Marrow Infiltrating Lymphocytes - Non-Small Cell Lung Cancer (MILs™ - NSCLC) Alone or in Combination With Nivolumab With or Without Tadalafil in Locally Advanced and Unresectable or Metastatic NSCLC
NCT04069936 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2022-08-02
Summary
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
Interventions
- BIOLOGICAL
-
MILs™ - NSCLC
To evaluate the safety of MILs™ - NSCLC alone in subjects with locally advanced and unresectable or metastatic NSCLC
- BIOLOGICAL
-
To evaluate the efficacy of MILs™ - NSCLC in combination with nivolumab in subjects with locally advanced and unresectable or metastatic NSCLC
- DRUG
-
tadalafil
To evaluate the efficacy of MILs™ - NSCLC in combination with nivolumab with or without tadalafil in subjects with locally advanced and unresectable or metastatic NSCLC
Sponsors & Collaborators
- collaborator INDUSTRY
-
WindMIL Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-15
- Primary Completion
- 2021-10-28
- Completion
- 2021-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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