Clinical Trials Logo
  1. Home
  2. Non-Small-Cell Lung Carcinoma
  3. NCT05869162

Phase II Study of SY-3505 in Patients With ALK-positive NSCLC Who Have Failed Prior Second-Generation ALK TKI

Non-small-cell Lung Carcinoma Clinical Trial

Official title:
A Phase II, Open-Label, Single-Arm, Multicenter Study of Efficacy and Safety of SY-3505 in Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer Who Have Progressed On or Are Intolerant to Second-Generation ALK TKI

Clinical Trial Summary

This is an open-label, single-arm, multicenter, phase II study to evaluate the efficacy and safety of SY-3505 capsule in patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to second-generation ALK tyrosine kinase inhibitor (TKI).

Clinical Trial Description

SY-3505 is a potent, brain-penetrant, third-generation ALK tyrosine kinase inhibitor (TKI) with preclinical activity against both wild-type and most known resistance mutations of ALK occurring in first-generation and second-generation ALK TKI-resistant patients. In this phase 2 study, patients with locally advanced or metastatic NSCLC who have progressed on or are intolerant to second-generation ALK TKI will be treated with SY-3505 capsules at 600 mg once daily (QD) orally until disease progression, refusal or unacceptable toxicity. Cycles of treatment are every 21 days with continuous dosing of SY-3505. During the study, patients will be followed-up for safety and efficacy evaluation at study protocol defined time points. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05869162
Study type Interventional
Source Shouyao Holdings (Beijing) Co. LTD
Contact Yinghui Sun
Phone 86-10-88858616
Email yhsun@centaurusbio.com
Status Recruiting
Phase Phase 2
Start date June 30, 2023
Completion date June 10, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT00985855 - Feasibility of Cetuximab Associated With Concomitant Radio-Chemotherapy in Patients With Locally Advanced Non Small Cell Lung Cancer Phase 2
Completed NCT01048645 - Effect of All-trans Retinoic Acid With Chemotherapy Based in Paclitaxel and Cisplatin as First Line Treatment of Patients With Advanced Non-small Cell Lung Cancer Phase 2
Completed NCT00129844 - Study of Motexafin Gadolinium (MGd) for Second Line Treatment of Non-Small-Cell Lung Cancer Phase 2
Completed NCT00098085 - Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer Phase 2
Active, not recruiting NCT04995523 - A Study of AZD2936 Anti-TIGIT/Anti-PD-1 Bispecific Antibody in Participants With Advanced or Metastatic NSCLC Phase 1/Phase 2
Completed NCT00910676 - Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors Phase 2
Withdrawn NCT00108186 - Celecoxib Treatment for Lung Cancer Phase 1
Recruiting NCT05037825 - The Gut Microbiome and Immune Checkpoint Inhibitor Therapy in Solid Tumors
Recruiting NCT00379717 - Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Completed NCT00404924 - ZD6474 (ZACTIMA™) Phase III Study in EGFR Failures Phase 3
Completed NCT00102505 - A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC) Phase 1
Recruiting NCT02905591 - A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC Phase 2
Active, not recruiting NCT03088540 - Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Phase 3
Terminated NCT00271323 - Safety Study of Docetaxel/Cisplatin Induction Therapy Followed by Concurrent Chemoradiotherapy or Concurrent Chemoradiotherapy Followed by Consolidation Docetaxel/Cisplatin in NSCLC Patients Phase 2
Terminated NCT00232206 - Trial of Neoadjuvant Docetaxel and Cisplatin for Resectable Non-Small Cell Lung Cancer Phase 2
Completed NCT00037817 - Phase I Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion With or Without Concurrent Celecoxib in Subjects With Pulmonary and Pleural Malignancies Phase 1
Completed NCT03444766 - Study of Nivolumab for Advanced Cancers in India Phase 4
Completed NCT04351334 - Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC) Post-alectinib Treatment Patterns
Active, not recruiting NCT02416739 - Anticancer Activity of Nicotinamide on Lung Cancer Phase 2/Phase 3
Completed NCT00444015 - Phase I Dasatinib/Erlotinib in Recurrent Non-small Cell Lung Cancer (NSCLC) Phase 1