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Last Updated: November 22, 2024

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 >Phase >Start Date >Summary

Clinical Trial Conditions for OSIMERTINIB MESYLATE

Condition Name

Condition Name for OSIMERTINIB MESYLATE
Intervention Trials
Non-small Cell Lung Cancer 3
Non Small Cell Lung Cancer 2
Nonsmall-cell Lung Cancer 1
Healthy Volunteers 1
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Condition MeSH

Condition MeSH for OSIMERTINIB MESYLATE
Intervention Trials
Carcinoma, Non-Small-Cell Lung 6
Lung Neoplasms 6
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Clinical Trial Locations for OSIMERTINIB MESYLATE

Trials by Country

Trials by Country for OSIMERTINIB MESYLATE
Location Trials
China 6
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Clinical Trial Progress for OSIMERTINIB MESYLATE

Clinical Trial Phase

Clinical Trial Phase for OSIMERTINIB MESYLATE
Clinical Trial Phase Trials
Phase 2/Phase 3 2
Phase 2 3
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for OSIMERTINIB MESYLATE
Clinical Trial Phase Trials
Not yet recruiting 5
Recruiting 2
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Clinical Trial Sponsors for OSIMERTINIB MESYLATE

Sponsor Name

Sponsor Name for OSIMERTINIB MESYLATE
Sponsor Trials
Sichuan Baili Pharmaceutical Co., Ltd. 3
TYK Medicines, Inc 1
Wuhan Union Hospital, China 1
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Sponsor Type

Sponsor Type for OSIMERTINIB MESYLATE
Sponsor Trials
Industry 7
Other 1
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