Primary completion· ClinicalTrials.gov
Osimertinib and Gefitinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
Osimertinib History and Updates
250 events · 2014 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
23
FDA Approvals
0
Label Revisions
832
Trial Milestones
6
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-09-24Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Osimertinib since 2014, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (36)
2026
- FDA approval (supplemental)Osimertinib FDA supplemental application approved for efficacy· Sep 14, 2026
- Primary completionOsimertinib phase 3 trial reached primary completion· Jul 6, 2026
- Results postedOsimertinib Neoadjuvant Therapy for EGFRm NSCLC Shows High Pathological Response· Jun 5, 2026
- Results postedOsimertinib SMMART-ACT Trial for Advanced Cancers Terminated· Apr 28, 2026
- Primary completionOsimertinib Trial for EGFR-mutant NSCLC Reaches Primary Completion· Mar 31, 2026
- Results postedOsimertinib Alone Shows Superior PFS vs. Bevacizumab Combo in NSCLC Brain Mets· Mar 17, 2026
- Results postedOsimertinib Plus Savolitinib Shows 56.3% ORR in EGFRm+/MET+ NSCLC· Feb 10, 2026
- Results postedTrial results posted: NCT04765059· Jan 13, 2026
- Pivotal publicationOsimertinib Plus Savolitinib: Interim Analysis for Advanced NSCLC in China· Jan 1, 2026
2025
- Primary completionOsimertinib + Savolitinib NSCLC Trial Reaches Primary Completion· Dec 15, 2025
- Primary completionOsimertinib Trial for Advanced NSCLC (EGFR/TP53) Reaches Primary Completion· Nov 1, 2025
- Results postedOsimertinib: Sequential Gefitinib + Blood Test Shows Higher 18-Month PFS in…· Oct 31, 2025
- Results postedOsimertinib Plus Chemo Trial for Uncommon EGFRm NSCLC Shows 75% ORR· Oct 15, 2025
- Primary completionOsimertinib + Savolitinib Phase 3 NSCLC Trial Reaches Primary Completion· Aug 22, 2025
- Results postedOsimertinib + Telaglenastat RP2D Identified for EGFR-Mutated Stage IV NSCLC· Jun 19, 2025
- Primary completionOsimertinib Phase 3 Study for NSCLC Reaches Primary Completion· May 31, 2025
- Results postedOsimertinib Extends PFS to 39.13 Months in Stage III Unresectable NSCLC· Apr 3, 2025
- Results postedOsimertinib Shows No Objective Response in EGFR Exon 20 NSCLC Trial· Feb 11, 2025
- Pivotal publicationOsimertinib plus Chemotherapy Shows Survival in EGFR-Mutated Advanced NSCLC· Jan 1, 2025
- Pivotal publicationOsimertinib: Overall Survival Data Published for EGFR-Mutated Advanced NSCLC· Jan 1, 2025
2024
- Primary completionOsimertinib Plus Chemotherapy Improves NSCLC PFS and OS in Phase 3 Trial· Oct 28, 2024
- Primary completionOsimertinib Shows Superior Pathological Response in Resectable EGFRm NSCLC· Oct 15, 2024
- FDA approval (supplemental)Osimertinib: FDA approves supplemental efficacy application· Sep 25, 2024
- FDA approval (supplemental)Osimertinib: FDA approves supplemental application on efficacy· Feb 16, 2024
- FDA approval (supplemental)Osimertinib supplemental efficacy application approved by FDA· Jan 31, 2024
- Primary completionOsimertinib cut PFS events in stage III NSCLC trial· Jan 5, 2024
- Pivotal publicationOsimertinib Data Published for Stage III EGFR-Mutated NSCLC…· Jan 1, 2024
- Pivotal publicationOsimertinib Compared to Amivantamab Plus Lazertinib in EGFR-Mutated NSCLC…· Jan 1, 2024
2023
- Primary completionOsimertinib Phase 3 Trial Completes in EGFR-Mutated NSCLC· Apr 3, 2023
- Pivotal publicationOsimertinib with or without Chemotherapy for EGFR-Mutated Advanced NSCLC…· Jan 1, 2023
2020
- FDA approval (supplemental)Osimertinib: FDA approved a supplemental application in 2020· Dec 18, 2020
- FDA approval (supplemental)Osimertinib: FDA approves supplemental application for efficacy· Dec 9, 2020
- FDA approval (supplemental)Osimertinib: FDA approves supplemental application for efficacy· May 23, 2020
2018
- FDA approval (supplemental)Osimertinib: FDA approves supplemental efficacy application· Apr 18, 2018
2017
- FDA approval (supplemental)Osimertinib: FDA approves supplemental application for efficacy· Mar 30, 2017
2015
- FDA approvalOsimertinib: FDA approves Tagrisso as a new molecular entity· Nov 13, 2015
Upcoming & expected milestones
Primary completion· ClinicalTrials.gov
Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
Primary completion· ClinicalTrials.gov
A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resect
Primary completion· ClinicalTrials.gov
Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated
Primary completion· ClinicalTrials.gov
A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC
Primary completion· ClinicalTrials.gov
Treatment Strategies and Survival Outcome for Non-small Cell Lung Cancer With Oncogenic Mutation
Primary completion· ClinicalTrials.gov
MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
High-dose Furmonertinib Versus Osimertinib in Advanced EGFRm NSCLC Patients With Brain Metastases
Primary completion· ClinicalTrials.gov
Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Primary completion· ClinicalTrials.gov
Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Primary completion· ClinicalTrials.gov
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The
Primary completion· ClinicalTrials.gov
Osimertinib Plus Chemotherapy vs Osimertinib in EGFRm NSCLC With Persistence Week-3 ctDNA EGFRm After 1L Osimertinib
Primary completion· ClinicalTrials.gov
Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer
Primary completion· ClinicalTrials.gov
Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification
Primary completion· ClinicalTrials.gov
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Primary completion· ClinicalTrials.gov
AFAMOSI: Efficacy and Safety of Afatinib Followed by Osimertinib Compared to Osimertinib in Patients with EGFRmutated/T790M Mutation Negativ
Primary completion· ClinicalTrials.gov
Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Canc
Primary completion· ClinicalTrials.gov
Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSC
Primary completion· ClinicalTrials.gov
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Osimertinib (TAGRISSO) (ROSY-T)
Primary completion· ClinicalTrials.gov
Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cel
Primary completion· ClinicalTrials.gov
Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive
Primary completion· ClinicalTrials.gov
JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung
Primary completion· ClinicalTrials.gov
Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations, NORTH
Primary completion· ClinicalTrials.gov
A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Loc
Primary completion· ClinicalTrials.gov
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
Primary completion· ClinicalTrials.gov
CSF CTC-Capture-Guided EGFR-TKI and Bevacizumab Combination Therapy in EGFR-Mutant Advanced NSCLC
Primary completion· ClinicalTrials.gov
Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Tr
Primary completion· ClinicalTrials.gov
A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers
Primary completion· ClinicalTrials.gov
Boosting Osimertinib Blood Brain Barrier Penetration
Primary completion· ClinicalTrials.gov
Osimertinib and Necitumumab in Treating Patients With EGFR-Mutant Stage IV or Recurrent Non-small Cell Lung Cancer Who Have Progressed on a
Primary completion· ClinicalTrials.gov
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
Primary completion· ClinicalTrials.gov
Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
Primary completion· ClinicalTrials.gov
A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
Primary completion· ClinicalTrials.gov
Tipifarnib and Osimertinib in EGFR-mutated Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or
Primary completion· ClinicalTrials.gov
A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small
Primary completion· ClinicalTrials.gov
A Global Study to Assess the Effects of Osimertinib in Participants With EGFRm Stage IA2-IA3 NSCLC Following Complete Tumour Resection
Primary completion· ClinicalTrials.gov
A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Gr
Primary completion· ClinicalTrials.gov
Osimertinib to Suppress the Progression of GGN(EGFR Mutation-positive)
Primary completion· ClinicalTrials.gov
Osimertinib to Suppress the Progression of Remaining GGN for EGFR Mutation-positive Stage IB-IIIA Lung Adenocarcinoma
Primary completion· ClinicalTrials.gov
Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC
Primary completion· ClinicalTrials.gov
A Study to Investigate Safety and Efficacy of Osimertinib and Amivantamab in Participants With Non-small Cell Lung Cancer With Common Epider
Primary completion· ClinicalTrials.gov
First in Human Study of AZD9592 in Solid Tumors
Primary completion· ClinicalTrials.gov
Minnelide and Osimertinib for the Treatment of Advanced EGFR Mutated Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
A Prospective Study of Pembrolizumab Combining Chemotherapy in Advanced NSCLC Patients With EGFR Exon 21 Point Mutation.
Past events
2026
Primary completion· ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in
Primary completion· ClinicalTrials.gov
A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanc
Trial started· ClinicalTrials.gov
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination W
Primary completion· ClinicalTrials.gov
Whole Genomic Landscape of Advanced EGFR-mutant NSCLC
Primary completion· ClinicalTrials.gov
Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLC
Primary completion· ClinicalTrials.gov
Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for the Treatment of Advanced or Metastatic EGFR-Mutant Non-squamous Non-s
FDA approval (supplemental)· FDA
Sponsor: ASTRAZENECA. Class: Efficacy.
FDA approval (supplemental)· FDA
Sponsor: ASTRAZENECA. Class: Labeling.
Trial started· ClinicalTrials.gov
Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer
Trial started· ClinicalTrials.gov
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Can
Primary completion· ClinicalTrials.gov
A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
Primary completion· ClinicalTrials.gov
Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
Trial started· ClinicalTrials.gov
Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
Primary completion· ClinicalTrials.gov
Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer
Trial started· ClinicalTrials.gov
A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
Trial registered· ClinicalTrials.gov
Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive
Primary completion· ClinicalTrials.gov
To Evaluate the Efficacy/Safety of Osimertinib Prior to CRT and Maintenance of it With Stage III, Unresectable NSCLC With EGFR Mutations
Primary completion· ClinicalTrials.gov
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed
Trial registered· ClinicalTrials.gov
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination W
Trial started· ClinicalTrials.gov
A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mut
Trial started· ClinicalTrials.gov
A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Boosting Osimertinib Blood Brain Barrier Penetration
Trial started· ClinicalTrials.gov
Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination
Primary completion· ClinicalTrials.gov
A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04)
Primary completion· ClinicalTrials.gov
A Phase 2 Study of Osimertinib in Combination With Selumetinib in EGFR Inhibitor naïve Advanced EGFR Mutant Lung Cancer
Primary completion· ClinicalTrials.gov
A Study of the Combination of Osimertinib, Platinum and Etoposide for Patients With Metastatic EGFR Mutant Lung Cancers
Primary completion· ClinicalTrials.gov
Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for the Treatment of Advanced or Metastatic EGFR-Mutant Non-squamous Non-s
Trial started· ClinicalTrials.gov
A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Ca
Trial registered· ClinicalTrials.gov
A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Intra-pemetrexed Plus Third-generation Small Molecule TKI Drugs (e.g. 'Osimertinib') Versus Third-generation Small Molecule TKI Drugs Alone
Primary completion· ClinicalTrials.gov
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed
Trial registered· ClinicalTrials.gov
A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Ca
Trial registered· ClinicalTrials.gov
A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mut
Primary completion· ClinicalTrials.gov
Testing the Combination of MLN0128 (TAK-228) and AZD9291 in Advanced EGFR (Epidermal Growth Factor Receptor) Mutation Positive Non-small Cel
Results posted· ClinicalTrials.gov
A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resect
Trial registered· ClinicalTrials.gov
A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
Trial started· ClinicalTrials.gov
A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC
Primary completion· ClinicalTrials.gov
Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge
Trial started· ClinicalTrials.gov
Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
Primary completion· ClinicalTrials.gov
A Study to Evaluate the Efficacy of Osimertinib in Patients With EGFR-sensitive Mutated Non-small Cell Lung Cancer Progression After Receivi
Trial started· ClinicalTrials.gov
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC
Primary completion· ClinicalTrials.gov
Comparing Combinations of Targeted Drugs for Advanced Non-Small Cell Lung Cancer That Has EGFR and MET Gene Changes (A Lung-MAP Treatment Tr
Primary completion· ClinicalTrials.gov
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
Trial registered· ClinicalTrials.gov
Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
Trial registered· ClinicalTrials.gov
Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination
Trial started· ClinicalTrials.gov
Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib
Trial started· ClinicalTrials.gov
Boosting Osimertinib Blood Brain Barrier Penetration
Primary completion· ClinicalTrials.gov
Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients
Results posted· ClinicalTrials.gov
A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Canc
Trial registered· ClinicalTrials.gov
A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients
Trial started· ClinicalTrials.gov
A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
Hippocampus-Protective Radiotherapy Combined With Osimertinib for Symptomatic Brain Metastases in EGFR-Mutated Lung Cancer
Trial started· ClinicalTrials.gov
Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study
Primary completion· ClinicalTrials.gov
Radiation During Osimertinib Treatment: a Safety and Efficacy Cohort Study
Primary completion· ClinicalTrials.gov
A Phase 2 Study of Osimertinib and S-1 in Treatment Resistant EGFR Mutant NSCLC
Primary completion· ClinicalTrials.gov
Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and
Primary completion· ClinicalTrials.gov
Adjuvant Target Therapy Guided by ctDNA-MRD in Patients With EGFR-mutant II-IIIA Non-small Cell Lung Cancer (ECTOP-1022)
Trial started· ClinicalTrials.gov
Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumotecan for Neoadjuvant Treatment in Patients W
Trial registered· ClinicalTrials.gov
Osimertinib Combined With Intracranial SRT for EGFR-Mutant NSCLC With Symptomatic Brain Metastases
Trial registered· ClinicalTrials.gov
Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib
Trial registered· ClinicalTrials.gov
Boosting Osimertinib Blood Brain Barrier Penetration
Results posted· ClinicalTrials.gov
Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases
Primary completion· ClinicalTrials.gov
A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Canc
Trial started· ClinicalTrials.gov
A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC
Primary completion· ClinicalTrials.gov
Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated NSCLC Patients.
Primary completion· ClinicalTrials.gov
Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Acti
Trial started· ClinicalTrials.gov
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Local Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer
Results posted· ClinicalTrials.gov
Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib
Trial started· ClinicalTrials.gov
Zorifertinib With Osimertinib for NSCLC With Meningeal Progression
Trial registered· ClinicalTrials.gov
Local Ablative Therapy to Oligoresidual Metastasis in EGFR Mutated Non-small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC
Trial registered· ClinicalTrials.gov
A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positi
Primary completion· ClinicalTrials.gov
Osimertinib Plus Chemotherapy vs Osimertinib in EGFRm NSCLC With Persistence Week-3 ctDNA EGFRm After 1L Osimertinib
Trial registered· ClinicalTrials.gov
Zorifertinib With Osimertinib for NSCLC With Meningeal Progression
Trial registered· ClinicalTrials.gov
Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients
Primary completion· ClinicalTrials.gov
Prospective Cohort of Locally Advanced and Metastatic Non-Small Cell Lung Cancer Patients With Activating EGFR Mutations
Results posted· ClinicalTrials.gov
A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
Trial registered· ClinicalTrials.gov
Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumotecan for Neoadjuvant Treatment in Patients W
Trial registered· ClinicalTrials.gov
Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification
Trial registered· ClinicalTrials.gov
Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Hippocampus-Protective Radiotherapy Combined With Osimertinib for Symptomatic Brain Metastases in EGFR-Mutated Lung Cancer
Pivotal publication· PubMed
SACHI — Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification
2025
Primary completion· ClinicalTrials.gov
A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients
Primary completion· ClinicalTrials.gov
A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC
Primary completion· ClinicalTrials.gov
SI-B001 Combined With Osimertinib Mesylate Tablets in the Treatment of Recurrent Metastatic Non-small Cell Lung Cancer.
Primary completion· ClinicalTrials.gov
An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study
Trial started· ClinicalTrials.gov
Study of NXP900 With Osimertinib in Subjects With Advanced, EGFR-Mutated Non-Small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases
Trial started· ClinicalTrials.gov
A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC Patients With Positi
Primary completion· ClinicalTrials.gov
Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification
Primary completion· ClinicalTrials.gov
Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer
Primary completion· ClinicalTrials.gov
Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired R
Trial registered· ClinicalTrials.gov
Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC
Trial registered· ClinicalTrials.gov
An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung Cancer
Primary completion· ClinicalTrials.gov
Osimertinib and Abemaciclib in EGFR Mutant Non-Small Cell Lung Cancer After Osimertinib Resistance
Trial registered· ClinicalTrials.gov
A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resect
Trial started· ClinicalTrials.gov
A Study of SYS6010 Combined With Osimertinib Versus Osimertinib Alone as Neoadjuvant Therapy for Patients With EGFR Mutation-positive Resect
Primary completion· ClinicalTrials.gov
Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line T
Trial started· ClinicalTrials.gov
A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Osimertinib Monotherapy or Combination With Chemotherapy for Advanced NSCLC Concurrent EGFR and TP53 Mutations
Primary completion· ClinicalTrials.gov
Emulation of the FLAURA (NCT02296125) Trial Using Specialty Oncology Electronic Health Records Databases
Results posted· ClinicalTrials.gov
Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE)
Primary completion· ClinicalTrials.gov
Neoadjuvant Targeted Therapy in Patients With Resectable EGFR-mutated Lung Squamous Cell Carcinoma
Primary completion· ClinicalTrials.gov
A Phase 2 Study of Osimertinib and S-1 in Treatment Resistant EGFR Mutant NSCLC
Primary completion· ClinicalTrials.gov
Alisertib in Combination With Osimertinib in Metastatic EGFR-mutant Lung Cancer
Trial started· ClinicalTrials.gov
A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC
Results posted· ClinicalTrials.gov
Osimertinib Plus Chemotherapy in Uncommon EGFRm NSCLC
Trial registered· ClinicalTrials.gov
A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC
Trial started· ClinicalTrials.gov
A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC
Trial registered· ClinicalTrials.gov
Primary Tumor Resection Plus Osimertinib in Advanced EGFR-mutant Non-small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Either Osimertinib in Participants With Unresec
Trial started· ClinicalTrials.gov
Primary Tumor Resection Plus Osimertinib in Advanced EGFR-mutant Non-small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification
Trial started· ClinicalTrials.gov
A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as Firs
Trial started· ClinicalTrials.gov
A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chem
Primary completion· ClinicalTrials.gov
A Window of Opportunity Study for Investigating Drug Tolerant Persister (DTP) to Neoadjuvant Osimertinib in Resectable Non-small Cell Lung C
Trial started· ClinicalTrials.gov
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
Trial registered· ClinicalTrials.gov
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
Trial registered· ClinicalTrials.gov
A Study of Osimertinib-based Adaptive Treatment Guided by ctDNA EGFRm+ Monitoring in NSCLC
Primary completion· ClinicalTrials.gov
RC48 Combined With EGFR or HER2 TKI for Locally Advanced or Metastatic NSCLC Patients With HER2 Alterations
Primary completion· ClinicalTrials.gov
TY-9591 in the Patients With EGFR Mutations in Advanced NSCLC With Brain Metastases
Trial registered· ClinicalTrials.gov
A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chem
Trial started· ClinicalTrials.gov
A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Canc
Primary completion· ClinicalTrials.gov
Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
Results posted· ClinicalTrials.gov
Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as Firs
Primary completion· ClinicalTrials.gov
First-line Treatment With Osimertinib in EGFR-mutated Non-small Cell Lung Cancer
Primary completion· ClinicalTrials.gov
Phase III Study of TY-9591 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLETEO)
Trial registered· ClinicalTrials.gov
A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Recept
Primary completion· ClinicalTrials.gov
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
Trial started· ClinicalTrials.gov
Real-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma
Primary completion· ClinicalTrials.gov
Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC
Trial registered· ClinicalTrials.gov
Real-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma
Trial registered· ClinicalTrials.gov
Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients
Trial started· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in N
Results posted· ClinicalTrials.gov
A Global Study to Assess the Effects of Osimertinib Following Chemoradiation in Patients With Stage III Unresectable Non-small Cell Lung Can
Primary completion· ClinicalTrials.gov
A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations
Trial started· ClinicalTrials.gov
Glumetinib Combined With Osimertinib Treatment for Non-Small Cell Lung Cancer Patients
Primary completion· ClinicalTrials.gov
AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain
Primary completion· ClinicalTrials.gov
Osimertinib Combined With Intracranial SRT for EGFR-Mutant NSCLC With Symptomatic Brain Metastases
Results posted· ClinicalTrials.gov
A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway.
Trial started· ClinicalTrials.gov
A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors
Trial registered· ClinicalTrials.gov
A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors
Trial started· ClinicalTrials.gov
Optimal Standard Treatment Selection for Solid Tumor Patients by Biologically-informed Multi-agent System
Trial started· ClinicalTrials.gov
A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advance
Trial registered· ClinicalTrials.gov
A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advance
Primary completion· ClinicalTrials.gov
Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Efficacy and Safety of Glumetinib Combined With Osimertinib Mesylate Versus Platinum-based Doublet Chemotherapy in N
Trial registered· ClinicalTrials.gov
Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLC
Trial registered· ClinicalTrials.gov
Optimal Standard Treatment Selection for Solid Tumor Patients by Biologically-informed Multi-agent System
Results posted· ClinicalTrials.gov
Osimertinib for NSCLC With EGFR Exon 20 Insertion Mutation
Trial started· ClinicalTrials.gov
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Ad
Primary completion· ClinicalTrials.gov
HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-S
Primary completion· ClinicalTrials.gov
MEchanisms of Resistance in EGFR Mutated Nonpretreated Advanced Lung Cancer Receiving OSimErtib
Results posted· ClinicalTrials.gov
Osimertinib (AZD9291) in First-line Locally Advanced or Metastatic NSCLC Patients With EGFR and EGFR T790M
Results posted· ClinicalTrials.gov
Osimertinib and Bevacizumab Versus Osimertinib Alone as Second-line Treatment in Stage IIIb-IVb NSCLC With Confirmed EGFRm and T790M
Pivotal publication· PubMed
FLAURA2 — 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)
Primary completion· ClinicalTrials.gov
Osimertinib, Cetuximab, and Tucatinib for the Treatment of EGFR-Mutant Stage IV or Recurrent Non-small Lung Cell Cancer
Trial started· ClinicalTrials.gov
Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS
Pivotal publication· PubMed
MARIPOSA — A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Trial started· ClinicalTrials.gov
Osimertinib Combined With Savolitinib in the Treatment of NSCLC With Low Copy Number MET Amplification
2024
Primary completion· ClinicalTrials.gov
SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC
Trial registered· ClinicalTrials.gov
Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Canc
Trial registered· ClinicalTrials.gov
A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain
Trial started· ClinicalTrials.gov
Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Canc
Trial registered· ClinicalTrials.gov
A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanc
Trial started· ClinicalTrials.gov
A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain
Primary completion· ClinicalTrials.gov
Osimertinib Plus Bevacizumab in Untreated EGFR Exon21 L858R Mutated NSCLC
Trial started· ClinicalTrials.gov
Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC
Trial registered· ClinicalTrials.gov
Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC
Trial started· ClinicalTrials.gov
A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Loc
Trial registered· ClinicalTrials.gov
Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS
Trial registered· ClinicalTrials.gov
Emulation of the FLAURA (NCT02296125) Trial Using Specialty Oncology Electronic Health Records Databases
Trial registered· ClinicalTrials.gov
A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Loc
Trial started· ClinicalTrials.gov
Emulation of the FLAURA (NCT02296125) Trial Using Specialty Oncology Electronic Health Records Databases
Primary completion· ClinicalTrials.gov
A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
Trial started· ClinicalTrials.gov
A Clinical Study of JMT101 in Combination With Osimertinib Versus Osimertinib Alone as First-Line Treatment for Patients With Locally Advanc
Primary completion· ClinicalTrials.gov
A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resect
Primary completion· ClinicalTrials.gov
Osimertinib Therapy After Resection in High-risk Stage I EGFRm NSCLC (OSTAR)
Trial started· ClinicalTrials.gov
Combination of Vebreltinib and Osimertinib in Patients with EGFR 21 L858R Mutation Advanced NSCLC
Trial started· ClinicalTrials.gov
Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive
Results posted· ClinicalTrials.gov
A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Trial registered· ClinicalTrials.gov
A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Canc
Primary completion· ClinicalTrials.gov
(SYMPHONY) Phase 1/2 Study Targeting EGFR Resistance Mechanisms in NSCLC
Trial started· ClinicalTrials.gov
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in
Trial registered· ClinicalTrials.gov
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Ad
Trial started· ClinicalTrials.gov
AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.