EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis
Categories (click each to see list of all clinical trials associated with that category): Thoracic (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Ganti, Apar
Eligibility: https://clinicaltrials.gov/study/NCT03793179?term=NCT03793179&rank=1
Summary
Primary:
1. Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 5 years post
treatment ] OS distributions will be estimated using the Kaplan-Meier method.
Secondary:
1. Progression-free survival (PFS) [ Time Frame: From randomization to documented disease progression or death
from any cause, assessed up to 5 years post treatment ] PFS distributions will be estimated using the Kaplan-Meier method.
2. Best objective response [ Time Frame: Up to 5 years post treatment ] Best objective response will be evaluated via Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
3. Incidence of adverse events [ Time Frame: Up to 30 days post treatment ]
Toxicities will be reported via the Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0. Toxicity rates between arms in the overall population will be compared using Fisher's exact tests with a one-sided type I error rate of 1.25%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes.
4. PD-L1 positivity [ Time Frame: At baseline ]
PD-L1 positivity will be defined as >= 1% Tumor Proportion Score (TPS) for the purpose of enrollment onto the trial. Strongly PD-L1 positive is defined as >= 50% TPS; weakly positive is defined as 1% - 49% TPS