Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622174
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer PROMISE - Phase I Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
PROMISE
Brief Summary:
This phase I study aims to evaluate the safety and effectiveness of adaptive pulsed radiotherapy combined with immunotherapy in patients with metastatic non-small cell lung cancer NSCLC resistant to immune checkpoint inhibitors The primary goal is to assess treatment-related toxicity while secondary objectives include progression-free survival overall survival and quality of life The study will enroll 32 patients
Detailed Description:
Background Non-small cell lung cancer NSCLC accounts for approximately 85 of all lung cancer cases and is a leading cause of cancer-related death globally Despite the success of immune checkpoint inhibitors ICIs targeting PD-1 and PD-L1 many patients develop resistance to these therapies either at the start primary resistance or over time secondary resistance This resistance leads to disease progression during or after treatment posing a major clinical challenge Recent studies suggest that combining ICIs with radiotherapy may improve treatment outcomes Advances in pulsed radiotherapy including stereotactic radiation cycles have shown promising results in overcoming ICI resistance in metastatic disease
Objective This phase I prospective study aims to evaluate the safety primary objective and efficacy of pulsed radiotherapy in combination with PDL-1 inhibitors with or without chemotherapy in patients with polymetastatic NSCLC who have developed systemic resistance The hypothesis is that this combination approach could improve patient outcomes by directly reducing tumor burden and enhancing the immune response while maintaining an acceptable toxicity profile
Methods This single-arm phase I study will enroll 32 patients with NSCLC who show disease progression in 5 extracranial sites while on PDL-1 inhibitors with or without chemotherapy Pulsed radiotherapy will be delivered in up to 3 cycles targeting 2 to 5 progressive lesions per cycle Eligible participants must be 18 years or older with systemic progression of NSCLC in 5 sites during treatment with ICIs and an ECOG performance status of 0-2 Brain metastases are permitted but will not be included in the lesion count
The primary endpoint is dose-limiting toxicity DLT defined by the Common Terminology Criteria for Adverse Events CTCAE version 50 focusing on grade 3-5 adverse events related to radiotherapy within 180 days of treatment Secondary endpoints include the development of a clinical workflow for adaptive pulsed radiotherapy progression-free survival PFS overall survival OS local recurrence time to the next systemic treatment and patient-reported quality of life
Objective This phase I prospective study aims to evaluate the safety primary objective and efficacy of pulsed radiotherapy in combination with PDL-1 inhibitors with or without chemotherapy in patients with polymetastatic NSCLC who have developed systemic resistance The hypothesis is that this combination approach could improve patient outcomes by directly reducing tumor burden and enhancing the immune response while maintaining an acceptable toxicity profile
Methods This single-arm phase I study will enroll 32 patients with NSCLC who show disease progression in 5 extracranial sites while on PDL-1 inhibitors with or without chemotherapy Pulsed radiotherapy will be delivered in up to 3 cycles targeting 2 to 5 progressive lesions per cycle Eligible participants must be 18 years or older with systemic progression of NSCLC in 5 sites during treatment with ICIs and an ECOG performance status of 0-2 Brain metastases are permitted but will not be included in the lesion count
The primary endpoint is dose-limiting toxicity DLT defined by the Common Terminology Criteria for Adverse Events CTCAE version 50 focusing on grade 3-5 adverse events related to radiotherapy within 180 days of treatment Secondary endpoints include the development of a clinical workflow for adaptive pulsed radiotherapy progression-free survival PFS overall survival OS local recurrence time to the next systemic treatment and patient-reported quality of life
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