CLINICAL TRIALS PROFILE FOR OSIMERTINIB MESYLATE
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All Clinical Trials for Osimertinib Mesylate
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT04798638 ↗ | A Study to Assess the Effect of Food on the Pharmacokinetics of TY-9591 in Healthy Volunteers | Recruiting | TYK Medicines, Inc | Phase 1 | 2021-05-01 | To assess the pharmacokinetics of TY-9591 tablets and Osimertinib Mesylate tablets after a single fasting administration and the effect of food on the pharmacokinetics of TY-9591 tablets in healthy volunteers. |
| NCT05020457 ↗ | A Phase II/III Study of SI-B001 in Combination With Osimertinib in the Treatment of EGFR/ALK WT Recurrent and Metastatic NSCLC | Not yet recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | Phase 2/Phase 3 | 2021-10-01 | Main purpose: 1. To explore the efficacy of SI-B001 at RP2D obtained in phase I clinical trial and single low dose combined with chemotherapy in patients with locally advanced or metastatic NSCLC. 2. To explore the safety and tolerability of SI-B001 in patients with locally advanced or metastatic lung cancer (NSCLC) at RP2D obtained in phase I clinical trial and single-dose low-dose combination chemotherapy, and to select the optimal dose (combined with RP2D) and mode of SI-B001 combined with chemotherapy. |
| NCT05020769 ↗ | A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in Combination With Osimertinib Mesylate Tablets in the Treatment of Recurrent and Metastatic Non- Small Cell Lung Cancer | Not yet recruiting | Sichuan Baili Pharmaceutical Co., Ltd. | Phase 2/Phase 3 | 2021-10-01 | Main purpose: 1. To explore the efficacy of SI-B001 at RP2D obtained in phase I clinical trial and single low dose combined with Osimertinib in patients with locally advanced or metastatic NSCLC. 2. To explore the safety and tolerability of SI-B001 in patients with locally advanced or metastatic lung cancer (NSCLC) at RP2D obtained in phase I clinical trial and single-dose low-dose combination chemotherapy, and to select the optimal dose (combined with RP2D) and mode of SI-B001 combined with Osimertinib. |
| NCT05085054 ↗ | Salvage Surgery Following Downstaging of Advanced Non-small Cell Lung Cancer by Targeted Therapy (SDANT) | Not yet recruiting | Wuhan Union Hospital, China | Phase 2 | 2021-11-01 | The purpose of this study is to evaluate the safety and efficacy of neoadjuvant targeted therapy followed by surgery in participants with advanced non-small cell lung cancer. |
| NCT05284994 ↗ | TQ-B3525 Tablets Combined With Osimertinib Mesylate Tablets in the Treatment of Advanced Non-Small Cell Lung Cancer | Recruiting | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Phase 1/Phase 2 | 2022-03-11 | TQ-B3525 tablet is a new α/δ dual inhibitor phosphatidylinositol 3-kinase inhibitor developed by Chia Tai Tianqing pharmaceutical Group Co., Ltd. It can overcome the drug resistance problem caused by the up-regulation of phosphatidylinositol 3-kinase α subunit activity caused by the single inhibition of phosphatidylinositol 3-kinase δ subunit. This study is a single-arm, open-label, multi-cohort, multi-center clinical study of the safety and efficacy of TQ-B3525 tablets combined with osimertinib in subjects with advanced non-small cell lung cancer, aiming to evaluate TQ-B3525 tablets combined with osimertinib, the safety, tolerability, and efficacy of the treatment of patients with advanced non-small cell lung cancer who have failed epidermal growth factor receptor inhibitor therapy, while exploring the efficacy, resistance mechanism, and safety in the dose escalation phase biomarkers. |
| NCT05816252 ↗ | A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) | Not yet recruiting | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | Phase 2 | 2023-04-12 | The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer. |
| NCT05816252 ↗ | A Study of SKB264 for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) | Not yet recruiting | Klus Pharma Inc. | Phase 2 | 2023-04-12 | The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for Osimertinib Mesylate
Condition Name
Clinical Trial Locations for Osimertinib Mesylate
Clinical Trial Progress for Osimertinib Mesylate
Clinical Trial Phase
Clinical Trial Sponsors for Osimertinib Mesylate
Sponsor Name
| Sponsor Name for Osimertinib Mesylate | |
| Sponsor | Trials |
| Sichuan Baili Pharmaceutical Co., Ltd. | 3 |
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | 1 |
| Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. | 1 |
| [disabled in preview] | 3 |
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