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A Phase 2a, Open-Label, Multi-Center Study to Assess the Efficacy and Safety of Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Subjects With Locally Advanced and Unresectable or Metastatic NSCLC Previously Treated With Anti-PD-1

ClinicalTrials.gov · TERMINATED, 2021

19 participants

Abstract

The purpose of this study is to determine the safety and efficacy of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil in subjects with locally advanced and unresectable or metastatic NSCLC who are refractory or relapsing to a PD-1 containing regimen.

Conditions: Non Small Cell Lung Cancer, Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Non-small Cell, Non Small Cell Lung Cancer Metastatic, NSCLC, Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Metastatic.

Primary outcome: Adverse Events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0; Serious Adverse Events per NCI-CTCAE version 5.0; Overall Response Rate (ORR) of MILs™ - NSCLC in combination with nivolumab with or without tadalafil.

Enrollment: 19 participants.

How strong is the evidence?

Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 19 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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