69 completed, 65 recruiting, 63 active not recruiting, 42 unknown. 159 Phase 2, 87 Phase 1, 46 Phase 3, 5 Not applicable, 3 Phase 4.
Follow osimertinib: new trials by email Literature Review of osimertinib trials Research Report on osimertinib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer Lurbinectedin, Osimertinib - Small Cell Lung Cancer ( SCLC ), Transformed Small Cell Lung Cancer | Phase 1 / Phase 2 | Recruiting | Misty Shields | 16 | 2027-01-01 | 2026-10-15 |
| ASKC202 Plus Limertinib as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC ASKC202, ASKC202 placebo, osimertinib placebo - EGFR Activating Mutation, Non-Squamous Non-Small Cell Lung Cancer (NSCLC) | Phase 3 | Not yet recruiting | Jiangsu Aosaikang Pharmaceutical Co., Ltd. | 425 | 2026-10-30 | 2026-10-27 |
| Osimertinib and Cyclosporine A to Enhance Antitumor Efficacy in NSCLC Osimertinib, Cyclosporine A (CsA), ctDNA Biopsy Panel - Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor | Phase 2 | Recruiting | NYU Langone Health | 60 | 2026-10-01 | 2026-10-15 |
| Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02) Iza-bren, Osimertinib, Pemetrexed - Non-Small Cell Lung Cancer | Phase 3 | Recruiting | Bristol-Myers Squibb | 850 | 2026-09-08 | 2026-10-26 |
| Osimertinib With or Without Primary Lung Tumor Resection for EGFR-Mutant Oligometastatic Non-Small Cell Lung Cancer Primary Tumor Resection, Osimertinib - Lung Neoplasms, Non-Small Cell Lung Cancer | Phase 3 | Recruiting | National Taiwan University Hospital | 154 | 2026-09-08 | 2026-09-09 |
| A Phase 2 Study of ABSK043 Combined With Osimertinib ABSK043 in combination with Osimertinib - Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive | Phase 2 | Not yet recruiting | Abbisko Therapeutics Co, Ltd | 72 | 2026-08-31 | 2026-07-17 |
| A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-small Cell Lung Cancer(Stage III) Whose Disease Has Not Progressed Following Definitive Platinum-based Chemoradiation Therapy(PANKU-Lung08) BL-B01D1, Osimertinib - Non-small Cell Lung Cancer Stage III | Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 418 | 2026-08-28 | 2026-09-10 |
| A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU-Lung09) BL-B01D1, Osimertinib, Carboplatin - Non-small Cell Lung Cancer | Phase 2 / Phase 3 | Recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | 90 | 2026-07-24 | 2026-08-03 |
| A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC) SKB571 for injection, Osimertinib, Furmonertinib - Non-Small Cell Lung Cancer | Phase 2 | Recruiting | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | 150 | 2026-07-15 | 2026-09-02 |
| A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer AK146D1 for injection, AK112 Injection, Platinum chemotherapy - Advanced Non Small Cell Lung Cancer (NSCLC) | Phase 2 | Recruiting | Akeso | 348 | 2026-07-10 | 2026-07-14 |
| Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of ALK202 for Injection in Combination With Drugs in NSCLC Participants. ALK202 for injection, Osimertinib Mesylate Tablets, Ivonescimab Injection - NSCLC (Advanced Non-small Cell Lung Cancer) | Phase 2 | Not yet recruiting | Shanghai Allink Biotherapeutics Co., Ltd. | 252 | 2026-06-30 | 2026-05-22 |
| Boosting Osimertinib Blood Brain Barrier Penetration Osimertinib & febuxostat - Non-Small Cell Lung Cancer | Phase 2 | Recruiting | Maastricht University Medical Center | 7 | 2026-06-01 | 2026-06-05 |
| A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCLC SYS6010, Osimertinib, platinum-pemetrexed - NSCLC | Phase 3 | Not yet recruiting | CSPC Megalith Biopharmaceutical Co.,Ltd. | 680 | 2026-06-01 | 2026-05-13 |
| A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer ANS014004 + PLB1004, ANS014004 + Osimertinib - Non-Small Cell Lung Cancer, EGFR Mutation | Phase 1 / Phase 2 | Not yet recruiting | Beijing Pearl Biotechnology Limited Liability Company | 253 | 2026-06-01 | 2025-12-16 |
| Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors IBI3005, Sintilimab, Bevacizumab biosimilar - Solid Tumor | Phase 1 / Phase 2 | Not yet recruiting | Innovent Biologics (Suzhou) Co. Ltd. | 282 | 2026-06-01 | 2026-05-28 |
| Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib Capivasertib in combination with Osimertinib - Lung Cancer (NSCLC), Lung Cancer (Non-Small Cell) | Phase 1 / Phase 2 | Not yet recruiting | Shanxi Province Cancer Hospital | 53 | 2026-05-15 | 2026-03-24 |
| Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients Osimertinib - EGFR-mutated NSCLC | Recruiting | Gruppo Oncologico Italiano di Ricerca Clinica | 100 | 2026-04-14 | 2026-04-22 | |
| A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer Ivonescimab, Dato-DXd, Osimertinib - Non-Small Cell Lung Cancer | Phase 1 / Phase 2 | Recruiting | Memorial Sloan Kettering Cancer Center | 66 | 2026-04-09 | 2026-07-13 |
| Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study Osimertinib - Lung Cancer | Phase 2 | Recruiting | AstraZeneca | 60 | 2026-04-01 | 2026-10-28 |
| Phase II Study 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 Sacituzumab Tirumotecan, Osimertinib - Non-Small Cell Lung Cancer | Phase 2 | Recruiting | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | 30 | 2026-03-30 | 2026-08-20 |
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Carcinoma, Non-Small-Cell Lung (186) · Lung Neoplasms (57) · Neoplasms (15) · Brain Neoplasms (11) · Neoplasm Metastasis (10) · Carcinoma (9) · Meningeal Carcinomatosis (6) · Bronchial Neoplasms (5) · Colorectal Neoplasms (5) · Thoracic Neoplasms (4) · Adenocarcinoma (3) · Adenocarcinoma of Lung (3) · Breast Neoplasms (3) · Carcinoma, Squamous Cell (3) · Lung Diseases (3)
AstraZeneca (44) · National Cancer Institute (NCI) (10) · Shanghai JMT-Bio Inc. (8) · Memorial Sloan Kettering Cancer Center (7) · Sichuan Baili Pharmaceutical Co., Ltd. (6) · AbbVie (5) · Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (5) · Guangdong Association of Clinical Trials (5) · Tianjin Medical University Cancer Institute and Hospital (5) · Fudan University (4) · M.D. Anderson Cancer Center (4) · Samsung Medical Center (4) · Dana-Farber Cancer Institute (3) · Jonsson Comprehensive Cancer Center (3) · Qingdao Central Hospital (3)
United States (110) · China (107) · South Korea (60) · Spain (43) · Taiwan (42) · Italy (33) · France (32) · Japan (29) · Canada (25) · United Kingdom (23) · Australia (22) · Germany (22) · Thailand (17) · Netherlands (16) · Singapore (16)
Helena Yu, MD (5) · Li Zhang (3) · Collin Blakely, MD, PhD (2) · Jonathan W Riess (2) · Li Zhang, M.D. (2) · Liu Anwen, Phd (2) · Nir Peled, MD PhD FCCP (2) · Sarah B Goldberg (2) · Serban Ghiorghiu, MSD (2) · Shun Lu, MD (2)
PMID 40311309, PMID 27959700, PMID 29151359, PMID 30512189, PMID 25175099, PMID 25923549, PMID 27435396, PMID 27751847, PMID 29293889, PMID 30059262, PMID 31085043, PMID 31345012, PMID 31751012, PMID 32027845, PMID 37379430, PMID 39029876, PMID 39732365, PMID 41166679, PMID 41534788, PMID 11099318, PMID 11937001, PMID 11948464, PMID 15258838, PMID 15844174, PMID 15897941, PMID 16805854, PMID 16983123, PMID 16990388, PMID 17150016, PMID 17374728, PMID 17894407, PMID 18172267, PMID 18245491, PMID 18612161, PMID 19624979, PMID 20156778, PMID 20595147, PMID 20627894, PMID 20818862, PMID 21215350, PMID 21488898, PMID 21499124, PMID 21670455, PMID 21784628, PMID 21844012, PMID 22271810, PMID 22487432, PMID 23552882, PMID 23937717, PMID 2406000
2023 (9), 2014 (8), 2015 (6), 2019 (4), U10CA180820 (4), 2017 (3), 2018 (3), 2016 (2), 2025 (2), P30CA033572 (2), UM1CA186689 (2), P30CA093373 (1), P30CA138292 (1), P50CA217691 (1), U10CA180868 (1)