[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transformed-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transformed-small-cell-lung-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100604710","phase-1-lurbinectedin-with-osimertinib-in-transformed-small-cell-lung-cancer-100604710",false,"NCT07153055","Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer","Phase I\u002FII Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer","LOTS","Inclusion Criteria\n\n1. ≥ 18 years old at the time of informed consent.\n2. Ability to provide written informed consent and HIPAA authorization.\n3. Must have a histologically or cytologically confirmed transformation to small cell lung carcinoma\u002Fcancer.\n4. Must have an initial diagnosis of EGFR altered (EGFR-mutated) non-small cell lung cancer and received EGFR targeted therapy (TKI) osimertinib, and does not demonstrate evidence of acquired molecular underpinnings (i.e., presence of a MET amplification \\>6 copies or EGFR C797S) resulting in progression on osimertinib, aside from histologic transformation to small cell lung cancer. Interruptions of osimertinib prior to enrollment on study is permitted.\n\n   Note: Tissue specimens from archival tissue are encouraged but not required for enrollment.\n5. Patients who have received platinum (cisplatin or carboplatin)\u002Fetoposide after histologic transformation are permitted on study. Receipt of last cycle of therapy should be at least 3 weeks prior to initiation of treatment on study. Last exposure to immunotherapy such as anti-PD-L1 should be at least four weeks from treatment to initiation of treatment on study. Patients who decline to receive platinum\u002Fetoposide after SCLC transformation, for personal preferences or considered medical ineligible for this regimen, may be considered for this study, subject to investigator discretion.\n6. Must have measurable disease per RECIST (version 1.1).\n7. ECOG performance status ≤ 2.\n8. Adequate laboratory functions on baseline testing within 21 days of enrollment, as defined as:\n\n   a. Hematologic parameters: i. Absolute neutrophil count (ANC) ≥ 1.5x109\u002FL ii. Platelet count (Plt) ≥ 100x109\u002FL b. Hepatic parameters: i. Total bilirubin ≤ 1.5x upper limit of normal (ULN); for patients with suspected\u002Fdocumented Gilbert's syndrome, total bilirubin ≤ 3x ULN.\n\n   ii. AST ≤ 3x ULN. iii. ALT ≤ 3x ULN. c. Renal parameters: i. Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR, calculated per institutional standards) should be \\> 30 mL\u002Fmin.\n9. Women of childbearing potential must have a negative pregnancy test within 21 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:\n\n   i. Has achieved menarche at some point; or ii. Has not undergone a hysterectomy or bilateral oophorectomy; or iii. 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).\n10. Women of childbearing potential and men with any partners of child-bearing potential must agree to use 2 forms of effective contraception throughout the study and for 6 months after the last study treatment.\n\n    Note: Acceptable methods of birth control include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).\n11. Male subjects must agree to refrain from donating sperm during the study and for 6 months after the last study treatment. Female subjects must agree to refrain from donating eggs during the study and for 6 months after the last study treatment.\n\nExclusion Criteria\n\n1. Patients who have tumors harboring EGFR exon 20 insertion alterations, EGFR C797S, or known mechanisms of resistance to osimertinib (i.e., MET amplification) aside from histologic transformation to SCLC.\n2. Patients who are pregnant (treatment can cause fetal harm) and\u002For breastfeeding.\n3. Symptomatic or unstable brain metastases, requiring \\> 2 mg dexamethasone orally daily, or received palliative radiation to the CNS within 2 weeks of enrollment.\n4. Patients with known history of interstitial lung disease (ILD) or pneumonitis (\\> grade 1) or ILD\u002Fpneumonitis (\\> grade 1) related to antineoplastic drug treatment.\n5. Prior history of documented Stephen Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme major (EMM), or aplastic anemia on osimertinib.\n6. History of congenital long QTc syndrome or mean resting QTc \\>500 msec at screening with two replicated EKGs at baseline screening for the study.\n7. History of ongoing unstable or uncontrolled cardiac conditions, including documented cardiomyopathy or symptomatic congestive heart failure (defined as New York Heart Association (NYHA) class III or IV).\n8. Prior history of documented severe allergic or anaphylactic reaction to osimertinib.\n9. Prior history of documented aplastic anemia with osimertinib.\n10. Prior history of documented allergic or anaphylactic reactions to inactive ingredients of lurbinectedin, including sucrose, lactic acid, and sodium hydroxide.","ALL","18 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This open-label, Phase I\u002FII trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).",[28,29],"Small Cell Lung Cancer ( SCLC )","Transformed Small Cell Lung Cancer",[31],"EGFR mutations","RECRUITING","2026-06-16",{"date":35,"type":36},"2026-06-18","ACTUAL",{"date":38,"type":21},"2026-08",{"date":40,"type":21},"2029-10",{"name":42,"class":43},"Misty Shields","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100629562","phase-2-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-100629562","NCT07476287","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","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",{"count":53,"type":21},40,[25],"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.",[57,28,29,58,59,60],"Small Cell Lung Cancer","Lung Neoplasms","Carcinoma, Small Cell Lung","Small Cell Cancer Of The Lung",[29,57],"2026-06-03",{"date":64,"type":36},"2026-06-04",{"date":66,"type":21},"2026-05-15",{"date":68,"type":21},"2031-03-19",{"name":70,"class":71},"Pfizer","INDUSTRY",12]