Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-26 @ 11:23 AM
Study NCT ID:
NCT05500092
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2022-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer
Sponsor:
Montefiore Medical Center
Organization:
Study Overview
Official Title:
An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-02
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:
CA209-6K6
Brief Summary:
An open label, randomized study of neoadjuvant nivolumab and chemotherapy, with or without sub-ablative stereotactic body radiation therapy, for resectable stage IIA to IIIB non-small cell lung cancer
Detailed Description:
Primary Objective
* To compare the complete pathological response rate after 3 cycles of neoadjuvant nivolumab and platinum-based doublet chemotherapy vs. the same regimen with the addition of sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor.
Secondary Objectives
* To characterize the rate of Major Pathological Response (MPR), defined as ≤ 10% residual viable tumor cells at the time of surgical resection in the primary tumor and lymph nodes, as assessed by local pathology laboratory.
* To characterize rates of Event Free Survival (EFS), defined as survival without documented disease progression per RECIST v1.1 that precludes surgery for local or distant disease recurrence.
Exploratory Objectives
* To characterize the rate of pathological downstaging of biopsy confirmed positive lymph nodes not in the stereotactic body radiation therapy (SBRT) field.
* To characterize rates of Disease-Free Survival (DFS), defined as survival without local or distant recurrence or occurrence of new primary NSCLC.
* To characterize rates of Overall Survival (OS) after study enrollment.
* To characterize the incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
* To describe surgical safety and the incidence and severity of surgery-related adverse events.
* To characterize rates of clearance of ctDNA (circulating tumor DNA) following neoadjuvant therapy and definitive surgical treatment
* To evaluate whole tumor RNAseq (RNA-sequencing) from pre- and post- treatment tissue samples to assess for predictors and signatures of pathologic response.
* To evaluate of gene expression in pre- and post-treatment blood samples to assess for predictors and signatures of complete pathologic response.
* To assess the expression characteristics of PD-L1, infiltrating immune cells and TMB (tumor mutational burden), and their association with clinical outcomes.
* To compare the complete pathological response rate after 3 cycles of neoadjuvant nivolumab and platinum-based doublet chemotherapy vs. the same regimen with the addition of sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor.
Secondary Objectives
* To characterize the rate of Major Pathological Response (MPR), defined as ≤ 10% residual viable tumor cells at the time of surgical resection in the primary tumor and lymph nodes, as assessed by local pathology laboratory.
* To characterize rates of Event Free Survival (EFS), defined as survival without documented disease progression per RECIST v1.1 that precludes surgery for local or distant disease recurrence.
Exploratory Objectives
* To characterize the rate of pathological downstaging of biopsy confirmed positive lymph nodes not in the stereotactic body radiation therapy (SBRT) field.
* To characterize rates of Disease-Free Survival (DFS), defined as survival without local or distant recurrence or occurrence of new primary NSCLC.
* To characterize rates of Overall Survival (OS) after study enrollment.
* To characterize the incidence of adverse events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
* To describe surgical safety and the incidence and severity of surgery-related adverse events.
* To characterize rates of clearance of ctDNA (circulating tumor DNA) following neoadjuvant therapy and definitive surgical treatment
* To evaluate whole tumor RNAseq (RNA-sequencing) from pre- and post- treatment tissue samples to assess for predictors and signatures of pathologic response.
* To evaluate of gene expression in pre- and post-treatment blood samples to assess for predictors and signatures of complete pathologic response.
* To assess the expression characteristics of PD-L1, infiltrating immune cells and TMB (tumor mutational burden), and their association with clinical outcomes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: