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 33
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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: 1207 locations

  • Osimertinib with or without Bevacizumab as Initial Treatment for Patients with EGFR-Mutant Lung Cancer

    This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.
    Location: 432 locations

  • Dose-Escalation / Expansion of RMC-4630 and Cobimetinib in Relapsed / Refractory Solid Tumors and RMC-4630 and Osimertinib in EGFR Positive Locally Advanced / Metastatic NSCLC

    The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and cobimetinib in adult participants with relapsed / refractory solid tumors with specific genomic aberrations and to identify the recommended Phase 2 dose (RP2D); and to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of RMC-4630 and osimertinib in adult participants with EGFR mutation-positive locally advanced or metastatic NSCLC.
    Location: 17 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: 13 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: 13 locations

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

    This phase Ib trial studies the side effects and best dose of telaglenastat hydrochloride when given together with osimertinib in treating patients with stage IV non-small cell lung cancer and a mutation in the EGFR gene. Telaglenastat hydrochloride and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
    Location: 10 locations

  • A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

    The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR). Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer. In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer. The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre.
    Location: 9 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: 11 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: 9 locations

  • A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants 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 participants with advanced solid tumors likely to express c-Met. Enrollment is closed for the monotherapy arms, Arm A, and Arm D.
    Location: 8 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 (metastatic). 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

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

    This phase II trial studies the effect of osimertinib 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: 4 locations

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

    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

  • 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

  • A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)

    This study will assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
    Location: 3 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

  • 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 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

  • A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    The purpose of this study is to assess the efficacy of the amivantamab and lazertinib combination, compared with osimertinib, in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions [Exon 19del] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).
    Location: 3 locations

  • A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

    This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer
    Location: 2 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: 2 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 (advanced). 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 Study Comparing Savolitinib Plus Osimertinib vs Savolitinib Plus Placebo in Patients With EGFRm+ and MET Amplified Advanced NSCLC

    This study will compare the activity of the combination of savolitinib and osimertinib against the combination of savolitinib with placebo to osimertinib in patients with Epidermal Growth Factor Receptor Mutation Positive and MET amplified, locally advanced or metastatic non-small cell lung cancer who have progressed following treatment with osimertinib.
    Location: City of Hope Comprehensive Cancer Center, Duarte, California


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