[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383070":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":230,"centralContacts":229,"locations":235,"responsibleParty":11706,"collaborators":229,"id":11708,"slug":229,"hasResults":11709,"nctId":11710,"briefTitle":11711,"officialTitle":11712,"acronym":229,"eligibilityCriteria":11713,"healthyVolunteers":11709,"sex":11714,"minAge":11715,"maxAge":229,"enrollmentInfo":11716,"targetDuration":229,"studyType":11719,"phases":11720,"briefSummary":11722,"conditions":11723,"keywords":229,"overallStatus":279,"whyStopped":229,"lastUpdateSubmitDate":11730,"lastUpdatePostDateStruct":11731,"startDateStruct":11734,"completionDateStruct":11736,"leadSponsor":11738,"locationsCount":11739},{"fullName":5,"class":6},"National Cancer Institute (NCI)","NIH",[8,24,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A (platinum doublet, observation)","ACTIVE_COMPARATOR","INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens based on the treating physician's choice of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.\n\nCONTINUANCE THERAPY: Patients then undergo observation.\n\nPatients also undergo ECHO as clinically indicated during screening and on the trial. Patients may undergo MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial.\n\n(CLOSED AS OF UPDATE #7)",[13,14,15,16,17,18,19,20,21,22,23],"Procedure: Biospecimen Collection","Drug: Carboplatin","Drug: Cisplatin","Procedure: Computed Tomography","Procedure: Echocardiography Test","Drug: Gemcitabine Hydrochloride","Procedure: Magnetic Resonance Imaging","Other: Observation Activity","Drug: Paclitaxel","Drug: Pemetrexed Disodium","Other: Questionnaire Administration",{"label":25,"type":26,"description":27,"interventionNames":28},"Arm B (platinum doublet, sequential pembrolizumab)","EXPERIMENTAL","INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens\\* based on the treating physician's choice of each cycle and pembrolizumab IV over 25-40 minutes on day 1 of each cycle or for cycles 1 and 3 (patients enrolled after 10\u002F14\u002F2020). Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.\n\nCONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10\u002F14\u002F2020) in the absence of disease progression or unacceptable toxicity.\n\nPatients also undergo ECHO as clinically indicated during screening and on the trial. Patients may undergo MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial.",[13,14,15,16,17,18,19,21,29,22,23],"Biological: Pembrolizumab",{"label":31,"type":26,"description":32,"interventionNames":33},"Arm C (platinum doublet, combination pembrolizumab)","INITIAL THERAPY: Patients receive 1 of 4 platinum doublet regimens\\* based on the treating physician's choice of each cycle and pembrolizumab IV over 25-40 minutes on day 1 of each cycle or for cycles 1 and 3 (patients enrolled after 10\u002F14\u002F2020). Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.\n\nCONTINUANCE THERAPY: Patients then receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Treatment repeats every 21 days for 13 cycles or every 6 weeks for 12 cycles (patients enrolled after 10\u002F14\u002F2020) in the absence of disease progression or unacceptable toxicity.\n\nPatients also undergo ECHO as clinically indicated during screening and on the trial. Patients may undergo a MRI during screening and as clinically indicated on the trial, as well as CT and blood sample collection throughout the trial.",[13,14,15,16,17,18,19,21,29,22,23],[35,45,71,117,134,141,152,172,179,189,217,225],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"PROCEDURE","Biospecimen Collection","Undergo blood sample collection",[9,25,31],[41,42,43,44],"Biological Sample Collection","Biospecimen Collected","Sample Collection","Specimen Collection",{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Carboplatin","Given IV",[9,25,31],[51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70],"Blastocarb","Carboplat","Carboplatin Hexal","Carboplatino","Carboplatinum","Carbosin","Carbosol","Carbotec","CBDCA","Displata","Ercar","JM-8","JM8","Nealorin","Novoplatinum","Paraplatin","Paraplatin 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Diamminodichloride","Platiran","Platistin","Platosin",{"type":36,"name":118,"description":119,"armGroupLabels":120,"otherNames":121},"Computed Tomography","Undergo CT",[9,25,31],[122,123,124,125,126,127,128,129,130,131,132,133],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","Diagnostic CAT Scan","Diagnostic CAT Scan Service Type","tomography",{"type":36,"name":135,"description":136,"armGroupLabels":137,"otherNames":138},"Echocardiography Test","Undergo ECHO",[9,25,31],[139,140],"EC","Echocardiography",{"type":46,"name":142,"description":48,"armGroupLabels":143,"otherNames":144},"Gemcitabine Hydrochloride",[9,25,31],[145,146,147,148,149,150,151],"dFdCyd","Difluorodeoxycytidine Hydrochloride","Gemcitabine HCI","Gemzar","LY 188011","LY-188011","LY188011",{"type":36,"name":153,"description":154,"armGroupLabels":155,"otherNames":156},"Magnetic Resonance Imaging","Undergo MRI",[9,25,31],[157,158,159,160,161,162,163,164,165,166,167,168,169,170,171],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":173,"name":174,"description":175,"armGroupLabels":176,"otherNames":177},"OTHER","Observation Activity","Undergo observation",[9],[178],"Observation",{"type":46,"name":180,"description":48,"armGroupLabels":181,"otherNames":182},"Paclitaxel",[9,25,31],[183,184,185,186,187,188],"Anzatax","Asotax","Bristaxol","Praxel","Taxol","Taxol 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Associates in Radiation Medicine","SUSPENDED","Anchorage","Alaska","98508","United States","US",{"type":245,"coordinates":246},"Point",[247,248],-149.90028,61.21806,{"lat":248,"lon":247},{"facility":251,"status":238,"city":239,"state":240,"zip":252,"country":242,"countryCode":243,"cosmosGeoPoint":253,"geoPoint":255,"contacts":229},"Anchorage Radiation Therapy Center","99504",{"type":245,"coordinates":254},[247,248],{"lat":248,"lon":247},{"facility":257,"status":238,"city":239,"state":240,"zip":258,"country":242,"countryCode":243,"cosmosGeoPoint":259,"geoPoint":261,"contacts":229},"Alaska Breast Care and Surgery LLC","99508",{"type":245,"coordinates":260},[247,248],{"lat":248,"lon":247},{"facility":263,"status":238,"city":239,"state":240,"zip":258,"country":242,"countryCode":243,"cosmosGeoPoint":264,"geoPoint":266,"contacts":229},"Alaska Oncology and Hematology LLC",{"type":245,"coordinates":265},[247,248],{"lat":248,"lon":247},{"facility":268,"status":238,"city":239,"state":240,"zip":258,"country":242,"countryCode":243,"cosmosGeoPoint":269,"geoPoint":271,"contacts":229},"Alaska Women's Cancer Care",{"type":245,"coordinates":270},[247,248],{"lat":248,"lon":247},{"facility":273,"status":238,"city":239,"state":240,"zip":258,"country":242,"countryCode":243,"cosmosGeoPoint":274,"geoPoint":276,"contacts":229},"Anchorage Oncology Centre",{"type":245,"coordinates":275},[247,248],{"lat":248,"lon":247},{"facility":278,"status":279,"city":239,"state":240,"zip":258,"country":242,"countryCode":243,"cosmosGeoPoint":280,"geoPoint":282,"contacts":283},"Katmai Oncology Group","RECRUITING",{"type":245,"coordinates":281},[247,248],{"lat":248,"lon":247},[284,289],{"name":285,"role":286,"phone":287,"phoneExt":229,"email":288},"Site Public Contact","CONTACT","907-212-6871","AKPAMC.OncologyResearchSupport@providence.org",{"name":290,"role":234,"phone":229,"phoneExt":229,"email":229},"Alison K. 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hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)\n* Local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)\n* Local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263\n* Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 8th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2017\n\n  * Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population\n* Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery\n* No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis\n* No prior allogeneic tissue\u002Fsolid organ transplant\n* Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements\n* No current pneumonitis or history of (non-infectious) pneumonitis that required steroids\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1\n* No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test done =\\\u003C 7 days prior to registration is required\n* No patients with a \"currently active\" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers, low grade or low-risk cancers, or stage I malignancies not requiring systemic therapy (e.g., prostate cancer requiring only observation or superficial bladder cancer), or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible\n* No hypersensitivity (\\>= grade 3) to pembrolizumab and\u002For any of its excipients\n* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed\n* No known hepatitis C virus (defined as HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected) infection or known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive)\n* Absolute neutrophil count (ANC) \\>= 1,500\u002Fmm\\^3\n* Platelet count \\>= 100,000\u002Fmm\\^3\n* Hemoglobin \\>= 8 gm\u002Fdl\n* Calculated (Calc.) creatinine clearance \\>= 45 mL\u002Fmin\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) =\\\u003C 2.5 x upper limit of normal (ULN)","ALL","18 Years",{"count":11717,"type":11718},1210,"ESTIMATED","INTERVENTIONAL",[11721],"PHASE3","This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, 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. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.",[11724,11725,11726,11727,11728,11729],"Lung Non-Small Cell Carcinoma","Lung Non-Small Cell Squamous Carcinoma","Lung Non-Squamous Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8","2026-07-01",{"date":11732,"type":11733},"2026-07-02","ACTUAL",{"date":11735,"type":11733},"2020-06-16",{"date":11737,"type":11718},"2027-01-31",{"name":5,"class":6},1150]