Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
NCT ID:
NCT05500092
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.
Study:
NCT05500092
Study Brief:
Protocol Section:
NCT05500092