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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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