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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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Pathologic Response
Radiographic Response

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Hypothyroidism
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Dry mouth
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Cardiac failure
2%
Malignant pleural effusion
2%
Sepsis
2%
Atrial fibrillation
2%
General physical health deterioration
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Cancer pain
1%
Confusional state
1%
Circulatory collapse
1%
Bronchial obstruction
1%
Pneumothorax
1%
Atrial flutter
1%
Ileus
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Pericardial effusion
1%
Femur fracture
1%
Pancytopenia
1%
Colitis
1%
Small intestinal obstruction
1%
Hypercalcaemia
1%
Syncope
1%
Pericardial effusion malignant
1%
Superior vena cava syndrome
1%
Gastrointestinal haemorrhage
1%
Lung cancer metastatic
1%
Performance status decreased
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

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
Paclitaxel
FDA approved
Nivolumab
FDA approved
Carboplatin
FDA approved
Ipilimumab
2014
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
563 Previous Clinical Trials
33,285 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,710 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 Jul 2025
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