Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597671
Status:
RECRUITING
Last Update Posted:
2023-06-05
First Post:
2020-09-24
Brief Title:
Durvalumab and Low-dose PCI vs Durvalumab and Observation in Radically Treated Patients With Stage III NSCLC NVALT28
Sponsor:
Association NVALT Studies
Organization:
Dutch Society of Physicians for Pulmonology and Tuberculosis
Study Overview
Official Title:
NVALT 28 PRL01 Durvalumab and Low-dose Prophylactic Cranial Irradiation PCI Versus Durvalumab and Observation in Radically Treated Patients With Stage III Non-small Cell Lung Cancer A Phase III Randomized Study
Status:
RECRUITING
Status Verified Date:
2023-06
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:
NVALT28
Brief Summary:
This trial studies the combination of low-dose PCI with or without durvalumab in patients with radically treated stage III NSCLC The hypothesis is that the incidence of brain metastases will be reduced from 30 to 15 with durvalumab and to a maximum of 5 with the addition of low-dose PCI This strategy would make brain metastases in stage III NSCLC history and this would improve QoL
Detailed Description:
The brain is frequently a site of disease relapse in Non-Small Cell Lung Cancer NSCLC patients For radically treated patients stage III has the highest risk for brain metastases with a cumulative incidence of brain metastases after radical treatment of approximately 30 for which there is no cure at the moment decreasing the long-term survival and Quality of Life Strategies to reduce incidence of brain metastases are necessary
Prophylactic Cranial Irradiation PCI has been shown to reduce the incidence of brain metastases in patients with NSCLC However PCI leads to a neurocognitive impairment in about 25 of patients without altering the QoL
The addition of durvalumab after chemo-radiotherapy in stage III NSCLC could reduce the incidence of brain metastases In pre-clinical models immunotherapy potentiates the effects of radiotherapy by a factor two to five This makes the combination of PCI and immunotherapy interesting to evaluate whether it can further decrease the percentage of brain metastases as well as preserve organ function as a lower radiation dose can probably be used when combined with an antiprogrammed death ligand1 PDL-1
The hypothesis of the NVALT28 trial is that the combination of PCI with durvalumab will decrease the incidence of brain metastases from 30 to 15 with durvalumab and to a maximum of 5 with the addition of low-dose PCI This strategy would make brain metastases in stage III NSCLC history and this would improve QoL
Prophylactic Cranial Irradiation PCI has been shown to reduce the incidence of brain metastases in patients with NSCLC However PCI leads to a neurocognitive impairment in about 25 of patients without altering the QoL
The addition of durvalumab after chemo-radiotherapy in stage III NSCLC could reduce the incidence of brain metastases In pre-clinical models immunotherapy potentiates the effects of radiotherapy by a factor two to five This makes the combination of PCI and immunotherapy interesting to evaluate whether it can further decrease the percentage of brain metastases as well as preserve organ function as a lower radiation dose can probably be used when combined with an antiprogrammed death ligand1 PDL-1
The hypothesis of the NVALT28 trial is that the combination of PCI with durvalumab will decrease the incidence of brain metastases from 30 to 15 with durvalumab and to a maximum of 5 with the addition of low-dose PCI This strategy would make brain metastases in stage III NSCLC history and this would improve QoL
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