Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501378
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-09
Brief Title:
Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Active Brain Metastasis
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Cranial Radiotherapy Plus PD-1PD-L1 Inhibitors and Chemotherapy in Untreated Driver-mutation Negative Non-small Cell Lung Cancer With Active Brain Metastasis BRILLIANT-1
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Non-small cell lung cancer NSCLC the most prevalent form of lung cancer has a significant risk of brain metastasis BM Historically the median overall survival for advanced NSCLC patients with BM was under six months with traditional chemotherapy However recent advancements with immune checkpoint inhibitors ICIs have shown promise with some studies reporting improved intracranial objective response rates progression-free survival and overall survival when combined with chemotherapy
Despite these improvements challenges remain such as treatment resistance recurrence and the need for better therapeutic strategies Local interventions like stereotactic radiotherapy SRT and whole brain radiation therapy WBRT have been crucial for treating BM with SRT being particularly effective The combination of immunotherapy and radiotherapy is emerging as a synergistic approach with studies suggesting it may enhance local control and survival rates while maintaining safety
Guidelines recommend SRT for patients with limited BMs and clinical data support the safety and efficacy of combining brain radiotherapy with immunotherapy A meta-analysis and other studies have shown promising results with this combination including local control rates and overall survival benefits with manageable toxicities
However there is still a need for more prospective clinical trials to verify the safety and efficacy of combining cranial radiotherapy with immunotherapy in NSCLC patients with BM especially those without driver gene mutations Therefore we plan to conduct a phase 2 prospective study focusing on combining brain radiotherapy with PD-1PD-L1 inhibitors Though most of the current studies excluded patients with active BM we believe that these patients need more attention In this trial we focus on patients with active BM and treat them with PD-1PD-L1 inhibitor chemotherapy and SRTWBRT
Despite these improvements challenges remain such as treatment resistance recurrence and the need for better therapeutic strategies Local interventions like stereotactic radiotherapy SRT and whole brain radiation therapy WBRT have been crucial for treating BM with SRT being particularly effective The combination of immunotherapy and radiotherapy is emerging as a synergistic approach with studies suggesting it may enhance local control and survival rates while maintaining safety
Guidelines recommend SRT for patients with limited BMs and clinical data support the safety and efficacy of combining brain radiotherapy with immunotherapy A meta-analysis and other studies have shown promising results with this combination including local control rates and overall survival benefits with manageable toxicities
However there is still a need for more prospective clinical trials to verify the safety and efficacy of combining cranial radiotherapy with immunotherapy in NSCLC patients with BM especially those without driver gene mutations Therefore we plan to conduct a phase 2 prospective study focusing on combining brain radiotherapy with PD-1PD-L1 inhibitors Though most of the current studies excluded patients with active BM we believe that these patients need more attention In this trial we focus on patients with active BM and treat them with PD-1PD-L1 inhibitor chemotherapy and SRTWBRT
Detailed Description:
None
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