Non Small Cell Lung CancerPhase 2NCT04069936
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
A Phase 2 study testing MILs™ - NSCLC, nivolumab and tadalafil in people with Non Small Cell Lung Cancer and Lung Cancer, run by WindMIL Therapeutics at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Lung Cancer, Lung Cancer Metastatic
- What is being tested?
- MILs™ - NSCLC, nivolumab and tadalafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 10 sitesUnited States
- Study dates
- 15 Oct 2019to 30 Nov 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Locally advanced and unresectable, or metastatic NSCLC.
- Histologically or cytologically confirmed, either squamous or non-squamous NSCLC.
- Measurable disease as per RECIST 1.1
- Willingness to undergo bone marrow aspiration (BMA).
- No more than one treatment regimen following an anti-PD-1 antibody containing treatment regimen prior to BMA collection.
Show all 14Show fewer
- Subjects may have BMA collected while on an anti-PD-1 antibody containing treatment regimen or while on a treatment regimen immediately following an anti-PD-1 antibody containing treatment regimen.
- BMA may be collected while on an anti-PD-1 antibody containing treatment regimen or while on a treatment regimen immediately following an anti-PD-1 antibody containing treatment regimen. However, the subjects must have radiographic evidence of disease progression prior to lymphodepletion.
- ≥ 21 days have lapsed since last cytotoxic chemotherapy treatment prior to collection of the BMA.
- Previous treatment with the appropriate targeted therapy if the subject has known EGFR/ALK/ROS1 rearrangements.
- Willingness to provide a fresh tumor biopsy during Screening Period or formalin-fixed, paraffin-embedded tissue collected at the time of most recent relapse. Note: Archival tissue regardless of biopsy date may be considered.
- Adequate renal, hepatic and bone marrow function defined as total bilirubin </= 1.5 x ULN (except for subjects with Gilbert's disease ≤ 3.0 x ULN with direct bilirubin </= 1.5 x ULN ). Aminotransferase (AST) / Alanine Aminotransferase (ALT) </= 3.0 X ULN (subjects with liver involvement will be allowed </= 5.0 X ULN). Serum creatinine </= 1.5 x ULN; if serum creatinine is 1.5 to 2.0 × ULN, then the creatinine clearance (calculated using the Cockcroft-Gault formula or measured) must be ≥ 40 mL/min. Lymphocyte >/= 0.7 x 10^9/L. ANC >/= 1.5 x 10^9/L. Platelets >/= 100 × 10^9/L. WBC >/= 2.0 ×10^9/L. Hemoglobin > 9.0 g/dL.
- Women of childbearing potential and male subjects (even if they are surgically sterilized or had a vasectomy) and their partners must agree to abstain or to use an effective form of birth control during the study for at least 6 months following administration of the last dose of lymphodepletion or for at least 5 months following the last dose of nivolumab for females and 7 months for males, whichever is longer. In addition, male subjects must not donate sperm during this period.
- Capable of giving and has provided a signed ICF, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Insufficient activation/expansion of T cells or other problems with the subject's MILs™ - NSCLC product which would prohibit administration.
- Major surgical procedure within 7 days of the first dose of lymphodepletion treatment.
- Prior malignancy active within the previous 3 years from date of BMA collection except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- Subjects with symptomatic uncontrolled brain metastases requiring treatment with steroids or anti-seizure medications within 28 days prior to the BMA are excluded. However, participants with brain metastases that have been previously treated and are stable on subsequent scan(s) are allowed and subjects with untreated possible brain metastases that are new at the time of screening and are < 1 cm and asymptomatic are allowed. Subjects with asymptomatic untreated CNS disease may undergo BMA prior to treatment of such disease.
- Infection requiring treatment with intravenous antibiotics, antifungal, or antiviral agents within 7 days prior to the BMA.
- Presence of an autoimmune disease requiring active systemic treatment.
Show all 18Show fewer
- Clinically significant, uncontrolled cardiovascular disease, including congestive heart failure Grade III or IV according to the New York Heart Association classification, myocardial infarction or unstable angina within the previous 6 months prior to BMA collection.
- Known diagnosis of human immunodeficiency virus (HIV) or active viral hepatitis.
- Administration of neutrophil growth factor support within 14 days prior to the BMA.
- Use of systemic corticosteroids (glucocorticoids) for greater than one day within 28 days prior to the BMA.
- Planned use of systemic corticosteroids (glucocorticoids) for greater than one day within 28 days prior to MILs™ - NSCLC administration.
- Prior radiation to both sides of the pelvis. Prior radiation to one side of the pelvis is permitted as long as the other side of the pelvis.
- Subjects with history of life-threatening toxicity related to prior immune therapy except those that are unlikely to re-occur with standard countermeasures.
- Receipt of live attenuated vaccine within 30 days of planned Day 0.
- History of allergy or hypersensitivity to MILs™-NSCLC, cyclophosphamide, fludarabine, nivolumab, tadalafil or their components.
- Pregnant or lactating females.
- Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the subject or impair the assessment of study results.
- Unwilling or unable to comply with the protocol.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University
Atlanta, Georgia, 30322
Cleveland Clinic
Cleveland, Ohio, 44195
Karmanos Cancer Center
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
University of California - Los Angeles
Los Angeles, California, 90095
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Washington University
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: 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
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.
Read the detailed description
This study will examine the safety and efficacy of Marrow Infiltrating Lymphocytes-Non-Small Cell Lung Cancer (MILs™ - NSCLC) combined with nivolumab with or without tadalafil in subjects with locally advanced and unresectable and metastatic NSCLC who were refractory to, or have relapsed on, an anti-PD-1 containing regimen. MILs™ - NSCLC are an adoptive cell therapy product derived via the activation and expansion of bone marrow T cells. Subjects will have bone marrow harvested during the Screening Period which will be used to manufacture the MILs™ - NSCLC. The MILs™ - NSCLC will then be administered on Day 0. Nivolumab will be administered on Day 1 and will continue every four weeks until treatment discontinuation. Tadalafil will be administered on Day 1 and will continue daily until treatment discontinuation.
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Non-small Cell, Non Small Cell Lung Cancer Metastatic, NSCLC
- Being tested
- MILs™ - NSCLC, nivolumab, tadalafil
- Keywords
- metastatic, locally advanced, lung cancer, non-small cell lung cancer, unresectable, NSCLC, cell therapy, autologous cell therapy, adoptive cell therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MILs™ - NSCLCBiological
Also called Marrow Infiltrating Lymphocytes
To evaluate the safety of MILs™ - NSCLC alone in subjects with locally advanced and unresectable or metastatic NSCLC
nivolumabBiological
To evaluate the efficacy of MILs™ - NSCLC in combination with nivolumab in subjects with locally advanced and unresectable or metastatic NSCLC
tadalafilDrug
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
| Study group | Role | What they receive |
|---|---|---|
| MILs™ - NSCLC plus nivolumab with or without tadalafil | Experimental | Locally advanced and unresectable and metastatic NSCLC subjects previously treated with anti-programmed cell death-1 (PD-1) will be treated with MILs™ - NSCLC plus nivolumab with or without tadalafil. Receives: Biological: MILs™ - NSCLC; Biological: nivolumab; Drug: tadalafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0
Incidence, intensity, and type of AE
Measured: From ICF through 100 days after the last dose of study treatment
Serious Adverse Events per NCI-CTCAE version 5.0
Incidence, intensity, and type of SAE
Measured: From ICF through 100 days after the last dose of study treatment
Overall Response Rate (ORR) of MILs™ - NSCLC in combination with nivolumab with or without tadalafil
Proportion of subjects with reduction in tumor burden of a predefined amount per RECIST 1.1
Measured: 24 months
Secondary outcomes (16)
Duration of response
Duration from first documented evidence of CR or PR until the first documented evidence of PD or death due to any cause, whichever occurs first
Measured: up to 5 years after treatment discontinuation
Disease control rate
Proportion of subjects in the efficacy population who achieve an Investigator-assessed confirmed CR, PR, or SD per RECIST 1.1
Measured: up to 5 years after treatment discontinuation
Progression-free survival
Date of first the administration of MILs™ - NSCLC until documented PD or death due to any cause, whichever occurs first
Measured: up to 5 years after treatment discontinuation
Overall survival
Duration from the date of administration of MILs™ - NSCLC until death due to any cause
Measured: up to 5 years after treatment discontinuation
Overall Response Rate (ORR) of MILs™ - NSCLC
Proportion of subjects with reduction in tumor burden of a predefined amount per RECIST 1.1
Measured: 24 months
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (pulse rate)
Pulse rate in beats/minute
Measured: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (weight)
Weight in pounds
Measured: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (blood pressure)
Systolic and diastolic blood pressure in mmHg
Measured: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (respiratory rate)
Respiratory rate in breaths/minute
Measured: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (temperature)
Termperature in Fahrenheit
Measured: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivo. with or w/o tadalafil by liver function (ALT/AST (U/L), albumin (g/dL), tot. bilirubin (mg/dL)), kidney function (creatinine (mg/dL) and endocrine function (T3 free and T4 free (ng/dL))
Clinical chemistry results will be summarized and changes from baseline provided
Measured: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil by cell count (e.g. RBC (10^6/uL), WBC (10^3/uL), absolute cell count (10^3/uL), Hct (%) and Hgb (g/dL)
Hematology results will be summarized and changes from baseline provided
Measured: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by APTT (seconds), fibrinogen (mg/dL), INR and protime (seconds)
Coagulation results will be summarized in data listings
Measured: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by urine appearance, color, pH, specific gravity and presence of blood, bilirubin, glucose, ketone, leukocyte esterase, nitrite, protein, urobilinogen
Urinalysis results will be summarized in data listings
Measured: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil by electrocardiograms (ECGs) assessed by Investigators as normal, abnormal clinically significant or abnormal not clinically significant
ECGs results will be summarized and changes from baseline provided
Measured: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil by physical examination with abnormalities reported as adverse events
Physical examinations will be performed by the Investigators and any new clinically significant or changes in medical conditions will be reported as adverse events
Measured: From ICF through 100 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Oct 2019
- Primary completion28 Oct 2021
- Study completion30 Nov 2021
Why it stopped: Resourcing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- In Part 1, approximately 3-6 subjects will be treated with MILs™ - NSCLC alone. Following Part 1, approximately 20 subjects will be treated with MILs™ - NSCLC plus nivolumab with or without tadalafil.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- WindMIL Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069936
- Sponsor's protocol ID
- CLN-P18001
- Status last verified
- Jul 2022
- First submitted
- 16 Aug 2019
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT04069936
- Acronym / sponsor ID
- CLN-P18001
- Conditions
- Non Small Cell Lung Cancer, Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Non-small Cell, Non Small Cell Lung Cancer Metastatic, NSCLC
- Keywords
- metastatic, locally advanced, lung cancer, non-small cell lung cancer, unresectable, NSCLC, cell therapy, autologous cell therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resourcing
- Enrolment
- 19 participants (actual)
- Lead sponsor
- WindMIL TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will examine the safety and efficacy of Marrow Infiltrating Lymphocytes-Non-Small Cell Lung Cancer (MILs™ - NSCLC) combined with nivolumab with or without tadalafil in subjects with locally advanced and unresectable and metastatic NSCLC who were refractory to, or have relapsed on, an anti-PD-1 containing regimen. MILs™ - NSCLC are an adoptive cell therapy product derived via the activation and expansion of bone marrow T cells. Subjects will have bone marrow harvested during the Screening Period which will be used to manufacture the MILs™ - NSCLC. The MILs™ - NSCLC will then be administered on Day 0. Nivolumab will be administered on Day 1 and will continue every four weeks until treatment discontinuation. Tadalafil will be administered on Day 1 and will continue daily until treatment discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In Part 1, approximately 3-6 subjects will be treated with MILs™ - NSCLC alone. Following Part 1, approximately 20 subjects will be treated with MILs™ - NSCLC plus nivolumab with or without tadalafil.
| Arm | Type | Receives |
|---|---|---|
| MILs™ - NSCLC plus nivolumab with or without tadalafil | Experimental | Biological: MILs™ - NSCLC, Biological: nivolumab, Drug: tadalafilLocally advanced and unresectable and metastatic NSCLC subjects previously treated with anti-programmed cell death-1 (PD-1) will be treated with MILs™ - NSCLC plus nivolumab with or without tadalafil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Locally advanced and unresectable, or metastatic NSCLC.
- Histologically or cytologically confirmed, either squamous or non-squamous NSCLC.
- Measurable disease as per RECIST 1.1
- Willingness to undergo bone marrow aspiration (BMA).
Key exclusion criteria (18 listed)
- Insufficient activation/expansion of T cells or other problems with the subject's MILs™ - NSCLC product which would prohibit administration.
- Major surgical procedure within 7 days of the first dose of lymphodepletion treatment.
- Prior malignancy active within the previous 3 years from date of BMA collection except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- Subjects with symptomatic uncontrolled brain metastases requiring treatment with steroids or anti-seizure medications within 28 days prior to the BMA are excluded. However, participants with brain metastases that have been previously treated and are stable on subsequent scan(s) are allowed and subjects with untreated possible brain metastases that are new at the time of screening and are < 1 cm and asymptomatic are allowed. Subjects with asymptomatic untreated CNS disease may undergo BMA prior to treatment of such disease.
- Infection requiring treatment with intravenous antibiotics, antifungal, or antiviral agents within 7 days prior to the BMA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MILs™ - NSCLCAlso: Marrow Infiltrating LymphocytesTo evaluate the safety of MILs™ - NSCLC alone in subjects with locally advanced and unresectable or metastatic NSCLC | Biological | MILs™ - NSCLC plus nivolumab with or without tadalafil |
| nivolumabTo evaluate the efficacy of MILs™ - NSCLC in combination with nivolumab in subjects with locally advanced and unresectable or metastatic NSCLC | Biological | MILs™ - NSCLC plus nivolumab with or without tadalafil |
| tadalafilTo evaluate the efficacy of MILs™ - NSCLC in combination with nivolumab with or without tadalafil in subjects with locally advanced and unresectable or metastatic NSCLC | Drug | MILs™ - NSCLC plus nivolumab with or without tadalafil |
Primary outcome
Adverse Events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0
Time frame: From ICF through 100 days after the last dose of study treatment
Incidence, intensity, and type of AE
Serious Adverse Events per NCI-CTCAE version 5.0
Time frame: From ICF through 100 days after the last dose of study treatment
Incidence, intensity, and type of SAE
Overall Response Rate (ORR) of MILs™ - NSCLC in combination with nivolumab with or without tadalafil
Time frame: 24 months
Proportion of subjects with reduction in tumor burden of a predefined amount per RECIST 1.1
16 secondary outcomes
Duration of response
Time frame: up to 5 years after treatment discontinuation
Disease control rate
Time frame: up to 5 years after treatment discontinuation
Progression-free survival
Time frame: up to 5 years after treatment discontinuation
Overall survival
Time frame: up to 5 years after treatment discontinuation
Overall Response Rate (ORR) of MILs™ - NSCLC
Time frame: 24 months
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (pulse rate)
Time frame: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (weight)
Time frame: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (blood pressure)
Time frame: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (respiratory rate)
Time frame: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by vital signs (temperature)
Time frame: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivo. with or w/o tadalafil by liver function (ALT/AST (U/L), albumin (g/dL), tot. bilirubin (mg/dL)), kidney function (creatinine (mg/dL) and endocrine function (T3 free and T4 free (ng/dL))
Time frame: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil by cell count (e.g. RBC (10^6/uL), WBC (10^3/uL), absolute cell count (10^3/uL), Hct (%) and Hgb (g/dL)
Time frame: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by APTT (seconds), fibrinogen (mg/dL), INR and protime (seconds)
Time frame: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil as assessed by urine appearance, color, pH, specific gravity and presence of blood, bilirubin, glucose, ketone, leukocyte esterase, nitrite, protein, urobilinogen
Time frame: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil by electrocardiograms (ECGs) assessed by Investigators as normal, abnormal clinically significant or abnormal not clinically significant
Time frame: From ICF through 100 days after the last dose of study treatment
Safety of MILs™ - NSCLC alone and in combination with nivolumab with or without tadalafil by physical examination with abnormalities reported as adverse events
Time frame: From ICF through 100 days after the last dose of study treatment
Results and safety
The study was stopped early (reason given: Resourcing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MILs™ - NSCLC, nivolumab and tadalafil in people with Non Small Cell Lung Cancer and Lung Cancer, run by WindMIL Therapeutics at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Resourcing). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0 (time frame: From ICF through 100 days after the last dose of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.