osimertinib
osimertinib: sourced relationships with 1 company · 50 clinical trials tracked · 1 FDA decision.
osimertinib evidence translation
What we can confirm
1 FDA record · 50 tracked trials
What it means
What to watch
Prepared research question
How could osimertinib → AZN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 6 study sponsors
Related indications
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| ASTRAZENECA PLC (AZN) Reported 2015-11-13 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (50)showing 10 most recent
A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer
Primary endpoint: Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Primary endpoint: Grade 3 or dose-limiting toxicities
A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)
Primary endpoint: Objective response rate (ORR)
A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy
Primary endpoint: determine the maximum tolerated dose (MTD) (phase I)
Phase II, Single-arm Multicenter Study of Osimertinib Induction Before Radiotherapy and Maintenance in Chemo-ineligible or Refusing Patients With Stage III, Unresectable NSCLC and EGFR Mutation-positive Tumors
Primary endpoint: PFS (Progression-Free Survival)
A Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of Sacituzumab Tirumotecan in Combination With Osimertinib for Neoadjuvant Treatment in Patients With Resectable Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Primary endpoint: Major Pathological Response (MPR) rate
A Phase 1b Clinical Study of NXP900 in Combination With Osimertinib in Subjects With Advanced, EGFRMut+ Non-Small Cell Lung Cancer
Primary endpoint: Number of patients with treatment related adverse events and/or clinical laboratory abnormalities
A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713
Primary endpoint: Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR)
A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU in Combination With Osimertinib for Patients With Locally Advanced or Metastatic Non- Small Cell Lung Cancer
Primary endpoint: PartA: To evaluate the safety of WSD0922-FU combined with Osimertinib in patients with NSCLC
A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer
Primary endpoint: Stage 1: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with osimertinib?
osimertinib has dated SEC/FDA relationship records for ASTRAZENECA PLC.
How many clinical trials involve osimertinib?
BioSniper tracks 50 clinical trials involving osimertinib.
What is osimertinib's latest FDA decision?
The most recent tracked FDA decision for osimertinib is Approval, dated November 13, 2015.