[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione Ricerca Traslazionale\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":123},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,65,85,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100623132","phase-2-phase-ii-trial-of-amivantamab-plus-monochemotherapy-in-platinum-unfit-nsclc-patients-with-egfr-exon20-insertion-mutations-100623132",false,"NCT07392658","Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.","AMICUTE","Inclusion Criteria:\n\n* Written informed consent;\n* Male or female patient aged ≥18 years;\n* Histologically or cytologically confirmed stage IV or recurrent non-squamous NSCLC harboring EGFR exon20 insertion mutation;\n* No prior systemic treatment;\n* Unfit for platinum-based chemotherapy; Unfit for platinum is defined by a glomerular filtration rate (GFR) value less than 50 ml\u002Fmin\u002FBSA (body surface area) 1.73 m2 (or a CCR value of \\\u003C50 ml\u002Fmin) or age 80 years, presence of neurological disorders or hypersensitivity to platinum.\n* At least one radiological measurable disease according to RECIST criteria version 1.1;\n* Patients with brain metastases are eligible if they are asymptomatic and stable (i.e. without evidence of progression by imaging for at least two weeks prior to the first dose of trial treatment and without deterioration of any neurologic symptoms);\n* Performance status 0-2 (ECOG PS);\n* Patient compliance to trial procedures;\n* Adequate bone marrow function (ANC ≥ 1.5x109\u002FL, platelets ≥75x109\u002FL, haemoglobin \\>9 g\u002Fdl);\n* Adequate liver function (Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits, transaminases no more than 3xULN\u002F\\\u003C5xULN in presence of liver metastases);\n* Normal level of alkaline phosphatase and Serum creatinine \\\u003C1.5 x ULN and creatinine clearance \\>45 mL\u002Fmin as measured or calculated; refer to Appendix --Cockcroft-Gault Formula for Estimated creatinine clearance 12 Patients should be using adequate contraceptive measures, should not be breastfeeding, until 7 months after the last dose, and must have a negative pregnancy test (serum or urine) prior to first dose of study drug (within 72 hours) and must agree to further serum or urine pregnancy tests during the study; or female patients must have an evidence of non-childbearing potential by fulfilling one of the following criteria at screening: Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments; 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 luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution.\n\nA participant must be either of the following:\n\n* Not of childbearing potential\n* Of child-bearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of study treatment is given\n* Of childbearing potential and practicing 2 methods of contraception, including 1 highly effective user independent method and a second method (examples of highly effective methods of contraception are in section 9.6: Contraceptive Guidance and Collection of Pregnancy Information).\n\nA participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.\n\nA participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. A participant who is sexually active with a partner of childbearing potential must agree to use a condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository and their partner must also be practicing a highly effective method of contraception (ie, established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device \\[IUD\\] or intrauterine hormone-releasing system \\[IUS\\]).\n\nIf the participant is vasectomized, they must still use a condom (with or without spermicide) for prevention of passage of exposure through ejaculation, but their partner is not required to use contraception.\n\nA participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.\n\nNote: If the childbearing potential changes after start of the study (eg, participant of childbearing potential who is not heterosexually active becomes active, premenarchal participant experiences menarche) the participant must begin birth control, as described above.\n\nExclusion Criteria:\n\n* Uncontrolled infectious liver disease;\n* Positive hepatitis B (hepatitis B virus \\[HBV\\]) surface antigen (HBsAg) Note: participants with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.\n* Positive hepatitis C antibody (anti-HCV). Note: participants with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.\n* Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:\n\nReceiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment) CD4 count \\\u003C350 at screening AIDS-defining opportunistic infection within 6 months of start of screening Not agreeing to start ART and be on ART\\>4 weeks plus having HIV viral load \\\u003C400 copies\u002FmL at end of 4-week period (to ensure ART is tolerated and HIV controlled).\n\n-Participant has active cardiovascular disease including, but not limited to: A medical history of deep vein thrombosis or pulmonary embolism within 1 month prior to randomization or any of the following within 6 months prior to randomization: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary\u002Fperipheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated thrombus, incidental or asymptomatic pulmonary embolism, are not exclusionary.\n\n* Uncontrolled (persistent) hypertension: systolic blood pressure \\>160 mm Hg; diastolic blood pressure \\>100 mm Hg.\n* Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class; refer to Appendix 6: New York Heart Association Criteria) within 6 months of randomization.\n* Participant has an uncontrolled illness, including but not limited to:\n\nUncontrolled diabetes Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy \\[participants will be required to complete antibiotics 1 week prior to starting study treatment\\] or diagnosed or suspected viral infection.\n\nActive bleeding diathesis Impaired oxygenation requiring continuous oxygen supplementation Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements Any ophthalmologic condition that is clinically unstable\n\n* Absence of measurable lesions;\n* Concomitant radiotherapy;\n* Previous treatment with any EGFR Exon20ins-targeted TKIs;\n* Symptomatic or immediately requiring therapy for brain metastases or carcinomatous meningitis. Subjects with asymptomatic and stable or treated brain metastases may participate;\n* Participant has concurrent or prior malignancy other than the disease under study. The following exceptions require consultation with the Medical Monitor:\n\n  1. Non-muscle invasive bladder cancer (NMIBC) treated within the last 24 months that is considered completely cured.\n  2. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.\n  3. Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.\n* Participant had major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 4 weeks before randomization, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study.\n\nNote: Participants with planned surgical procedures to be conducted under local anesthesia may participate.\n\n* History of extensive disseminated\u002Fbilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis;\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV);\n* Pregnancy or lactating female;\n* Other serious illness or medical condition potentially interfering with the study.","ALL","18 Years","99 Years",{"count":20,"type":21},33,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","To assess safety and efficacy of amivantamab plus monochemotherapy in terms of ORR, PFS and OS in subjects with EGFR exon20 insertion mutations metastatic non-small cell lung cancer unfit for platinum-based chemotherapy.",[27],"Metastatic NSCLC - Non-Small Cell Lung Cancer","RECRUITING","2026-02-05",{"date":31,"type":32},"2026-02-06","ACTUAL",{"date":34,"type":32},"2025-12-02",{"date":36,"type":21},"2028-10",{"name":38,"class":39},"Fondazione Ricerca Traslazionale","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100579369","study-investigating-anti-drug-antibodies-in-nsclc-patients-exposed-to-checkpoint-inhibitors-imb-100579369","NCT06823401","Study Investigating Anti-drug Antibodies in NSCLC Patients Exposed to Checkpoint Inhibitors (IMB)","IMMUNOBLOOD: Perspective Study for the Evaluation of Anti-Inhibitory Checkpoint Antibody Development in Patients Undergoing Immunotherapy","IMB","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of NSCLC\n* Possibility to obtain blood samples\n* Patient candidate, in any therapy line, for a therapy with any checkpoint inhibitor including single agent pembrolizumab, single agent atezolizumab, single agent nivolumab, single agent durvalumab or combination of nivolumab and ipilimumab\n* Performance status 0-2 (ECOG)\n* Patient compliance to trial procedures\n* Age ≥ 18 years\n* Written informed consent\n\nExclusion Criteria:\n\n* No possibility to obtain blood samples\n* Previous therapy with any checkpoint inhibitor\n* Patient candidate for a therapy with a checkpoint inhibitor in combination with chemotherapy or any other non-checkpoint inhibitors\n* Pregnancy or lactating",{"count":50,"type":21},270,"2 Years","OBSERVATIONAL","Non-small cell lung cancer (NSCLC) is one of the leading causes of death in Western countries. Today, a new frontier in the fight against cancer is immunotherapy, a treatment that aims to \"awaken\" the patient's immune system to help it recognize and attack cancer cells.\n\nAmong the various approaches, there is significant focus on therapies that activate T lymphocytes, a type of immune cell, encouraging them to react against the tumor. These treatments have led to important progress and represent a hope for the future.",[55],"NSCLC",[57],"immunotherapy",{"date":31,"type":32},{"date":60,"type":32},"2021-05-20",{"date":62,"type":21},"2029-12-31",{"name":38,"class":39},2,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":40},"100613291","phase-2-a-randomized-phase-ii-trial-of-cemiplimab-plus-ose2101--tedopi-as-maintenance-therapy-in-ctdna-positive-nscl-the-cemited-study-100613291","NCT07264673","A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.","Cemited","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of non- oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation therapy) or metastatic non-small-cell lung cancer (NSCLC)\n* Any patient candidate for first line chemo-immunotherapy irrespective of PD-L1 levels\n* HLA-A2 positive\n* ECOG PS 0-1\n* Signed informed consent (IC) prior to any trial-specific procedures\n\nExclusion Criteria:\n\n* Patients not candidate for chemo-immunotherapy\n* HLA-A2 negative\n* Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated\n* Tumor tissue not available (archive or collected before trial inclusion)\n* Evidence of EGFR mutations or ALK or ROS1 rearrangements\n* Performance status \\>1 (ECOG)\n* Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma(squamous or basaloid)",{"count":73,"type":21},160,[24],"This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy.",[55],"2025-11-24",{"date":79,"type":32},"2025-12-04",{"date":81,"type":32},"2025-04-17",{"date":83,"type":21},"2029-10",{"name":38,"class":39},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":97,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":40},"100613289","phase-2-neoadjuvant-chemo-immunotherapy-for-stage-iii-pd-l1-positive-non-small-cell-lung-cancer-nsclc-100613289","NCT07264647","Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* Histologically confirmed stage III disease.\n\n  * PD-L1 TPS ≥ 1% according to local testing.\n  * No evidence of EGFR mutations or ALK or ROS1 or RET rearrangements by local testing.\n\nMandatory baseline multidisciplinary assessment to confirm suitability of patient to local treatment with curative intent.\n\n* Pulmonary function tests within 6 months of the planned resection.\n* At least 1 measurable lesion as defined by RECIST v1.1.\n* ECOG Performance Status ≤ 1.\n* Eligibility to receive a platinum doublet chemotherapy regimen.\n* Adequate organ function as indicated by the following laboratory values obtained ≤ 14 days before the first dose of study drug:\n\nPatients must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following:\n\nAbsolute neutrophil count ≥ 1.5 x 109 \u002FL Platelets ≥ 75 x 109 \u002FL Hemoglobin ≥ 90 g\u002FL Estimated glomerular filtration rate ≥ 45 mL\u002Fmin\u002F1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (Appendix 9).\n\nFor patients intended to receive cisplatin: creatinine clearance 60mL\u002Fmin For patients intended to receive carboplatin: creatinine clearance 45mL\u002Fmin Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (total bilirubin must be \\\u003C 3 x ULN for patients with Gilberts syndrome).\n\nAST and ALT ≤ 2.5 x ULN For patients not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time 1.5ULN\n\n* Age ≥ 18 years.\n* Written informed consent.\n\nExclusion Criteria:\n\nEvidence of stage IV NSCLC (metastatic disease).\n\n* Histology of large cell neuroendocrine carcinoma (LCNEC).\n* Any previous therapy for current lung cancer, including chemotherapy or radiation therapy.\n* Previous treatment with an antibody or drug against the immune checkpoint pathway, including but not limited to, therapeutic anti-cytotoxic T-lymphocyte antigen-4-associated antibodies (anti-CTLA-4), anti-PD-1 and anti-PD-L1.\n* Never smoking patients.\n* Active autoimmune diseases or history of autoimmune diseases that may recur.\n* Concomitant participation in another therapeutic clinical trial.\n* Pregnancy or breastfeeding.",{"count":92,"type":21},30,[24],"A Ph.2, single-arm, monocentric, trial of neo-adjiuvant chemo-immunotherapy for stage III, PD-L1 positive, NSCLC.\n\nAdults and smokers (past or current) diagnosed with stage III NSCLC without driver molecular alterations (EGFR, ALK, ROS1, RET).",[96],"Stage III NSCLC",{"date":79,"type":32},{"date":99,"type":32},"2025-03-27",{"date":101,"type":21},"2030-02-01",{"name":38,"class":39},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":40},"100482913","phase-2-randomized-trial-comparing-standard-of-care-versus-immune--based-combination-in-relapsed-stage-iii-non-small-cell-lung-cancer-nsclc-pretreated-with-chemoradiotherapy-and-durvalumab-100482913","NCT05568212","Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab","Phase II, Two-cohorts, Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab (MEDI4736)","Inclusion Criteria:\n\n1. Body weight \\>30kg\n2. Recurrent or metastatic NSCLC relapsed during or after completion of chemoradiotherapy with curative intent and maintenance durvalumab for stage III disease. Patients are eligible if they receive at least two cycles of platinum based chemotherapy or radical radiotherapy\n3. Tumor tissue available for biomarker testing.\n4. Evidence of disease progression during durvalumab maintenance or at the end of planned treatment. Patients who have interrupted planned durvalumab treatment after at least 6 months for reasons other than toxicity or progression (e.g. patient's choice, logistic reasons, intercurrent acute illnesses) are eligible. Patients progressing during the first three months of Durvalumab are not eligible\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n6. 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\n7. Age \\>18 years at time of study entry\n8. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations.\n9. Life expectancy of at least 16 weeks\n10. Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below::\n\n    * Haemoglobin ≥10.0 g\u002FdL with no blood transfusion in the past 28 days\n    * Absolute neutrophil count (ANC) ≥1.5 × 109 \u002FL\n    * Platelet count ≥100 × 109\u002FL\n    * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.\n    * AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n    * creatinine clearance estimated of ≥51 mL\u002Fmin using the Cockcroft-Gault equation or based on a 24 hour urine test:\n\n    Males:\n\n    Creatinine CL = Weight (kg) x (140 - Age) (mL\u002Fmin) ---------------------------------------- 72 x serum creatinine (mg\u002FdL)\n\n    Females:\n\n    Creatinine CL = Weight (kg) x (140 - Age) (mL\u002Fmin) ----------------------------------------- x 0.85 72 x serum creatinine (mg\u002FdL)\n11. Female patients should be using adequate contraceptive measures (highly effective method of contraception are present in table 3 of protocol \"Highly Effective Methods of Contraception (\\\u003C1% Failure Rate)\"), should not be breastfeeding, from the time of screening throughout the total duration of the drug treatment and the drug washout period (90 days after the last dose of durvalumab monotherapy) or for at least 1 month after last dose of olaparib, or they must totally\u002Ftruly abstain from any form of sexual intercourse. Females of childbearing potential are defined as those who are not surgically sterile (ie, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal.\n12. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days of study treatment and confirmed prior to treatment on day 1.\n\n    Postmenopausal is defined as:\n    * Amenorrheic for 1 year or more following cessation of exogenous hormonal treatments\n    * Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post menopausal range for women under 50\n    * radiation-induced oophorectomy with last menses \\>1 year ago\n    * chemotherapy-induced menopause with \\>1 year interval since last menses\n    * surgical sterilisation (bilateral oophorectomy or hysterectomy)\n\n    The following age-specific requirements apply:\n    * Women \\\u003C50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution.\n    * Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago.\n13. Male patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception if they are of childbearing potential. Male patients should not donate sperm throughout the period of taking olaparib and for 3 months following the last dose of Olaparib.\n\nExclusion Criteria:\n\n1. No evidence of disease progression\n2. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment\n3. Patients not pretreated with durvalumab with curative intent\n4. Patients treated with non-radical radiotherapy or with non conventional radiotherapy\n5. More than 4 cycles of platinum-based chemotherapy\n6. Rapid progressors. Progressors within first 3 month of treatment will be excluded from this trial\n7. Any clinical reason that makes the patient ineligible to receive any investigator's choice single-agent chemotherapy regimen (for patients enrolled in cohorts A and B)\n8. Any clinical reason that makes the patient ineligible to receive any investigator's choice platinum-based doublet chemotherapy regimen (for patients enrolled in cohorts C and D)\n9. Persistent toxicities (\\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.\n10. Patients with myelodysplastic syndrome\u002Facute myeloid leukaemia or with features suggestive of MDS\u002FAML.\n11. Disease progression within the first three months of Durvalumab therapy\n12. Tumor tissue not available\n13. Evidence of EGFR mutations or ALK or ROS1 rearrangements\n14. Performance status \\>1 (ECOG)\n15. Brain metastases are allowed if asymptomatic and pretreated. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment.\n16. Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma (squamous or basaloid)\n17. Patient with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days prior to enrolment..\n18. Leptomeningeal disease.\n19. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation \\>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.\n20. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.\n21. Malignancies other than NSCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS\\> 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent, grade 1 endometrial carcinoma)\n22. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins and patient with a known hypersensitivity to olaparib or any of the excipient of the product.\n23. Known hypersensitivity or allergy to any component of the Durvalumab formulation\n24. History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, p psoriatic arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain- Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with: 1) history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone, 2) controlled Type I diabetes mellitus who are receiving a stable dose of insulin regimen and 3) eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only in less than 10% of body surface area, well controlled at baseline and only requiring low potency topical steroids are eligible for this study.\n25. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.\n26. Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.\n27. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n28. Positive test for HIV\n29. Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[HBc Ab\\] and absence of HBsAg) are eligible. HBV DNA must be obtained in these patients prior to randomization. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA.\n30. Active tuberculosis\n31. Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg.\n\n    ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks.\n32. Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.\n33. Major surgery within 2 weeks of starting study treatment and patients must have recovered from any effects of any major surgery.\n34. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).\n35. Pregnancy or breast feeding women",{"count":111,"type":21},176,[24],"This is a randomized, non-comparative, phase II study investigating whether: 1) the addition of durvalumab to investigator's choice second line chemotherapy prolongs survival versus investigator's choice second line chemotherapy in NSCLC patients with locally advanced disease progressing on durvalumab given after concomitant chemoradiotherapy; 2) whether the addition of olaparib to durvalumab improves survival over durvalumab alone after induction chemoimmunotherapy in patients relapsing after completing durvalumab maintenance therapy for stage III disease.\n\nAfter evaluation of inclusion and exclusion criteria and after consent form signature, all eligible patients progressing during durvalumab therapy will be in the Part A of the trial randomized to in a 1:1 ratio to investigator's choice single-agent chemotherapy plus durvalumab (Arm A: experimental arm) or to investigator's choice single-agent chemotherapy (Arm B: standard arm). In the clinical trial's Part B, patients progressing after completion of durvalumab therapy will be further randomized in a 1:1.7 ratio to investigator's choice platinum doublet chemotherapy plus durvalumab for 4 cycles followed by maintenance durvalumab plus olaparib (Arm C: experimental arm) or to investigator's choice platinum doublet chemotherapy plus durvalumab for 4 cycles followed by durvalumab (Arm D: experimental arm). Therapy will be continued up to disease progression, toxicity or patient refusal.",[115],"Non-small-cell Lung Cancer Patients",{"date":117,"type":32},"2025-12-01",{"date":119,"type":32},"2022-05-02",{"date":121,"type":21},"2027-05",{"name":38,"class":39},""]