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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Assess Adverse Events
Overall Survival (OS)
Time to Metastatic Disease
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%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Rash
14%
Hyponatraemia
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%
Muscular weakness
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
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%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Chills
7%
Blood alkaline phosphatase increased
7%
Hypertension
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest 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%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Bone pain
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Neoplasm progression
1%
Circulatory collapse
1%
Atrial flutter
1%
Bronchial obstruction
1%
Hypercalcaemia
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
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
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670
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
369 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,409 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of HIV or chronic hepatitis B or C.I have an active tuberculosis infection.I've had lung cancer treatment but not more than standard chemoradiation or 2 extra cycles.My cancer has not spread to other parts of my body (not stage IV).I have been mostly active and able to carry out all my pre-disease activities up to 2 weeks ago.I have another type of cancer that is currently active.I have lung disease or had lung inflammation treated with steroids.I have an immune system disorder or have been on steroids or other immune-weakening drugs recently.My lung cancer has been confirmed by lab tests.I finished my last cancer treatment 1-56 days ago and have recovered from major side effects.My lung cancer is at stage IIIA or IIIB and cannot be removed with surgery.I completed treatment with specific drugs and radiation for my cancer.My organs are functioning well.I have an autoimmune disease that needed treatment in the last 3 months or have a history of severe autoimmune disease.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I can follow the study's procedures for its duration.I do not have any active infections.You are allergic to nivolumab or ipilimumab, or any of the ingredients in these medications.My cancer has spread to my brain.I am using a highly effective contraceptive method.
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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2
- Group 2: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active 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 scope of participants in this research endeavor?
"At this moment in time, no new participants are being admitted to the study. Per clinicaltrials.gov records, it was initially posted on September 15th 2017 and last modified on August 31st 2022. If you seek alternative trials that may suit your needs better, 1949 studies related to lung cancer and 765 for Nivolumab have been recorded as actively recruiting patients."
Answered by AI
Has Nivolumab been given the green light by federal regulators?
"The safety of Nivolumab was scored as a 2, given the Phase 2 trial data that supports its security but lacks evidence of efficacy."
Answered by AI
Is there a history of Nivolumab used for medical research?
"At present, there are 765 active investigations involving Nivolumab with 86 of those studies in their final stage. Primarily hosted in Pittsburgh, PA – though there exist 42,750 locations worldwide conducting clinical trials centered on this drug."
Answered by AI
In what areas is this research taking place?
"This clinical trial is being conducted out of Michigan State University, the University of Nebraska Medical Center, and Rutgers Cancer Institute in New jersey. In addition to these 3 sites, there are a dozen other locations hosting this study."
Answered by AI
To what afflictions is Nivolumab typically prescribed?
"Nivolumab is a potential treatment for those who have experienced anti-angiogenic interventions, advanced malignant tumours, or irresectable melanoma."
Answered by AI
Are there any vacancies remaining in this clinical trial?
"Unfortunately, recruitment for this clinical trial has concluded. It was initially opened on the 15th of September 2017 and ended on the 31st August 2022. However, if you are looking to join another study, there is currently 1949 studies recruiting patients with lung cancer and 765 trials that involve Nivolumab actively seeking participants."
Answered by AI
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