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Immunotherapy for Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by Greg Durm, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG Performance Status of 0 or 1 within 14 days prior to registration
Histological or cytological confirmation of NSCLC
Must not have
History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
Has a known history of active TB (Bacillus Tuberculosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether adding immunotherapy to standard treatment can help patients with unresectable stage III NSCLC.

Who is the study for?
This trial is for adults with stage IIIA/IIIB non-small cell lung cancer that can't be removed by surgery. Participants must have finished chemoradiation, be in good physical condition (ECOG 0 or 1), and not have other active cancers or severe autoimmune diseases. They should not be pregnant, breastfeeding, or planning to conceive during the trial and must use effective contraception.
What is being tested?
The study is testing two types of immunotherapy after standard treatment: one group will receive Nivolumab alone while another will get a combination of Nivolumab and Ipilimumab. It's randomized, meaning patients are placed into groups by chance.
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune-related side effects like inflammation in various organs, skin rash, hormone gland problems (like thyroid issues), digestive tract symptoms (like diarrhea), liver inflammation, fatigue, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been mostly active and able to carry out all my pre-disease activities up to 2 weeks ago.
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My lung cancer has been confirmed by lab tests.
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I finished my last cancer treatment 1-56 days ago and have recovered from major side effects.
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My lung cancer is at stage IIIA or IIIB and cannot be removed with surgery.
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I completed treatment with specific drugs and radiation for my cancer.
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I am 18 years old or older.
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I can follow the study's procedures for its duration.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of HIV or chronic hepatitis B or C.
Select...
I have an active tuberculosis infection.
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My cancer has not spread to other parts of my body (not stage IV).
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I have another type of cancer that is currently active.
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I have lung disease or had lung inflammation treated with steroids.
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My cancer has spread to my brain.
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I have an autoimmune disease that needed treatment in the last 3 months or have a history of severe autoimmune disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Assess Adverse Events
Overall Survival (OS)
Time to Metastatic Disease

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment2 Interventions
Nivolumab 240mg IV every 2 weeks PLUS Ipilimumab 1mg/kg IV every 6 weeks for up to 4 cycles (12 doses Nivolumab and 4 doses of Ipilimumab)
Group II: Arm 1Experimental Treatment1 Intervention
Nivolumab 480mg IV every 4 weeks for up to 6 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Ipilimumab
2015
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Greg Durm, MDLead Sponsor
3 Previous Clinical Trials
286 Total Patients Enrolled
Big Ten Cancer Research ConsortiumOTHER
10 Previous Clinical Trials
340 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,098,966 Total Patients Enrolled
Greg Durm, M.D.Study Chair - Indiana University Health Simon Cancer Center
Big Ten Cancer Research Consortium
1 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT03285321 — Phase 2
Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03285321 — Phase 2
Lung Cancer Research Study Groups: Arm 2, Arm 1
Lung Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03285321 — Phase 2
~13 spots leftby Dec 2025
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