NCT04069936 is a Phase 2 clinical trial of MILs™ - NSCLC in Non Small Cell Lung Cancer, sponsored by WindMIL Therapeutics.

Who is sponsoring NCT04069936?

NCT04069936 is sponsored by WindMIL Therapeutics.

What drugs are being tested in NCT04069936?

Interventions in NCT04069936: MILs™ - NSCLC, nivolumab, tadalafil.

What condition does NCT04069936 study?

NCT04069936 studies 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.

Is NCT04069936 still recruiting?

NCT04069936 is currently terminated. Last updated 2 August 2022.

Last reviewed 2022-08-02 · How we verify

NCT04069936

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Last updated 2 August 2022

What this trial tests

Phase 2 trial testing MILs™ - NSCLC in Non Small Cell Lung Cancer in 19 participants. Terminated before completion.

Timeline

15 October 2019

Primary endpoint
28 October 2021

30 November 2021

Quick facts

Lead sponsor	WindMIL Therapeutics
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	15 October 2019
Primary completion	28 October 2021
Estimated completion	30 November 2021
Sites	10 locations across United States

Drugs / interventions tested

MILs™ - NSCLC — full drug profile →
nivolumab (nivolumab) — full drug profile →
tadalafil (tadalafil) — full drug profile →

Conditions studied

Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
Lung Cancer — all drugs for Lung Cancer →
Lung Cancer Metastatic — all drugs for Lung Cancer Metastatic →
Lung Cancer, Non-small Cell — all drugs for Lung Cancer, Non-small Cell →

Sponsor

WindMIL Therapeutics — full company profile →

Who can join

18 and older, any sex, with Non Small Cell Lung Cancer or Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
cAMP-PKA/EPAC signaling and cancer: the interplay in tumor microenvironment.
Zhang H, Liu Y, Liu J, Chen J, et al · · 2024 · cited 90× · PMID 38233872 · DOI 10.1186/s13045-024-01524-x
Pros and Cons of Pharmacological Manipulation of cGMP-PDEs in the Prevention and Treatment of Breast Cancer.
Di Iorio P, Ronci M, Giuliani P, Caciagli F, et al · · 2021 · cited 13× · PMID 35008687 · DOI 10.3390/ijms23010262
The Multifaceted Role of Neutrophils in NSCLC in the Era of Immune Checkpoint Inhibitors.
Miao S, Rodriguez BL, Gibbons DL. · · 2024 · cited 3× · PMID 39061147 · DOI 10.3390/cancers16142507

Verify or expand the search:

Other recruiting trials for Non Small Cell Lung Cancer

Currently open trials in the same condition.

NCT06951646 — ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immuno · Phase 2 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting
NCT07306624 — Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer · Phase 2 · recruiting
NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04069936 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by WindMIL Therapeutics
Last refreshed: 2 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04069936.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing