ALK-positive NSCLC Clinical Trial
Official title:
A Phase II, Multi-center, Open-label, Single-Arm Study to Evaluate the Efficacy and Safety of Oral XZP-3621 Treatment for Chinese Patients With ALK-Positive Non-Small Cell Lung Cancer
This was a single-arm, open-label, multicenter, phase II study to evaluate the efficacy and safety of the ALK inhibitor XZP-3621 when used as single agent in patients with ALK-rearranged stage IIIB, IIIC or IV NSCLC previously treated with other ALK inhibitors or non-previously treated.
This is a Phase 2, China only, multi center, open label, three cohorts study, in ALK positive locally advanced or metastatic NSCLC patients will be enrolled to receive XZP-3621 monotherapy. (in Cohort 1) Treatment-Naive with any ALK inhibitor. (in Cohort 2) Disease progression after crizotinib as the only ALK inhibitor. (in Cohort 3) Disease progression after other ALK inhibitors,including or not including crizotinib previously treated. The patients will receive XZP-3621 at 500 mg orally once daily (QD), taken with food.Patients will be treated until disease progression, unacceptable toxicity, withdrawal of consent, or death, whichever occurred first. After disease progression (as per RECIST v1.1), patients should discontinue the study medication. After disease progression, patients will be treated at the discretion of the investigator according to local practice. Information regarding the nature and the duration of subsequent therapies will be collected. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02393625 -
Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT03804541 -
The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human
|
Phase 1 | |
| Completed |
NCT04647110 -
Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers.
|
||
| Recruiting |
NCT04056572 -
Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
|
Phase 2 | |
| Recruiting |
NCT04009317 -
Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)
|
Phase 3 |