[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07476287":3,"trial-entities:NCT07476287":356,"trial-summary:NCT07476287":361},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":25,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":54,"sex":73,"minimum_age":74,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":75,"std_ages":115,"locations":118,"central_contacts":342,"overall_officials":348,"references":351,"see_also_links":352},"NCT07476287","C6461014","Symbiotic-Lung-14: A Study to Learn About the Study Medicine Called PF08634404 in Combination With Chemotherapy in Adult Participants With Transformed Small Cell Lung Cancer","A PHASE 2 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH PREVIOUSLY UNTREATED TRANSFORMED SMALL CELL LUNG CANCER","RECRUITING","2031-03-19","2026-08","2026-08-17","2026-07-02","Pfizer","INDUSTRY",false,"This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses medicines to destroy cancer cells or stop them from growing. The study is for adults with Transformed Small Cell Lung Cancer (T-SCLC ). T SCLC is a rare lung cancer that happens when one type of lung cancer changes into a more aggressive type after treatment stops working.\n\nTo join the study, participants must meet the following conditions:\n\n* Are aged 18 years or older\n* Diagnosed with T-SCLC and have not received treatment for this type of lung cancer (a single cycle of chemotherapy may be permitted)\n* Prior diagnosis of epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer treated with tyrosine kinase inhibitors (TKIs)\n* Have healthy organs based on medical tests and are in good physical condition\n\nAfter joining the study, adults will be given chemotherapy in addition to the study medicine. After this combination treatment is finished, the study medicine will be continued alone. Adults will receive the treatment through IV infusions (medicine given directly into a vein). All treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",null,[19,20,21,22,23,24],"Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Transformed Small Cell Lung Cancer","Lung Neoplasms","Carcinoma, Small Cell Lung","Small Cell Cancer Of The Lung",[21,19],"INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},40,"ESTIMATED",[34,41],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","PF-08634404","Concentrate for solution for infusion",[36],[40],"SSGJ-707",{"type":35,"name":42,"description":43,"armGroupLabels":44},"Chemotherapy","Injection for intravenous use",[36],[46,50],{"measure":47,"description":48,"timeFrame":49},"Confirmed Objective Response Rate (ORR) as assessed by investigator based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)","Defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response. ORR using RECIST v1.1 as assessed by investigator.","From start of treatment until first documented CR or PR (approximately maximum up to 1 years)",{"measure":51,"description":52,"timeFrame":53},"Number of Participants with Adverse Events (AEs)","Adverse Events (AEs) as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.","Up to 90 days after the last dose of treatment",[55,59,62,65,68,71],{"measure":56,"description":57,"timeFrame":58},"Duration of Response (DOR) as assessed by investigator based on RECIST v1.1","DOR is defined as the time from the first documentation of objective response (CR or PR) to the date of first documentation of disease progression (PD) or death due to any cause.","Up to approximately 2 years after completion of study treatment of last study participant",{"measure":60,"description":61,"timeFrame":58},"Progression Free Survival (PFS) as assessed by investigator based on RECIST v1.1","PFS is defined as the time from the date of randomization to the date of first documented disease progression, per RECIST v1.1, or death to any cause, whichever occurs first",{"measure":63,"description":64,"timeFrame":58},"Overall Survival (OS)","OS is defined as the time from the date of randomization to the date of death due to any cause. OS is secondary outcome measure in Phase 2 portion of the study.",{"measure":66,"description":67,"timeFrame":53},"Number of participants with Laboratory abnormalities","Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.",{"measure":69,"timeFrame":70},"Pharmacokinetics: Predose and postdose Serum concentrations of PF-08634404","Up to 37 days after the last dose of treatment",{"measure":72,"timeFrame":70},"Incidence of antidrug antibody against PF-08634404","ALL","18 Years",{"inclusion":76,"exclusion":85,"raw_text":114},[77,78,79,80,81,82,83,84],"Male or female participants aged ≥18 years at the time of informed consent.","Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).","Participants have not received systemic therapy for T-SCLC.","Have at least one measurable lesion as the target lesion based on RECIST v1.1.","Have sufficient tumor tissue from the diagnosis of transformed SCLC available.","Eastern Cooperative Oncology Group performance status of 0 or 1.","Have a minimum life expectancy of \\>12 weeks.","Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.",[86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113],"Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \\\u003C1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.","Leptomeningeal disease","Clinically significant risk of hemorrhage or fistula, including tumor necrosis\u002Fcavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula","History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)","Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)","History of allogeneic organ or hematopoietic stem cell transplantation","Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)","Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:","Prior or current non-infectious pneumonitis requiring systemic therapy","DLCO \\\u003C50% predicted","Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement","Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose","Baseline QTcF \\>480 msec","Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study","Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage","History of significant bleeding disorders or recent major bleeding events","Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding","Active, uncontrolled, or symptomatic infection, including:","Active TB","Active hepatitis B or C","Uncontrolled HIV infection","History of immunodeficiency","Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies","Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation","Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods","Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes","Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)","Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements","Inclusion Criteria:\n\n* Male or female participants aged ≥18 years at the time of informed consent.\n* Histologically or cytologically confirmed T-SCLC. Participant must have had a prior diagnosis of NSCLC with EGFR mutation which transformed to SCLC following the treatment with TKI(s).\n* Participants have not received systemic therapy for T-SCLC.\n* Have at least one measurable lesion as the target lesion based on RECIST v1.1.\n* Have sufficient tumor tissue from the diagnosis of transformed SCLC available.\n* Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Have a minimum life expectancy of \\>12 weeks.\n* Clinical laboratory values at screening within acceptable limits, as defined in the protocol, including: 1) Hematology, 2) Liver function and 3) Renal function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Active or untreated CNS disease, including brain, brainstem, spinal cord, or meningeal metastases. Participants with definitively treated, clinically stable brain metastases may be eligible per protocol criteria. Participants with untreated asymptomatic brain metastases of longest diameter \\\u003C1 cm are permitted if all of the following criteria are met: absence of neurological symptoms, no need for corticosteroids, and brain metastasis has no evidence of edema or hemorrhagic features.\n* Leptomeningeal disease\n* Clinically significant risk of hemorrhage or fistula, including tumor necrosis\u002Fcavitation, invasion or compression of major blood vessels, airways, or critical organs, or risk of tracheoesophageal or pleuroesophageal fistula\n* History of another malignancy (other than NSCLC) within 3 years prior to first dose, except for malignancies with negligible risk of metastasis or death (eg, adequately treated carcinoma in situ, nonmelanoma skin cancer)\n* Unresolved toxicity from prior anti-tumor therapy that has not recovered to Grade ≤1 per NCI CTCAE v5.0 (except alopecia or irreversible toxicities deemed stable)\n* History of allogeneic organ or hematopoietic stem cell transplantation\n* Active autoimmune disease requiring systemic treatment within the past 2 years (Stable replacement therapy and selected low-risk autoimmune conditions are permitted per protocol)\n* Interstitial lung disease (ILD), pneumonitis, or significant pulmonary disease, including:\n\n  * Prior or current non-infectious pneumonitis requiring systemic therapy\n  * DLCO \\\u003C50% predicted\n  * Severe asthma, COPD, pulmonary embolism, or autoimmune lung involvement\n* Uncontrolled or clinically significant cardiovascular, cerebrovascular, metabolic, hepatic, or renal disease within 6 months prior to first dose\n* Baseline QTcF \\>480 msec\n* Major surgery or severe trauma within 4 weeks prior to first dose, or planned major surgery during the study\n* Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage\n* History of significant bleeding disorders or recent major bleeding events\n* Clinically significant gastrointestinal conditions, including recent perforation, fistula, obstruction, or active bleeding\n* Active, uncontrolled, or symptomatic infection, including:\n\n  * Active TB\n  * Active hepatitis B or C\n  * Uncontrolled HIV infection\n* History of immunodeficiency\n* Severe hypersensitivity or allergic reactions to study intervention components or monoclonal antibodies\n* Psychiatric illness or medical condition, including recent suicidal ideation or behavior, that may increase risk or interfere with study participation\n* Prior anti-angiogenic therapy or other prohibited anti-tumor or immunomodulatory therapies per protocol-specified washout periods\n* Use of prohibited concomitant medications, including high-dose systemic corticosteroids, certain anticoagulants, or live vaccines within protocol-specified timeframes\n* Recent participation in another investigational study (within 30 days or 5 half-lives, whichever is longer)\n* Pregnant or breastfeeding participants, or unwillingness to comply with contraception requirements",[116,117],"ADULT","OLDER_ADULT",[119,128,135,143,149,157,166,175,183,191,199,207,216,223,229,238,245,254,262,269,278,286,290,296,305,312,319,327,334,338],{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":124,"geoPoint":125},"City of Hope National Medical Center","Duarte","California","91010","United States",{"lat":126,"lon":127},34.13945,-117.97729,{"facility":129,"status":8,"city":130,"state":122,"zip":131,"country":124,"geoPoint":132},"City of Hope Lennar Foundation Cancer Center","Irvine","92618",{"lat":133,"lon":134},33.66946,-117.82311,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":124,"geoPoint":140},"Hope and Healing Clinical Research","Hinsdale","Illinois","60521",{"lat":141,"lon":142},41.80086,-87.93701,{"facility":136,"status":8,"city":144,"state":138,"zip":145,"country":124,"geoPoint":146},"New Lenox","60451",{"lat":147,"lon":148},41.51198,-87.96561,{"facility":150,"status":8,"city":151,"zip":152,"country":153,"geoPoint":154},"Hospital São Lucas da PUCRS","Porto Alegre","90610-000","Brazil",{"lat":155,"lon":156},-30.03283,-51.23019,{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":162,"geoPoint":163},"Peking Union Medical College Hospital","Beijing","Beijing Municipality","100730","China",{"lat":164,"lon":165},39.9075,116.39723,{"facility":167,"status":168,"city":169,"state":170,"zip":171,"country":162,"geoPoint":172},"Fujian Cancer Hospital","NOT_YET_RECRUITING","Fuzhou","Fujian","350014",{"lat":173,"lon":174},26.06139,119.30611,{"facility":176,"status":168,"city":177,"state":178,"zip":179,"country":162,"geoPoint":180},"Henan Cancer Hospital","Zhengzhou","Henan","450008",{"lat":181,"lon":182},34.75778,113.64861,{"facility":184,"status":8,"city":185,"state":186,"zip":187,"country":162,"geoPoint":188},"Union Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan","Hubei","430048",{"lat":189,"lon":190},30.58333,114.26667,{"facility":192,"status":8,"city":193,"state":194,"zip":195,"country":162,"geoPoint":196},"The First Affiliated Hospital of Nanchang University","Nanchang","Jiangxi","330200",{"lat":197,"lon":198},28.68396,115.85306,{"facility":200,"status":8,"city":201,"state":202,"zip":203,"country":162,"geoPoint":204},"Shanghai Chest Hospital","Shanghai","Shanghai Municipality","200030",{"lat":205,"lon":206},31.22222,121.45806,{"facility":208,"status":168,"city":209,"state":210,"zip":211,"country":212,"geoPoint":213},"Institut Gustave Roussy","Villejuif","VAL DE Marne","94805","France",{"lat":214,"lon":215},48.7939,2.35992,{"facility":217,"status":168,"city":218,"zip":219,"country":212,"geoPoint":220},"Centre Léon Bérard","Lyon","69373",{"lat":221,"lon":222},45.74906,4.84789,{"facility":224,"status":168,"city":225,"country":225,"geoPoint":226},"Queen Mary Hospital","Hong Kong",{"lat":227,"lon":228},22.27832,114.17469,{"facility":230,"status":8,"city":231,"state":232,"zip":233,"country":234,"geoPoint":235},"Sheba Medical Center","Ramat Gan","HA Merkaz","5265601","Israel",{"lat":236,"lon":237},32.08227,34.81065,{"facility":239,"status":8,"city":240,"state":240,"zip":241,"country":234,"geoPoint":242},"Shaare Zedek Medical Center","Jerusalem","9103102",{"lat":243,"lon":244},31.76904,35.21633,{"facility":246,"status":168,"city":247,"state":248,"zip":249,"country":250,"geoPoint":251},"IRCCS Istituto Nazionale dei Tumori Regina Elena","Roma","ROME","00144","Italy",{"lat":252,"lon":253},44.99364,11.10642,{"facility":255,"status":168,"city":256,"state":257,"zip":258,"country":250,"geoPoint":259},"A.O.U. San Luigi Gonzaga","Orbassano","Turin","10043",{"lat":260,"lon":261},45.00547,7.53813,{"facility":263,"status":168,"city":264,"zip":265,"country":250,"geoPoint":266},"Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni","Bergamo","24125",{"lat":267,"lon":268},45.69601,9.66721,{"facility":270,"status":8,"city":271,"state":272,"zip":273,"country":274,"geoPoint":275},"Kansai Medical University Hospital","Hirakata","Osaka","573-1191","Japan",{"lat":276,"lon":277},34.81352,135.64914,{"facility":279,"status":8,"city":280,"state":281,"zip":282,"country":274,"geoPoint":283},"National Cancer Center - Tsukiji Campus","Chūō","Tokyo","104-0045",{"lat":284,"lon":285},35.67004,139.77544,{"facility":287,"status":8,"city":288,"state":281,"zip":289,"country":274},"Japanese Foundation for Cancer Research","Kotoku","135-8550",{"facility":291,"status":8,"city":272,"zip":292,"country":274,"geoPoint":293},"Osaka International Cancer Institute(OICI)","541-8567",{"lat":294,"lon":295},34.69379,135.50107,{"facility":297,"status":168,"city":298,"state":299,"zip":300,"country":301,"geoPoint":302},"Institut Català d'Oncologia - L'Hospitalet","L'Hospitalet de Llobregat","Catalunya [cataluña]","08908","Spain",{"lat":303,"lon":304},41.35967,2.10028,{"facility":306,"status":8,"city":307,"zip":308,"country":301,"geoPoint":309},"Hospital Universitario 12 de Octubre","Madrid","28041",{"lat":310,"lon":311},40.4165,-3.70256,{"facility":313,"status":8,"city":314,"zip":315,"country":301,"geoPoint":316},"Hospital Universitario Virgen Del Rocio","Seville","41013",{"lat":317,"lon":318},37.38283,-5.97317,{"facility":320,"status":8,"city":321,"zip":322,"country":323,"geoPoint":324},"National Cheng Kung University Hospital","Tainan","704302","Taiwan",{"lat":325,"lon":326},22.99083,120.21333,{"facility":328,"status":8,"city":329,"zip":330,"country":323,"geoPoint":331},"National Taiwan University Hospital","Taipei","100",{"lat":332,"lon":333},25.05306,121.52639,{"facility":335,"status":8,"city":329,"zip":336,"country":323,"geoPoint":337},"National Taiwan University Cancer Center (NTUCC)","106",{"lat":332,"lon":333},{"facility":339,"status":8,"city":329,"zip":340,"country":323,"geoPoint":341},"Taipei Veterans General Hospital","11217",{"lat":332,"lon":333},[343],{"name":344,"role":345,"phone":346,"email":347},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[349],{"name":344,"affiliation":13,"role":350},"STUDY_DIRECTOR",[],[353],{"label":354,"url":355},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=C6461014",{"nct_id":4,"conditions":357,"biomarkers":359},[358],"Lung Small Cell Carcinoma",[360],"Soluble Epidermal Growth Factor Receptor",{"nct_id":4,"found":362,"summary":363,"prompt_version":373},true,{"design":364,"status":365,"heading":366,"summary":367,"follow_up":368,"word_count":369,"commitments":370,"compensation":371,"drugs_mentioned":372},"This interventional study plans to enroll 40 adult participants. It is not specified if it is randomized, blinded, or its phase.","completed","Symbiotic-Lung-14: PF-08634404 for Transformed Small Cell Lung Cancer","This study is for adults with Transformed Small Cell Lung Cancer (T-SCLC), a rare type of lung cancer that develops after another type of lung cancer changes. Researchers are studying PF-08634404, a kinase inhibitor, to see how well it works when given alone or with chemotherapy. To join, you must be at least 18 years old, have T-SCLC, and not have received prior treatment for it. You must also have had a previous diagnosis of non-small cell lung cancer (NSCLC) with an EGFR mutation that transformed to SCLC after TKI (tyrosine kinase inhibitor) treatment. The study will measure how many participants respond to the treatment and track any side effects. The study plans to enroll 40 participants, but its current status is unclear.","Participants will be followed for adverse events for up to 90 days after their last dose of treatment. The objective response rate will be assessed from the start of treatment until the first documented complete or partial response, for approximately up to 1 year.",123,"Not specified in the trial record.","Not stated in the trial record.",[36,42],"v2"]