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Cell Therapy

nivolumab for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by WindMIL Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from icf through 100 days after the last dose of study treatment
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that could help those who haven't responded to other treatments.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5.0
Overall Response Rate (ORR) of MILs™ - NSCLC in combination with nivolumab with or without tadalafil
Serious Adverse Events per NCI-CTCAE version 5.0
Secondary outcome measures
Disease control rate
Duration of response
Non-Small Cell Lung Carcinoma
+13 more

Side effects data

From 2021 Phase 3 trial • 1844 Patients • NCT03068455
38%
Fatigue
37%
Diarrhoea
37%
Pruritus
29%
Headache
28%
Rash
24%
Hypothyroidism
24%
Nausea
20%
Hyperthyroidism
18%
Arthralgia
18%
Cough
18%
Asthenia
15%
Alanine aminotransferase increased
13%
Lipase increased
13%
Pyrexia
12%
Constipation
12%
Aspartate aminotransferase increased
12%
Decreased appetite
12%
Nasopharyngitis
11%
Abdominal pain
11%
Dry mouth
11%
Vomiting
11%
Myalgia
10%
Hypophysitis
10%
Insomnia
10%
Back pain
9%
Amylase increased
8%
Dyspnoea
8%
Upper respiratory tract infection
7%
Dizziness
6%
Adrenal insufficiency
6%
Abdominal pain upper
6%
Infusion related reaction
6%
Hyperglycaemia
6%
Oropharyngeal pain
6%
Blood creatine phosphokinase increased
6%
Influenza like illness
5%
Vitiligo
5%
Hypertension
5%
Pain in extremity
3%
Colitis
3%
Anxiety
2%
Immune-mediated enterocolitis
2%
Autoimmune hepatitis
2%
Basal cell carcinoma
2%
Malignant neoplasm progression
1%
Autoimmune colitis
1%
Squamous cell carcinoma
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Erysipelas
1%
Pneumonia
1%
Melanoma recurrent
1%
Pneumonitis
1%
Sarcoidosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Ipi
Arm B: Nivo

Trial Design

1Treatment groups
Experimental Treatment
Group I: MILs™ - NSCLC plus nivolumab with or without tadalafilExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Tadalafil
FDA approved

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,445 Total Patients Enrolled
WindMIL TherapeuticsLead Sponsor
2 Previous Clinical Trials
6 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2019. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04069936.
~3 spots leftby Apr 2025
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