre-Screening Phase\n\n1. Provision of written informed consent for the pre-screening phase.\n2. Age ≥ 18 years\n3. Histologically confirmed stage IIIB or IV NSCLC\n4. Tumor positive for Ex19del or L858R EGFR mutation assessed according to local standard.\n5. Planned treatment with osimertinib 80mg\u002Fd 1st-line as SoC or ongoing treatment for a maximum of 28 days\n6. Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial osimertinib treatment\n7. Previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease, except for osimertinib for a maximum of 28 days (see above)\n8. At least one measurable site of disease as defined by RECISTv1.1 criteria\n9. Female subjects of childbearing potential (WOCBP) should be using highly effective contraceptive measures and must have a negative urine or serum pregnancy test within 7 days prior to start of study treatment and must not be breast-feeding prior to start of trial. Further information in Appendix 20.7 (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods)\n10. Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening:\n\n    * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n    * Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.\n    * Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation\n\nTreatment Phase\n\n1. Provision of informed consent for the screening and treatment phase prior to any study specific procedures, including screening evaluations that are not SoC.\n2. Persistent mEGFR ctDNA signal 21 to 28 days after osimertinib initiation for advanced of metastatic ex19del or L858R EGFR mutation positive NSCLC as assessed by a liquid biopsy during the pre-screening phase of the trial in the central laboratory.\n3. ECOG performance status 0-2.\n4. The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.\n5. Osimertinib no longer than 10 weeks before start of chemotherapy in the treatment phase\n\nExclusion Criteria:\n\nPre-Screening Phase\n\n1. History of another primary malignancy. Exceptions are:\n\n   * Malignancy treated with curative intent and with no known active disease ≥6 months before the first dose of IMP, and of 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\n2. History of leptomeningeal carcinomatosis\n3. 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\n4. Previous enrolment in the present study.\n\nTreatment Phase\n\n1. Symptomatic CNS metastases. \\[Patients with asymptomatic brain metastases may be included.\\]\n2. History of leptomeningeal carcinomatosis\n3. Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior) (Appendix 20.5). All patients must try to avoid concomitant use of any medications, herbal supplements and\u002For ingestion of foods with known inducer effects on CYP3A4.\n4. Osimertinib had to be withheld or administered at reduced dosage for toxicity management for more than 7 days or persistent unresolved toxicities which preclude study treatment.\n5. Any unresolved toxicities other than osimertinib from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 prior platinum-therapy-related neuropathy.\n6. History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib. History of hypersensitivity to any of the chemotherapy drugs used.\n7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n8. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.\n9. Any of the following cardiac criteria:\n\n   1. Mean resting corrected QT interval (QTc) \\> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value\n   2. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block.\n   3. Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum\u002Fplasma potassium \\\u003C LLN; Serum\u002Fplasma magnesium \\\u003C LLN; Serum\u002Fplasma calcium \\\u003C LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes. \\[Note: Electrolyte abnormalities (hypokalaemia, hypomagnesaemia, hypocalcaemia) can be corrected to be within normal ranges prior to first dose. No more than two re-tests may be performed in order to meet this criterion.\\]\n10. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n11. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n    1. Absolute neutrophil count below lower limit of normal (\\\u003CLLN) \\*\n    2. Platelet count below lower limit of normal (\\\u003CLLN) \\*\n    3. Hemoglobin \\\u003C90 g\u002FL \\*\n\n       \\* The use of granulocyte colony stimulating factor support, platelet transfusion and blood transfusions to meet these criteria is not permitted.\n    4. Alanine aminotransferase \\>2.5 times ULN if no demonstrable liver metastases or \\>5 times ULN in the presence of liver metastases;\n    5. Aspartate aminotransferase \\>2.5 times ULN if no demonstrable liver metastases or \\>5 times ULN in the presence of liver metastases;\n    6. Total bilirubin \\>1.5 times ULN if no liver metastases or \\>3 times ULN in the presence of documented Gilbert's Syndrome \\[unconjugated hyperbilirubinaemia\\] or liver metastases;\n    7. Serum creatinine \\>1.5 times ULN concurrent with creatinine clearance \\\u003C60 mL\u002Fmin \\[calculated by Cockcroft and Gault equation\\]-confirmation of creatinine clearance is only required when creatinine is \\>1.5 times ULN.\n    8. INR ≤ 1.4 or aPTT ≤ 40 sec during the last 7 days before chemotherapy \\[Subjects under therapeutic anticoagulation are permitted.\\]\n12. Judgement 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.\n13. Women who are pregnant or breast-feeding\n14. Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 4 months (male patients) or 6 weeks (female patients) after the last dose of osimertinib and 6 months after the last dose of chemotherapy.\n15. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts \\[§ 40 Abs. 1 S. 3 Nr. 3a AMG\\].\n16. Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.\n17. Any chemotherapy, biologic, or hormonal therapy for cancer treatment used concurrently or within 6 months prior to first dose of study treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n18. Major surgery (as defined by the Investigator) within 4 weeks prior to starting the study; patients must have recovered from effects of preceding major surgery. Note: Local non-major surgery for palliative intent (e.g., surgery of isolated lesions) is acceptable","ALL","18 Years",{"count":18,"type":19},50,"ESTIMATED","INTERVENTIONAL",[22],"PHASE2","PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-naïve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.",[25,26],"NSCLC Stage IIIB","NSCLC Stage IV","RECRUITING","2025-02-20",{"date":30,"type":31},"2025-02-21","ACTUAL",{"date":33,"type":31},"2021-11-12",{"date":35,"type":19},"2026-11",{"name":37,"class":38},"Goethe University","OTHER",16,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100428914","phase-2-predicting-response-to-neoadjuvant-atezolizumab-plus-carboplatinnab-paclitaxel-in-resectable-non-squamous-nsclc-100428914","NCT04865250","Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin\u002FNab Paclitaxel in Resectable Non-squamous NSCLC","Exploratory Study Evaluating the Potential of Immune Signature Profiling for Predicting Response in Patients With Resectable Stage II, IIIA and Select IIIB (T3N2 Only) Non-squamous Non-Small Cell Lung Cancer (NSCLC) to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin\u002FNab Paclitaxel","iReP","Inclusion Criteria:\n\n* Informed consent, patients age ≥ 18-year-old including, signed and dated\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Histologically confirmed NSCLC of non-squamous histology, cStage II, IIIA or select IIIB (T3N2 only); for T-status ≤ T3 allowed; for N2 patients only IIIa1-3 Robinson classification allowed\n* Deemed surgically resectable with curative intent by an attending thoracic surgeon after adequate staging including PET-CT (positron emission tomography)\n* Adequate lung and cardiac function for intended lung resection according to German S3 regulation\n* Radiologically measurable disease as defined by response evaluation criteria in solid tumors RECIST v1.1\n* Sufficient availability of the tissue sample from primary tumor before start of neoadjuvant treatment\n* Females of child-bearing potential must agree to use, and be able to comply with, effective contraception (\\\u003C\u002F=1% failure rate annually) without interruption, 28 days prior to starting therapy (including dose interruptions), and while on study medication or for a period of 120 days after the last dose of study medication\n* Females must have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy.\n* Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following treatment discontinuation, even if he has undergone a successful vasectomy.\n* adequate renal, hepatic, and bone marrow function as defined below\n\n  * Absolute neutrophil count (ANC) \\> 1500\u002Fμl\n  * Platelet count ≥ 100000\u002Fμl\n  * Hemoglobin ≥ 9 g\u002Fdl (can be post-transfusion)\n  * International normalized ratio (INR) ≤ 1.4 in patients not receiving anticoagulation; for patients receiving respective anticoagulation an INR ≤3.0 allowed\n  * Activated partial thromboplastin time (aPTT) ≤ 1.5 times upper limit of normal (ULN) in patients not receiving anticoagulation; for patients receiving respective anticoagulation a PTT ≤2.5 ULN allowed\n  * Bilirubin \\\u003C 1.5 times ULN (for patients with known Gilbert disease Bilirubin ≤ 3 times ULN allowed)\n  * ALT and AST \\\u003C 2.5 times ULN\n  * Creatinine ≤ 1.5 ULN or calculated creatinine clearance \\> 60 ml\u002Fmin for subjects with creatinine levels \\> 1.5 ULN; for patients meeting the criterion of creatinine ≤ 1.5 ULN also a calculated creatinine clearance of \\> 30 ml\u002Fmin is mandatory\n\nExclusion Criteria:\n\n* Illness or condition that may interfere with a patient's capacity to understand, follow, and\u002For comply with study procedures\n* Treatment in any other clinical trial within 30 days before screening.\n* NSCLC Stage cT4\n* NSCLC stage cN3 or cN2 IIIA4 (bulky or fixed multi-station N2 disease) according to Robinson classification\n* NSCLC of squamous cell histology\n* Any prior therapy for lung cancer (including systemic therapy, radiotherapy or major surgery)\n* Malignancies other than NSCLC within 5 years prior to study inclusion with the exception of malignancies with a negligible risk of metastasis or death (5-year OS \\> 90%) like localized prostate cancer, ductal carcinoma in situ, adequately treated carcinoma in situ of the cervix, Stage I uterine cancer or non-melanoma skin carcinoma\n* History of allogeneic tissue \u002F solid organ transplant or allogeneic stem cell transplantation\n* Patients with active hepatitis B or C infections or a history of HIV infection\n* Pregnant or lactating women\n* Active autoimmune disease or history of severe autoimmune disease or immunodeficiency or a syndrome that requires systemic steroids or immunosuppressive agents\n* The following exceptions are granted:\n\n  * patients with vitiligo, eczema, lichen simplex or resolved childhood asthma\u002Fatopy\n  * subjects requiring intermittent use of bronchodilatators or local steroid injections\n  * patients with hypothyroidism stable on hormone replacement\n* Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor (anti-TNF) agents) within 2 weeks prior to Cycle 1, Day 1 (except low-dose steroids for adrenal failure or emesis prophylaxis)\n* History of idiopathic pulmonary fibrosis, interstitial lung disease, organizing pneumonia, drug-induced pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan\n* Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody\n* Live vaccine within 30 days prior to first dose of trial treatment\n* Cerebrovascular accident within the past 6 months\n* Severe infection or significant traumatic injury within the past 4 weeks\n* Clinically significant history of cardiovascular disease, including any of the following:\n\n  * Myocardial infarction or unstable angina within the past 6 months\n  * New York Heart Association class II, III-IV congestive heart failure\n  * Poorly controlled cardiac arrhythmia despite medication, except rate-controlled atrial fibrillation\n* Known allergy or hypersensitivity to any component of the chemotherapy regimen Patients who have been incarcerated or involuntarily institutionalized by court order or by the authorities, as well as patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial",{"count":49,"type":19},20,[22],"Exploratory study evaluating the potential of immune signature profiling for predicting response in patients with resectable Stage II, IIIA and select IIIB (T3N2 only) non-squamous Non-Small Cell Lung Cancer (NSCLC) to neoadjuvant ATEZOLIZUMAB plus Carboplatin\u002Fnab Paclitaxel\n\nAtezolizumab is given as intravenous infusion at a fixed dose of 1200 mg, day 1 of each 21-day cycle (every 3 weeks) for 3 cycles during the neoadjuvant treatment phase, Carboplatin at an initial dose of AUC (area under curve) 5 mg\u002FmL\u002Fmin, intravenously day 1 of each 21-day cycle for 3 cycles during the neoadjuvant treatment Phase, and Nab-Paclitaxel (Abraxane) at 100 mg\u002Fm2, intravenously day 1, 8 and 15 of each 21-day cycle for 3 cycles during the neoadjuvant treatment phase. Surgery after the 3rd cycle Atezolizumab \u002F Carboplatin \u002F Nab-Paclitaxel is standard procedure.",[53,54,25],"NSCLC Stage II","NSCLC, Stage IIIA","2024-05-13",{"date":57,"type":31},"2024-05-16",{"date":59,"type":31},"2021-01-07",{"date":61,"type":19},"2026-12-30",{"name":63,"class":38},"University Hospital Heidelberg",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":20,"phases":75,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":64},"100544843","exercise-in-patients-with-advanced-non-small-cell-lung-cancer-100544843","NCT06374160","Exercise in Patients With Advanced Non-small Cell Lung Cancer","Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer","BREATH","Inclusion Criteria\n\n* Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV\n* First- or second-line therapy (inclusion up to 28 days after the first cycle) in palliative intention\n* Age ≥ 18 years\n* Signed informed consent\n\nExclusion Criteria\n\n* Severe cardiopulmonary disease (EF\\\u003C30%)\n* Newly occurring or progressive uncontrolled CNS (central nervous system) metastases\n* Expected life expectancy \\\u003C 3 months\n* Bone metastases with acute risk of fracture\n* ECOG (Eastern Cooperative Oncology Group) performance status \\> 2\n* Acute pulmonary embolism\n* Acute myocardial infarction\n* Requiring surgery for aortic aneurysm\n* Tension pneumothorax\n* Lack of proficiency in the German language\n* Active infection",{"count":74,"type":19},104,[76],"NA","Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far.\n\nThe BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise\u002Fonly endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches.\n\nThe primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.",[79,80,81,26,25,82,83],"Advanced Lung Carcinoma","First Line Treatment","Second Line Treatment","Palliative Treatment","NSCLC Stage IIIC","NOT_YET_RECRUITING","2024-04-15",{"date":87,"type":31},"2024-04-18",{"date":89,"type":19},"2024-05-01",{"date":91,"type":19},"2026-08-31",{"name":93,"class":38},"University Hospital, Essen"]