{"id":"tyrosine-kinase-inhibitor-tki","rwe":[{"pmid":"41863042","year":"2026","title":"Coronavirus disease 2019 infection reduces EGFR-TKI efficacy in non-small cell lung carcinoma: Real-world evidence from a multicenter propensity-matched cohort.","journal":"International journal of cancer"},{"pmid":"41862776","year":"2026","title":"Real-World Outcomes of Sequential Afatinib and Osimertinib Versus Afatinib and Chemotherapy in EGFR-Mutant NSCLC: Taiwan Multicenter GIANT Study.","journal":"Targeted oncology"},{"pmid":"41847630","year":"2026","title":"Health Disparities in Acute Myeloid Leukemia Patients Undergoing Treatment with Tyrosine Kinase Inhibitor (TKI) Therapy Targeting FLT3, IDH1, or IDH2.","journal":"Blood and lymphatic cancer : targets and therapy"},{"pmid":"41686417","year":"2026","title":"Real-World Clinical Outcomes and Treatment Patterns in Advanced/Metastatic EGFR-Mutant NSCLC After Progression on First-Line Osimertinib for French Patients.","journal":"Advances in therapy"},{"pmid":"41681745","year":"2026","title":"Assessment of Meet-URO and CANLPH Prognostic Models in Metastatic RCC: Insights from a Single-Institution Cohort Predominantly Treated with TKIs.","journal":"Diagnostics (Basel, Switzerland)"}],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT04027647","NCT04541706","NCT05286528","NCT02130557","NCT06282991","NCT04979988","NCT04362072","NCT00493181","NCT03538717","NCT05534789","NCT02906696","NCT04076787","NCT05166135","NCT02315755","NCT02789137","NCT05012865","NCT06724536","NCT01649180","NCT01265810","NCT03140176","NCT02921477","NCT04647110","NCT04375150"],"aliases":[],"patents":[],"pricing":[],"allNames":"tyrosine kinase inhibitor (tki)","offLabel":[],"timeline":[{"date":"2011","type":"neutral","milestone":"Phase 2 Initiated","description":"Phase 2 trial (Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients) — Leukemia"},{"date":"2015","type":"neutral","milestone":"Phase 3 Initiated","description":"Phase 3 trial (Caphosol in Oral Mucositis Due to Targeted Therapy) — Oral Complaints"},{"date":"2022","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung) — Advanced Non-Small Cell Lung Cancer"},{"date":"2023","type":"neutral","milestone":"Phase 1 Initiated","description":"Phase 1 trial (Study for the Use of TKIs for Treatment of Cognitive Decline Due to Degenerative Dementias) — Mild Cognitive Impairment"}],"aiSummary":"Tyrosine kinase inhibitors (TKIs) are a class of medications used to treat various types of cancer, including non-small cell lung cancer, HER2-positive breast cancer, brain metastases, myelofibrosis, and hepatocellular carcinoma. Examples of TKIs include Crizotinib, which is specifically used to treat ALK-rearranged advanced squamous cell carcinoma.","brandName":"Tyrosine kinase inhibitor (TKI)","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Small molecule","drugClass":"TKIs","explanation":"","oneSentence":"TKIs","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"tyrosine-kinase-inhibitor-tki","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Renal Cell Carcinoma (RCC)","phase":"preclinical","trialId":"","patients":null,"diseaseId":"oncology","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04027647","phase":"Phase 2","title":"Phase 2 Study of Dacomitinib in NSCLC","status":"Active Not Recruiting","sponsor":"National Cancer Centre, Singapore","isPivotal":false,"enrollment":118,"indication":"NSCLC Stage IIIB","completionDate":"2026-03","primaryEndpoint":"This is a multi-national, multi-centre, single-arm, open-label, Phase 2 clinical study of the efficacy and safety of first-line treatment with dacomitinib, with or without dose titration, in subjects "},{"nctId":"NCT04541706","phase":"Phase 4","title":"Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":100,"indication":"Advanced Non-Small Cell Lung Cancer","completionDate":"2022-07","primaryEndpoint":"Lorlatinib is a third-generation, oral, reversible, ATP-competitive, macrocyclic TKI of ALK and ROS1."},{"nctId":"NCT05286528","phase":"N/A","title":"Study to Evaluate Chronic Myeloid Leukemia Treatment Landscape and Real-life Treatment Outcomes in H","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1484,"indication":"Chronic Myeloid Leukaemia","completionDate":"2022-01","primaryEndpoint":"The objectives of this study are to describe patient demographics, clinical and disease characteristics and treatment patterns of Chronic Lymphoid Leukaemia (CML) in Hungary."},{"nctId":"NCT02130557","phase":"Phase 3","title":"A Multicenter Phase 3, Open-Label Study of Bosutinib Versus Imatinib in Adult Patients With Newly Di","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":536,"indication":"Leukemia, Myelogenous, Chronic, Breakpoint Cluster Region-Abelson Proto-oncogene","completionDate":"2016-08","primaryEndpoint":"Phase 3, 2-arm, randomized, open label trial."},{"nctId":"NCT06282991","phase":"N/A","title":"A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Con","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":73,"indication":"Non-Small Cell Lung Carcinoma","completionDate":"2021-01","primaryEndpoint":"The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled."},{"nctId":"NCT04979988","phase":"N/A","title":"Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC J","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":51,"indication":"ALK-positive Non-small-cell Lung Cancer","completionDate":"2021-12","primaryEndpoint":"To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failur"},{"nctId":"NCT04362072","phase":"Phase 4","title":"Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":71,"indication":"Carcinoma","completionDate":"2024-05","primaryEndpoint":"The purpose of this clinical trial is to learn whether the study medicine (called lorlatinib) is safe and effective for the treatment of non-small cell lung cancer that is caused by an abnormal anapla"},{"nctId":"NCT00493181","phase":"Phase 2","title":"Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients","status":"Completed","sponsor":"M.D. Anderson Cancer Center","isPivotal":false,"enrollment":8,"indication":"Leukemia","completionDate":"2011-01","primaryEndpoint":"The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet counts while recei"},{"nctId":"NCT03538717","phase":"N/A","title":"\"Retrospective Study to Identify Clinical Factors Related to a High Benefit of Axitinib in mRCC\"","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":157,"indication":"Carcinoma, Renal Cell","completionDate":"2019-03","primaryEndpoint":"Retrospective study to collect data from Patients with advanced/metastatic renal cell carcinoma previously treated with Axitinib under standard clinical practice, to describe the clinical profile of t"},{"nctId":"NCT05534789","phase":"N/A","title":"Treatment Patterns and Clinical Outcomes Among Patients With Advanced Renal Cell Carcinoma (aRCC) Re","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":106,"indication":"Carcinoma, Renal Cell","completionDate":"2023-12","primaryEndpoint":"The purpose of this study is to learn about the treatments used in for advanced renal cell carcinoma as well as effectiveness of these treatments in the real world."},{"nctId":"NCT02906696","phase":"Phase 2","title":"Bosutinib in Treating Patients With Chronic Myeloid Leukemia in Chronic Phase After Frontline TKI Fa","status":"Terminated","sponsor":"M.D. Anderson Cancer Center","isPivotal":false,"enrollment":8,"indication":"Blasts Under 15 Percent of Bone Marrow Nucleated Cells","completionDate":"2019-08","primaryEndpoint":"This phase II trial studies how well bosutinib works in treating patients with chronic myeloid leukemia in chronic phase after frontline tyrosine kinase inhibitor (TKI) failure."},{"nctId":"NCT04076787","phase":"N/A","title":"Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":1769,"indication":"Metastatic Renal Cell Carcinoma","completionDate":"2018-09","primaryEndpoint":"This is a retrospective, longitudinal cohort study that assessed clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) who received sunitinib as first-line treatment."},{"nctId":"NCT05166135","phase":"N/A","title":"Latin American Real-world Study in Acute Leukemia","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":589,"indication":"Acute Myeloid Leukemia","completionDate":"2022-11","primaryEndpoint":"The objective of the study is to describe the current epidemiology, treatment patterns, outcomes and healthcare resource use of adult patients diagnosed with relapsed/refractory (R/R) B-cell ALL and d"},{"nctId":"NCT02315755","phase":"N/A","title":"Observational Study Evaluating The Efficacy And Effects On Quality Of Life Of Targeted Treatments Fo","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":102,"indication":"Renal Cell Carcinoma","completionDate":"2017-11","primaryEndpoint":"Metastatic renal cell carcinoma (mRCC) is the most common malignant tumour of the kidneys."},{"nctId":"NCT02789137","phase":"N/A","title":"Study On Fatigue- And Hand-Foot Syndrome-Related Quality Of Life In Patients With Metastatic Renal C","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":111,"indication":"Metastatic Renal Cell Carcinoma","completionDate":"2020-10","primaryEndpoint":"The purpose of this study is to know about the quality of life of patients with metastatic renal cell carcinoma who are being treated with sunitinib, pazopanib or sorafenib, and who suffer from fatigu"},{"nctId":"NCT05012865","phase":"N/A","title":"Current Treatment Outcomes in Japanese RCC Patients Treated With Avelumab Plus Axitinib as First-lin","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":48,"indication":"Renal Cell Carcinoma","completionDate":"2022-01","primaryEndpoint":"This study is a multicenter, non-interventional, retrospective, medical chart review of patients with metastatic renal cell cancer(mRCC) treated with avelumab plus axitinib as a first-line therapy in "},{"nctId":"NCT06724536","phase":"N/A","title":"Interaction Between Gut Microbiota and TKIs in Defining the Clinical Outcomes of Patients With CML","status":"Recruiting","sponsor":"Carmen Fava","isPivotal":false,"enrollment":100,"indication":"Leukemia,Myeloid, Chronic","completionDate":"2026-10","primaryEndpoint":"Gut microbiome (GM) is acquiring increasing importance in human health and disease."},{"nctId":"NCT01649180","phase":"Phase 2","title":"NEXT: Subsequent Exposure to Tyrosine Kinase Inhibition at Recurrence After Adjuvant Therapy in Rena","status":"Terminated","sponsor":"PrECOG, LLC.","isPivotal":false,"enrollment":3,"indication":"Renal Cell Carcinoma","completionDate":"2016-01","primaryEndpoint":"The purpose of this study is to see how well the study drug, axitinib, helps control renal (kidney) cancer that has come back (recurrent) or spread (metastatic)."},{"nctId":"NCT01265810","phase":"Phase 3","title":"Caphosol in Oral Mucositis Due to Targeted Therapy","status":"Completed","sponsor":"Impaqtt Foundation","isPivotal":false,"enrollment":64,"indication":"Oral Complaints","completionDate":"2015-08","primaryEndpoint":"Targeted therapies such as multi-targeted tyrosine kinase inhibitors (TKI) and mammalian target of rapamycin inhibitors (mTORI) in renal cell carcinoma (RCC), demonstrate a high level of efficacy with"},{"nctId":"NCT03140176","phase":"N/A","title":"Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as Fi","status":"Terminated","sponsor":"Pfizer","isPivotal":false,"enrollment":77,"indication":"Metastatic Renal Cell Carcinoma","completionDate":"2022-01","primaryEndpoint":"OPTIMISE is designed to provide knowledge regarding the use of Sunitinib as 1st line treatment and 2nd line treatment selected (Sunitinib-different sequence) with respect to efficacy outcomes, adverse"},{"nctId":"NCT02921477","phase":"Phase 1","title":"Study for the Use of TKIs for Treatment of Cognitive Decline Due to Degenerative Dementias","status":"Unknown","sponsor":"Neurological Associates of West Los Angeles","isPivotal":false,"enrollment":150,"indication":"Mild Cognitive Impairment","completionDate":"2023-12","primaryEndpoint":"The present study is designed as an open label study of patients with mild cognitive impairment or dementia to evaluate longer term tolerability and potential efficacy of tyrosine kinase inhibitors."},{"nctId":"NCT04647110","phase":"N/A","title":"Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":549,"indication":"ALK-positive NSCLC","completionDate":"2021-03","primaryEndpoint":"This study aims to explore for the first time how the different ALK TKIs have been sequenced in real-world clinical practice and with which outcomes for Swedish lung cancer patients"},{"nctId":"NCT04375150","phase":"N/A","title":"Master Protocol to Study Treatment Patterns, Medication Adherence, Health and Economic Outcomes and ","status":"Completed","sponsor":"Pfizer","isPivotal":false,"enrollment":355,"indication":"Renal Cell Carcinoma (RCC)","completionDate":"2022-10","primaryEndpoint":"The study aims to assess treatment patterns and outcomes in advanced RCC patients in real world clinical practices across various real world databases."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"chemblId":"CHEMBL4536936"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Oncology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":4,"trialStats":{"total":2,"withResults":1},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}