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Immunotherapy for Lung Cancer (NA_00092076 Trial)

Phase 2
Waitlist Available
Led By Patrick Forde, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically proven non-small-cell lung cancer (core biopsy required)
Either a formalin fixed paraffin block or a minimum of fifteen 5-micron tissue sections (slides) of tumor biopsy sample must be available for biomarker evaluation (study pathologist must review for adequacy of sampling). This can be obtained from archived tissues, or from a new biopsy if needed
Must not have
Known positive history or positive test for Human Immunodeficiency Virus or Acquired ImmunoDeficiency Syndrome (AIDS)
Administration of chemotherapy or any other cancer therapy in the pre-operative period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

This trial will test a new cancer treatment involving two immunotherapy drugs. The trial will help researchers understand how the treatment affects the immune system and cancer cells.

Who is the study for?
This trial is for adults with high-risk resectable non-small cell lung cancer (NSCLC), who have good organ function and performance status. They must not be incarcerated, pregnant, or have other serious health issues like active infections or autoimmune diseases. Participants need to agree to use contraception and provide tissue samples for research.
What is being tested?
The study tests the safety of giving Nivolumab alone or with Ipilimumab before surgery in NSCLC patients. It also looks at how these drugs affect immune cells in tumors and blood. The goal is to inform future trials on immunotherapies for both early-stage and advanced lung cancer.
What are the potential side effects?
Nivolumab and Ipilimumab can cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems, digestive issues, respiratory symptoms, liver toxicity, kidney dysfunction, infusion reactions, fatigue and may increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer diagnosis was confirmed with a core biopsy.
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I can provide a sample of my tumor for testing, either from previous or new biopsies.
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I am fully active or can carry out light work.
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My lung function is good enough for surgery, confirmed by tests.
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I agree to use birth control during and up to 23 weeks after the study.
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My lung cancer is either squamous or non-squamous.
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My lung cancer is at a high risk stage but can potentially be removed for a cure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have tested positive for HIV/AIDS.
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I have received cancer treatment before surgery.
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My partner and I are not planning to use birth control.
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I have previously been treated with specific antibodies.
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I haven't taken steroids or immunosuppressants in the last 14 days.
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I am currently being treated for an infection or have tested positive for Hepatitis B or C.
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I have had lung problems that made it hard for me to breathe.
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My cancer has spread to my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety as Assessed by Number of Grade 3 and 4 Adverse Events
Safety as Measured by Number of Participants With Grade 3 and 4 Lab Abnormalities, as Defined by CTCAE v4.03
Secondary study objectives
Pathologic Response
Radiographic Response

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%
Cushingoid
10%
Tinnitus
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

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C- Nivolumab, Carboplatin, & PaclitaxelExperimental Treatment3 Interventions
Nivolumab 360 mg IV, Carboplatin AUC 5 or 6 IV, and Paclitaxel 175 or 200 mg/m2 IV every 21 days for 3 cycles prior to planned surgery on Day 0.
Group II: Arm B- NivolumabExperimental Treatment1 Intervention
Nivolumab administration: Three doses of nivolumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days.
Group III: Arm A- Nivolumab and IpilimumabExperimental Treatment2 Interventions
One dose of Nivolumab 3mg/kg IV \& Ipilimumab 1mg/kg will be administered to enrolled patients on Day-42, then 2 doses of Nivolumab 3mg/kg will be administered to enrolled patients on Day-28 and Day-14
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~3140
Nivolumab
FDA approved
Carboplatin
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
566 Previous Clinical Trials
33,337 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,606 Total Patients Enrolled
Patrick Forde, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
5 Previous Clinical Trials
1,558 Total Patients Enrolled

Media Library

Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT02259621 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Arm C- Nivolumab, Carboplatin, & Paclitaxel, Arm B- Nivolumab, Arm A- Nivolumab and Ipilimumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02259621 — Phase 2
Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT02259621 — Phase 2
~4 spots leftby Sep 2025
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