Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363734
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-09
Brief Title:
Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant CDK46 Pathway Aberrant Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI a Phase II Trial
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Organization:
Tianjin Medical University Cancer Institute and Hospital
Study Overview
Official Title:
Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant CDK46 Pathway Aberrant Advanced Non-small Cell Lung Cancer Following Acquired Resistance on Third-generation EGFR TKI a Single-arm Phase II Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective single-arm phase II trial It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant CDK46 pathway aberrant advanced NSCLC following acquired resistance to third-generation EGFR TKI
Detailed Description:
After signing informed consents and completing the screening phase eligible subjects who meet the enrolment criteria receive the treatment with once-daily osimertinib 80 mg plus dalpiciclib 125 mg daily for 21 consecutive days followed by 7 days off in each 28-day cycle until objective disease progression intolerable toxicity or other events that subjects need to be withdrawn from the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None