Osimertinib (AZD9291) Clinical Trials

46 recruiting trials·AstraZeneca

Osimertinib (Tagrisso, AZD9291) is a third-generation, CNS-penetrant EGFR tyrosine kinase inhibitor that selectively targets EGFR-sensitizing mutations (exon 19 deletions, L858R) and the T790M resistance mutation, while sparing wild-type EGFR. It is the established first-line standard of care for advanced EGFR-mutant NSCLC (FLAURA) and approved adjuvant therapy after resection (ADAURA). The osimertinib plus platinum-based chemotherapy combination (FLAURA2) received FDA approval in 2024 for first-line use in patients without contraindications to chemotherapy, broadening the standard-of-care options. The active trial landscape focuses on combination strategies — pairing osimertinib with antibody-drug conjugates (Dato-DXd, SKB264) and novel agents for treatment-naive and post-progression settings. Eligibility universally requires confirmed EGFR-sensitizing mutation; resistance-setting trials typically require prior osimertinib.

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Top recruiting

Recruiting Osimertinib trials

Ranked by phase and US site count. Filter by your biomarker profile →

Phase 3603 US sites

Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer

National Cancer Institute (NCI)

Phase 3463 US sites

Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-Small Cell Lung Cancer

NRG Oncology

Phase 334 US sites

Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer

AstraZeneca

Phase 334 US sites

A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

AstraZeneca

Phase 313 US sites

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

AstraZeneca

Phase 2/Phase 311 US sites

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer

AbbVie

Additional trials

More Osimertinib trials

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Phase 2

NCT05642572Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Trial)Phase 2446 US sites NCT03191149Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 ChangePhase 2338 US sites NCT04410796Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung CancersPhase 218 US sites NCT06618287A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid TumorsPhase 1/Phase 213 US sites NCT05785741A Study of DB-1310 in Advanced/Metastatic Solid TumorsPhase 1/Phase 213 US sites NCT04486833Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on OsimertinibPhase 1/Phase 210 US sites NCT04665206Study to Evaluate VT3989 in Patients With Metastatic Solid TumorsPhase 1/Phase 29 US sites NCT03586453Osimertinib In EGFR Mutant Lung CancerPhase 22 US sites NCT06014827Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung CarcinomaPhase 22 US sites

15 international trials (no US sites)

NCT06486142EGFR-mutated Lung Cancer in Randomized Investigator-Initiated StudyPhase 3 NCT06670196A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung CancerPhase 3 NCT06838273A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung CancerPhase 3 NCT06829459A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in Non-Small Cell Lung Cancer Patients After Resistance to EGFR-TKIsPhase 3 NCT07079475Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)Phase 1/Phase 2 NCT06574347Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.Phase 2 NCT06383728Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell CarcinomaPhase 2 NCT05948813TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain MetastasesPhase 2 NCT05686434Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)Phase 2 NCT05528458Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung AdenocarcinomaPhase 2 NCT07375316A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positvie ctDNA After lead-in Osimertinib MonotherapyPhase 2 NCT05281406Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)Phase 2 NCT06109558The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLCPhase 1/Phase 2 NCT05011487Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLCPhase 2 NCT04322890Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic MutationPhase 2

Cancer types studied

Lung Cancer — Non-Small Cell (NSCLC)

Key biomarker pages

EGFR Lung Cancer — Non-Small Cell (NSCLC)

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Lung Cancer — Non-Small Cell (NSCLC) trials →