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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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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%

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%

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2015

Completed Phase 3

~3070

Nivolumab

FDA approved

Carboplatin

FDA approved