Osimertinib clinical trials, in English

This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT03191149 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

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.

NCT04181060 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer.

NCT04410796 · Official ClinicalTrials.gov record · Memorial Sloan Kettering Cancer Center

The purpose of this randomly assigned study is to determine the safety and how well it works of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene and is the first systemic gene therapy for cancer.

NCT04486833 · Official ClinicalTrials.gov record · Genprex, Inc.

This phase Ib trial is to find out the best dose, possible benefits and/or side effects of osimertinib and tegavivint as first-line therapy in treating patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (metastatic). Osimertinib and tegavivint may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT04780568 · Official ClinicalTrials.gov record · Ohio State University Comprehensive Cancer Center

This phase II trial tests how well biologically guided radiation therapy (BgRT) and stereotactic body radiation therapy (SBRT) with osimertinib works for the treatment of EGFR positive non-small cell lung carcinoma that has spread from where it first started (primary site) to a limited number of anatomic sites (oligoprogressive). BgRT is radiation that uses specialized imaging to during treatment to target the active tumor and direct radiation to tumors in order to kill and shrink tumor cells.

NCT06014827 · Official ClinicalTrials.gov record · City of Hope Medical Center

Lung cancer (LC) is the tumor responsible for the highest mortality worldwide. Lung adenocarcinoma is the major subtype of lung cancer and represents the deadliest human cancer, affecting current-, ex-, and even non-smokers.

NCT06068049 · Official ClinicalTrials.gov record · AstraZeneca

A prospective ,multicenter ,non-treatment ,real-world study observing changes in molecular markers after three weeks of osimertinib targeted therapy in EGFRm NSCLC

NCT06422546 · Official ClinicalTrials.gov record · Beijing Cancer Prevention & Treatment Society

This study wants to measure the safety, tolerability, drug levels, and preliminary how well it works of BMS-986507 combinations in adult participants with advanced solid tumors.

NCT06618287 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This is a multi-center , open-label, phase 1/2 study to measure the safety, how well it works, and pharmacokinetic (PK) characteristics of HYP-6589 in this drug alone in advanced solid tumors and combination with tyrosine kinase inhibitors in patients with advanced NSCLC with target-driven gene positivity.

NCT06712680 · Official ClinicalTrials.gov record · Sichuan Huiyu Pharmaceutical Co., Ltd

The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC. The researchers will also look at how the study intervention impacts participants' quality of life.

NCT06741085 · Official ClinicalTrials.gov record · Memorial Sloan Kettering Cancer Center

This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.

NCT06868485 · Official ClinicalTrials.gov record · Wayshine Biopharm, Inc.

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. this study wants to assess side effects and change in disease activity "when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy).

NCT07005102 · Official ClinicalTrials.gov record · AbbVie

The objective of this study is to build a prospective cohort in patients with locally advanced or metastatic NSCLC with common EGFR mutations. In NPM-002, there will be standardized data collection at baseline, on-treatment and at discontinuation of therapy.

NCT07028489 · Official ClinicalTrials.gov record · N-Power Medicine

This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment.

NCT07079475 · Official ClinicalTrials.gov record · Dizal Pharmaceuticals

A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy

NCT07100080 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This open-label, Phase I/II 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).

NCT07153055 · Official ClinicalTrials.gov record · Misty Shields

Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. this study wants to assess side effects and change in disease activity of telisotuzumab adizutecan as a this drug alone or in combination with osimertinib compared to standard of care (SOC).

NCT07155187 · Official ClinicalTrials.gov record · AbbVie

Global, Phase 3, randomly assigned, multicenter, open-label study evaluating the how well it works and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. you would be randomly assigned in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.

NCT07185997 · Official ClinicalTrials.gov record · ArriVent BioPharma, Inc.

This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation

NCT07206498 · Official ClinicalTrials.gov record · Wayshine Biopharm, Inc.

This study is designed as a multi-cohort trial based on various patient biomarkers study with the potential to include new study treatment in the future. EGFR-sensitive mutation-positive patients with distant recurrence after adjuvant osimertinib treatment for EGFRm resectable SIB-IIIA NSCLC and scheduled to receive osimertinib plus chemotherapy will be enrolled in cohort 1.

NCT07279935 · Official ClinicalTrials.gov record · AstraZeneca

This study wants to measure how well it works and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).

NCT07295821 · Official ClinicalTrials.gov record · AstraZeneca

This is a cross-sectional, non-treatment qualitative study using individual interviews to investigate determinants of persistence with 3rd generation EGFR-TKI osimertinib as adjuvant therapy among patients with early-stage NSCLC in China. Approximately 100 you would be enrolled, comprising around 85 patients and 15 physicians.

NCT07542210 · Official ClinicalTrials.gov record · AstraZeneca

This study wants to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy

NCT07680790 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

This single-site, biomarker-enriched, randomly assigned Phase II study will evaluate osimertinib with or without cyclosporine A (CsA) in metastatic epidermal growth factor receptor (EGFR )-mutant non-small cell lung cancer (NSCLC) \[exon 19 deletion or L858R\]. All consented, baseline circulating tumor DNA (ctDNA)-positive patients receive a 3-week osimertinib run-in; those with persistent ctDNA ("shedders") are randomly assigned 1:1 to continue osimertinib or osimertinib+CsA.

NCT07874490 · Official ClinicalTrials.gov record · NYU Langone Health

The goal of this clinical trial is to learn whether adding stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (SRT), delivered on a linear accelerator (LINAC), to osimertinib improves control of brain metastases in adults with stage IV non-small cell lung cancer (NSCLC) carrying a sensitizing EGFR mutation (exon 19 deletion or exon 21 L858R) whose brain metastases cause neurological symptoms (present at diagnosis or arising during osimertinib treatment). The main questions it aims to answer are: * What proportion of participants achieve an intracranial objective response (complete or partial response by RANO-BM criteria)?

NCT07911449 · Official ClinicalTrials.gov record · Cho Ray Hospital