Clinical Trials Using Osimertinib

Clinical trials are research studies that involve people. The clinical trials on this list are studying Osimertinib. All trials on the list are supported by NCI.

NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.

Trials 1-25 of 30
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  • Targeted Therapy Directed by Genetic Testing in Treating Patients with Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

    This phase II MATCH trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor's particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
    Location: 1197 locations

  • Osimertinib with or without Bevacizumab in Treating Patients with EGFR Positive Non-small Cell Lung Cancer and Brain Metastases

    This phase II trial studies how well osimertinib with or without bevacizumab works in treating patients with EGFR positive non-small cell lung cancer that has spread to the brain. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Giving osimertinib with or without bevacizumab may work better in treating patients with non-small cell lung cancer.
    Location: 15 locations

  • Osimertinib and Necitumumab in Treating Patients with EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a Previous EGFR Tyrosine Kinase Inhibitor

    This phase I trial studies the side effects and best dose of necitumumab when given together with osimertinib in treating patients with EGFR-mutant non-small cell lung cancer that is stage IV or has come back (recurrent) and who have progressed on a previous EGFR tyrosine kinase inhibitor. Immunotherapy with monoclonal antibodies, such as necitumumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving necitumumab with osimertinib may be a better treatment for EGFR-mutant non-small cell lung cancer.
    Location: 12 locations

  • Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)

    Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple study treatments.
    Location: 11 locations

  • Osimertinib Alone or with Chemotherapy for EGFR-Mutant Lung Cancers

    This phase II trial studies how well osimertinib alone or with chemotherapy (carboplatin and pemetrexed) works in treating people that have lung cancer which has spread to another part of the body (metastatic) and has a change (mutation) in the EGFR gene. Osimertinib binds to the EGFR protein and blocks its activity, which slows the tumor growth. Carboplatin and pemetrexed work by targeting the processes that tumor cells use to grow and spread. Giving these chemotherapy drugs may slow the production of new tumor cells which researchers believe are resistant to osimertinib.
    Location: 7 locations

  • Dacomitinib and Osimertinib in Treating Patients with Metastatic EGFR Mutant Non-small Cell Lung Cancer

    This phase I trial studies the side effects and best dose of dacomitinib and osimertinib in treating patients with EGFR mutant non-small cell lung cancer that has spread to other places in the body. Dacomitinib and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 7 locations

  • Osimertinib Plus Savolitinib in EGFRm+ / MET+ NSCLC Following Prior Osimertinib

    This study (the SAVANNAH study) will investigate the efficacy of osimertinib in combination with savolitinib in patients with EGFRm+ and MET+, locally advanced or metastatic NSCLC who have progressed following treatment with osimertinib
    Location: 7 locations

  • Dacomitinib with or without Osimertinib in Treating Patients with Metastatic EGFR Mutant Lung Cancers with Disease Progression on Osimertinib

    This early phase I trial studies how well dacomitinib with or without osimertinib works in treating patients EGFR mutant lung cancers that has spread to other places in the body (metastatic) and has progressed after treatment with osimertinib. Dacomitinib and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 7 locations

  • Osimertinib, Carboplatin, Cisplatin, and Etoposide in Treating Patients with Metastatic Non-small Cell Lung Cancer with EGFR, RB1, and P53 Mutations

    Mutations are changes in DNA, the genetic material that serves as the body’s instruction book. Some of genetic mutations result in uncontrolled cellular replication and subsequently tumor formation. This phase I trial studies the side effects of osimertinib, carboplatin, cisplatin, and etoposide in treating patients with EGFR, RB1, and P53 mutant non-small cell lung cancer that has spread to other places in the body. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, cisplatin, or etoposide, 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 osimertinib, carboplatin, cisplatin, and etoposide may work better at treating non-small cell lung cancer.
    Location: 7 locations

  • A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Subjects With Advanced Solid Tumors

    This is a Phase 1 / 1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABBV-399 as monotherapy and in combination with osimertinib, erlotinib, and nivolumab in subjects with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.
    Location: 7 locations

  • Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

    The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.
    Location: 5 locations

  • Osimertinib, Surgery, and Radiation Therapy in Treating Patients with Stage IIIB or IV Non-small Cell Lung Cancer with EGFR Mutations

    This phase II trial studies how well osimertinib, surgery, and radiation therapy work in treating patients with stage IIIB or IV non-small cell lung cancer with EGFR mutations. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving osimertinib, surgery, and radiation therapy may work better at treating non-small cell lung cancer with EGFR mutations.
    Location: 4 locations

  • Niraparib and Osimertinib in Treating Patients with Stage IV EGFR-Mutated Non-small Cell Lung Cancer

    This phase I trial studies the best dose of niraparib when given together with osimertinib in treating patients with stage IV EGFR-mutated non-small cell lung cancer. Niraparib and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Niraparib is a type of drug called a “PARP inhibitor”, which blocks deoxyribonucleic acid (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. Osimertinib is an inhibitor of the epidermal growth factor receptor (EGFR). Osimertinib blocks mutated EGFR, which may cause tumor regression (when tumor starts to shrink) and prevent the spread of cancer.
    Location: 4 locations

  • Osimertinib in Treating Participants with Stage IV Non-Small Cell Lung Cancer with Uncommon EGFR Mutations

    This phase II trial studies how well osimertinib works in treating participants with stage IV non-small cell lung cancer with EGFR mutations. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Osimertinib and Selumetinib in Treating Participants with Stage IV EGFR Mutant Non-Small Cell Lung Cancer

    This phase II trial studies how well osimertinib and selumetinib work in treating participants with stage IV EGFR mutant non-small cell lung cancer. Osimertinib and selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 5 locations

  • Osimertinib and Gefitinib in Treating Patients with EGFR Mutant Stage IV Non-small Cell Lung cancer

    This randomized phase I / II trial studies the side effects and best dose of osimertinib when given together with gefitinib in treating patients with EGFR mutant stage IV non-small cell lung cancer. Osimertinib and gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Osimertinib and Stereotactic Body Radiation Therapy in Treating Patients with EGFR Mutant Advanced Non-small Cell Lung Cancer

    This phase II trial studies the how well osimertinib works when given together with stereotactic body radiation therapy in treating patients with EGFR mutant non-small cell lung cancer that has spread to other places in the body. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving osimertinib and stereotactic body radiation therapy may work better in treating patients with advanced non-small lung cancer.
    Location: 2 locations

  • Osimertinib in Treating Patients with Stage IV EGFR-Mutant Non-small Cell Lung Cancer

    This phase II trial studies how well osimertinib works in treating patients with stage IV non-small cell lung cancer who are positive for EGFR mutations. The EGFR gene produces a protein that helps cells divide. Specific changes or mutations in the genetic information can cause abnormal cell division and lead to lung cancer. Patients who have non-small cell lung cancer with an EGFR gene mutation can be treated by drugs called EGFR tyrosine kinase inhibitors. EGFR tyrosine kinase inhibitors such as osimertinib, may stop (or “inhibit”) the effect of the mutation in the EGFR gene and may stop the growth of tumor cells.
    Location: 2 locations

  • A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Cancer (LAURA)

    A global study to assess the efficacy and safety of osimertinib following chemoradiation in patients with stage III unresectable Epidermal Growth Factor Receptor Mutation Positive non-small cell lung cancer
    Location: 3 locations

  • Osimertinib in Treating Patients with Stage I-IIIA EGFR-mutant Non-small Cell Lung Cancer before Surgery

    This phase II trial studies how well osimertinib works in treating patients with stage I-IIIA EGFR-mutant non-small cell lung cancer before surgery. Osimertinib may stop the growth of tumor cells by blocking mutant EGFR signaling in cancer cells.
    Location: 3 locations

  • Alisertib and Osimertinib for the Treatment of EGFR-Mutated Stage IV Lung Cancer

    This phase I / Ib trial studies the side effects and best dose of alisertib when given together with osimertinib in treating patients with EGFR-mutated stage IV lung cancer. Alisertib may stop the growth of tumor cells by blocking a specific protein (Aurora Kinase A) that researchers believe may be important for the growth of lung cancer. Osimertinib may reduce tumor growth by blocking the action of a certain mutant protein (EGFR). This study may help researchers test the safety of alisertib at different dose levels in combination with osimertinib, and to find out what effects, good and / or bad, it has on EGFR-mutated lung cancer.
    Location: UCSF Medical Center-Mount Zion, San Francisco, California

  • A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed Mesenchymal-epithelial Transition Factor (MET) Amplified Non-small Cell Lung Cancer (NSCLC) (INSIGHT 2)

    This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the MET inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic NSCLC..
    Location: University of Chicago Comprehensive Cancer Center, Chicago, Illinois

  • Glutaminase Inhibitor CB-839 Hydrochloride and Osimertinib in Treating Patients with EGFR-Mutated Stage IV Non-small Cell Lung Cancer

    This phase I / II trial studies the side effects and best dose of glutaminase inhibitor CB-839 hydrochloride, and to see how well it works when given together with osimertinib in treating patients with stage IV non-small cell lung cancer and a mutation in the EGFR gene. Glutaminase inhibitor CB-839 hydrochloride and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 3 locations

  • Osimertinib and Stereotactic Radiosurgery in Treating Patients with Brain Metastases from EGFR-Positive Non-Small-Cell Lung Cancer

    This phase I trial studies the side effects, best dose, and how well osimertinib works when used in combination with stereotactic radiosurgery in treating patients with EGFR-positive non-small cell lung cancer that has spread to the brain. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Giving osimertinib with stereotactic radiosurgery may work better in treating patients with brain metastases from EGFR-positive non-small cell lung cancer.
    Location: Case Comprehensive Cancer Center, Cleveland, Ohio

  • Necitumumab and Trastuzumab in Combination with Osimertinib for the Treatment of Refractory EGFR-Mutated Stage IV Non-small Cell Lung Cancer

    This phase Ib / II trial identifies the safety, best dose and activity of trastuzumab, necitumumab in combination with osimertinib for the treatment of stage IV non-small cell lung cancer that is EGFR-mutated, resistant to osimertinib, and has not responded to previous treatment (refractory). Trastuzumab and necitumumab are a form of “targeted therapy” because they work by attaching themselves to specific molecules (receptors) on the surface of cancer cells, known as HER2 and EGFR, respectively. When they attach to these receptors, the signals that tell the cells to grow are blocked, and therefore tumor may stop growing. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving trastuzumab and necitumumab in combination with osimertinib may work better than osimertinib alone in treating patients with refractory stage IV EGFR-mutated non-small cell lung cancer.
    Location: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California


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