Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570317
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Multicentre Phase II Clinical Study of Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is aimed at patients with unresectable NSCLC who take nintedanib during sequential radiotherapy to explore the incidence of radiation pneumonitis above grade 2 in the nintedanib combined with radiotherapy mode and observe safety And will further explore the progression-free survival PFS and overall survival OS of patients treated with nintedanib in combination with radiotherapy and immunotherapy
Primary objective To evaluate the safety of nintedanib combined with sequential radiotherapy in patients with unresectable NSCLC and the incidence of radiation pneumonitis above grade 2 Secondary objective To evaluate the changes in lung function progression-free survival PFS and overall survival OS in patients with unresectable NSCLC after nintedanib combined with sequential radiotherapy
Patients need to receive induction therapy chemotherapy andor immunotherapy for at least one cycle Then they will receive sequential radiotherapy and nintedanib for 6 months Finally they will receive immunotherapy maintenance therapy for 16 cycles
Primary objective To evaluate the safety of nintedanib combined with sequential radiotherapy in patients with unresectable NSCLC and the incidence of radiation pneumonitis above grade 2 Secondary objective To evaluate the changes in lung function progression-free survival PFS and overall survival OS in patients with unresectable NSCLC after nintedanib combined with sequential radiotherapy
Patients need to receive induction therapy chemotherapy andor immunotherapy for at least one cycle Then they will receive sequential radiotherapy and nintedanib for 6 months Finally they will receive immunotherapy maintenance therapy for 16 cycles
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None