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OncoMatch/Clinical Trials/Osimertinib

Third-generation EGFR inhibitor

Osimertinib (AZD9291) Clinical Trials

31 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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Lung Cancer — Non-Small Cell (NSCLC)
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 3

EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

Region Skane

Phase 3

A 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 Cancer

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Additional trials

More Osimertinib trials

See all 31 →
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 sitesNCT03191149Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 ChangePhase 2338 US sitesNCT04410796Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung CancersPhase 218 US sitesNCT06618287A 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 sitesNCT05785741A Study of DB-1310 in Advanced/Metastatic Solid TumorsPhase 1/Phase 213 US sitesNCT04486833Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on OsimertinibPhase 1/Phase 210 US sitesNCT04665206Study to Evaluate VT3989 in Patients With Metastatic Solid TumorsPhase 1/Phase 29 US sitesNCT06014827Biologically 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
Phase 1
12 international trials (no US sites)
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 3NCT07079475Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)Phase 1/Phase 2NCT06574347Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.Phase 2NCT06383728Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell CarcinomaPhase 2NCT05948813TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain MetastasesPhase 2NCT05686434Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)Phase 2NCT05528458Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung AdenocarcinomaPhase 2NCT07375316A 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 2NCT05281406Additional 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 2NCT06109558The Efficacy and Safety of LMV-12 Combined With Osimertinib in NSCLCPhase 1/Phase 2NCT05011487Neoadjuvant Osimertinib + Chemotherapy for EGFR-mutant Stage III NSCLCPhase 2NCT04322890Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic MutationPhase 2
Cancer types studied
Key biomarker pages

How OncoMatch helps you find Osimertinib trials

01

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OncoMatch reads the eligibility criteria for every Osimertinib trial and extracts structured requirements — biomarkers, stage, prior therapy — from protocol text.

02

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03

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Each trial shows which criteria you meet, which you don't, and which need more information. Bring the shortlist to your oncologist.

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