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The tumor bed is defined as the area of tissue occupied by viable tumor or tumoral regression (includes areas of necrosis, foamy macrophages, giant cell reaction, cholesterol cleft granuloma, and inflammation.)",[17,21,24,27,30,33,37,40,43,46,49],{"measure":18,"description":19,"timeFrame":20},"Percentage of Participants Who Report at Least 1 Adverse Event (AE)","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.","Up to approximately 5 years",{"measure":22,"description":19,"timeFrame":23},"Percentage of Participants Who Discontinue Study Treatment Due to an AE","Up to approximately 1 year",{"measure":25,"description":26,"timeFrame":20},"Event-free Survival (EFS)","EFS is defined as the time from randomization to any of the following events: radiographic disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) (for participants who have not had or will not have surgery, or participants who have gross residual disease after an incomplete resection \\[R2 resection\\]); local progression (primary tumor or regional lymph nodes) or distant metastasis precluding planned surgery; tumor determined to be unresectable in the operating room; local or distant recurrence (for participants who are disease free after surgery or participants with microscopic positive margins \\[R1 resection\\]); occurrence of new primary NCSLC; death due to any cause.",{"measure":28,"description":29,"timeFrame":20},"Overall Survival (OS)","OS is defined as the time from randomization to death due to any cause.",{"measure":31,"description":32,"timeFrame":20},"Distant Metastasis-Free Survival (DMFS)","DMFS is defined as the time from randomization to the date of diagnosis of distant metastasis or death, whichever occurs first.",{"measure":34,"description":35,"timeFrame":36},"Objective Response Rate (ORR)","OR is defined as a complete response or partial response with or without confirmation per RECIST 1.1 as assessed by the investigator during the Neoadjuvant Phase.","Up to approximately 12 weeks",{"measure":38,"description":39,"timeFrame":12},"Percentage of Participants Who Experience a Perioperative Complication","Perioperative Complications include both intraoperative and postoperative complications.",{"measure":41,"description":42,"timeFrame":12},"Mean Length of Hospital Stay","Hospital Stay is the length of inpatient time spent in hospital.",{"measure":44,"description":45,"timeFrame":12},"Percentage of Participants Who Require Hospital Readmission after Discharge","In participants previously discharged from hospital, the percentage requiring readmission to hospital.",{"measure":47,"description":48,"timeFrame":12},"Mean Length of Surgery","Length of surgery is the time spent in surgery.",{"measure":50,"description":51,"timeFrame":12},"Percentage of Participants Who Require a Blood Transfusion","Blood transfusion is the transfer of donated blood into the vein of a recipient.",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":52,"primaryPurpose":56,"observationalModel":52,"timePerspective":52,"maskingInfo":57},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":58,"maskingDescription":52,"whoMasked":52},"NONE",[60,72],{"label":61,"type":62,"description":63,"interventionNames":64},"Pembrolizumab + Platinum","ACTIVE_COMPARATOR","Neoadjuvant: Prior to surgery pembrolizumab 200 mg every three weeks (Q3W) for 4 cycles (each cycle is 21 days); Cisplatin 75 mg\u002Fm\\^2 Q3W with gemcitabine 1000 mg\u002Fm\\^2 on Day 1 and Day 8 Q3W (squamous tumors), pemetrexed 500 mg\u002Fm\\^2 Q3W (nonsquamous tumors), or paclitaxel 175 mg\u002Fm\\^2 or 200 mg\u002Fm\\^2 q3w (any histology) OR Carboplatin AUC 5 mg\u002FmL• min or AUC 6 mg\u002FmL• min with paclitaxel 175 mg\u002Fm\\^2 or 200 mg\u002Fm\\^2 Q3W (any histology), pemetrexed 500 mg\u002Fm\\^2 Q3W (nonsquamous tumors), or gemcitabine 1000 mg\u002Fm\\^2 on Day 1 and Day 8 Q3W (squamous tumors); followed by surgery.\n\nAdjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days).",[65,66,67,68,69,70,71],"Biological: Pembrolizumab (neoadjuvant)","Drug: Cisplatin","Drug: Gemcitabine","Drug: Pemetrexed","Drug: Carboplatin","Biological: Pembrolizumab (adjuvant)","Drug: Paclitaxel",{"label":73,"type":74,"description":75,"interventionNames":76},"Pembrolizumab + Sacituzumab tirumotecan","EXPERIMENTAL","Neoadjuvant: Prior to surgery pembrolizumab 200 mg Q3W for 4 cycles (each cycle is 21 days); sacituzumab tirumotecan 4 mg\u002Fkg Q2W for 6 cycles (each cycle is 14 days), followed by surgery.\n\nAdjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days). 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2313301848",{"facility":328,"status":164,"city":305,"state":306,"zip":329,"country":308,"countryCode":309,"cosmosGeoPoint":330,"geoPoint":332,"contacts":333},"Metropolitan Hospital-4th Oncology Dept ( Site 0201)","185 47",{"type":171,"coordinates":331},[312,313],{"lat":313,"lon":312},[334],{"name":178,"role":158,"phone":335,"phoneExt":52,"email":52},"0030 2104807106",{"facility":337,"status":164,"city":338,"state":339,"zip":340,"country":308,"countryCode":309,"cosmosGeoPoint":341,"geoPoint":345,"contacts":346},"University General Hospital of Heraklion ( Site 0200)","Heraklion","Irakleio","71110",{"type":171,"coordinates":342},[343,344],25.14341,35.32787,{"lat":344,"lon":343},[347],{"name":178,"role":158,"phone":348,"phoneExt":52,"email":52},"0030 2810392091",{"facility":350,"status":164,"city":351,"state":352,"zip":353,"country":354,"countryCode":355,"cosmosGeoPoint":356,"geoPoint":360,"contacts":361},"Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 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Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)","Lviv","Lviv Oblast","79059",{"type":171,"coordinates":600},[601,602],24.02324,49.83826,{"lat":602,"lon":601},[605],{"name":178,"role":158,"phone":606,"phoneExt":52,"email":52},"380977453295",{"facility":608,"status":164,"city":609,"state":610,"zip":611,"country":558,"countryCode":559,"cosmosGeoPoint":612,"geoPoint":616,"contacts":617},"ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)","Rivne","Rivne Oblast","33010",{"type":171,"coordinates":613},[614,615],26.23695,50.62036,{"lat":615,"lon":614},[618],{"name":178,"role":158,"phone":619,"phoneExt":52,"email":52},"380503802915",{"facility":621,"status":164,"city":622,"state":623,"zip":624,"country":558,"countryCode":559,"cosmosGeoPoint":625,"geoPoint":629,"contacts":630},"Communal Noncommercial Enterprise \"Podillia Regional Oncology Center Of Vinnytsia Regional Council\" ( Site 0135)","Vinnytsia","Vinnytsia Oblast","21029",{"type":171,"coordinates":626},[627,628],28.46871,49.2322,{"lat":628,"lon":627},[631],{"name":178,"role":158,"phone":632,"phoneExt":52,"email":52},"0988936318",{"facility":634,"status":164,"city":635,"state":52,"zip":636,"country":558,"countryCode":559,"cosmosGeoPoint":637,"geoPoint":641,"contacts":642},"Shalimov Institute of Surgery and Transplantation ( Site 0138)","Kyiv","03126",{"type":171,"coordinates":638},[639,640],30.5238,50.45466,{"lat":640,"lon":639},[643],{"name":178,"role":158,"phone":644,"phoneExt":52,"email":52},"093 33 33 911",{"type":646,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100576716","phase-2-pembrolizumab-mk-3475-plus-investigational-agents-in-resectable-non-small-cell-lung-cancer-nsclc-mk-3475-01ekeymaker-u01-100576716",false,"NCT06788912","Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E\u002FKEYMAKER-U01)","KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC)\n* Able to undergo protocol therapy, including necessary surgery\n* Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.\n* Is able to provide archival or newly obtained core\u002Fexcisional biopsy of the primary lung tumor or lymph node metastasis.\n\nExclusion Criteria:\n\n* Has one of the following tumor locations\u002Ftypes: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.\n* Has Grade ≥2 peripheral neuropathy.\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Active infection requiring systemic therapy.\n* Hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \\[qualitative\\]) infection.\n* Known history of human immunodeficiency virus (HIV) infection.\n* History of allogeneic tissue\u002Fsolid organ transplant.","ALL","18 Years",{"count":657,"type":658},60,"ESTIMATED","INTERVENTIONAL",[661],"PHASE2","The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.",[664],"Lung Neoplasm Malignant",[666,667,668],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","2026-06-25",{"date":671,"type":672},"2026-06-26","ACTUAL",{"date":674,"type":672},"2025-03-20",{"date":676,"type":658},"2032-02-06",{"name":5,"class":6},38]