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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
NA_00092076 Trial 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.
NA_00092076 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
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.
NA_00092076 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
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 • NCT0204153357%
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%
Pyrexia
21%
Neutropenia
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%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
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%
Bronchitis
7%
Chills
7%
Hypertension
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Pericardial effusion malignant
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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
NA_00092076 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
~2620
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,861 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,475 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tested positive for HIV/AIDS.I have received cancer treatment before surgery.My partner and I are not planning to use birth control.I have previously been treated with specific antibodies.My health conditions won't interfere with the study drug's safety or results.My lung cancer diagnosis was confirmed with a core biopsy.I haven't taken steroids or immunosuppressants in the last 14 days.You are in prison or being held against your will for psychiatric or physical treatment.I am fully active or can carry out light work.I have an autoimmune disease that is not one of the exceptions listed.My blood and organ tests show normal function.My lung function is good enough for surgery, confirmed by tests.I agree to use birth control during and up to 23 weeks after the study.I can provide a sample of my tumor for testing, either from previous or new biopsies.I am currently being treated for an infection or have tested positive for Hepatitis B or C.I have had lung problems that made it hard for me to breathe.My lung cancer is either squamous or non-squamous.My cancer has spread to my brain.My lung cancer is at a high risk stage but can potentially be removed for a cure.I have cancer other than non-small cell lung cancer.Women who can have babies need to have a negative pregnancy test within two weeks before joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C- Nivolumab, Carboplatin, & Paclitaxel
- Group 2: Arm B- Nivolumab
- Group 3: Arm A- Nivolumab and Ipilimumab
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the mortality rate of Nivolumab?
"Nivolumab has received a safety rating of 2. This is due to the fact that this medication is still in Phase 2 of clinical trials, where there is some data supporting safety, but no evidence yet of efficacy."
Answered by AI
Could you tell me how many different areas this trial is being carried out in?
"Patients are being accepted at this clinical trial at Johnathan Spicer in Montréal, Quebec, Johns Hopkins at Bayview Medical Center in Baltimore, Maryland, and Swedish Cancer Insitute in Edmonds, Washington along with 6 other locations."
Answered by AI
What does the current research landscape look like for Nivolumab?
"Nivolumab was first studied in 1997 and, since then, there have been a total of 1781 completed clinical trials. Right now, in 2021, there are still 1910 active studies being conducted; many of these in the Canadian city of Montréal, Quebec."
Answered by AI
Does this study still need participants?
"That is correct, the online information from clinicaltrials.gov does show that this particular trial is looking for more individuals to join. This research was first publicized on September 1st, 2014 and had its most recent update on July 26th, 2029. In total, the study needs 45 people at 6 different locations."
Answered by AI
How many people have been chosen to participate in this research project?
"In order to run this clinical trial, 45 patients who match the specified inclusion criteria are needed. The study is being conducted at various sites, including Johnathan Spicer in Montréal, Quebec and Johns Hopkins at Bayview Medical Center in Baltimore, Maryland."
Answered by AI
What are the common indications for Nivolumab?
"Nivolumab is most often used to fight cancer, but it can also be employed to treat conditions like unresectable melanoma, squamous cell carcinoma, and high risk of recurrence."
Answered by AI
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