Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT07285434
Description:
The following de-identified, participant-level data will be included:
Core clinical efficacy data Demographics and baseline disease characteristics (e.g. age, sex, ECOG performance status, histology, PD-L1 tumor proportion score strata, presence/absence of actionable oncogenic drivers).
Treatment assignment (study arm) and treatment exposure (dates and number of cycles of Microlyvaq™, pembrolizumab, platinum/taxane or pemetrexed-based chemotherapy).
Tumor response assessments per RECIST v1.1 (target lesion measurements, best overall response, confirmation status).
Time-to-event endpoints: progression-free survival (PFS), duration of response (DoR), overall survival (OS), and censoring information (dates and reasons).
Disease control status at protocol-defined timepoints. Concomitant anti-cancer therapies received after on-study treatment discontinuation.
Study:
NCT07285434
Study Brief:
Clinical Study of the Therapeutic Effectiveness of In-silico-Designed, Machine Learning Inspired, and Quantum-molecularly Coupled Personalized Neoantigenic Vaccines Microlyvaq™ in Patients With Advanced Non-small Cell Lung Cancer