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Nivolumab for Non-Small Cell Lung Cancer (ANVIL Trial)
Phase 3
Waitlist Available
Led By Jamie E Chaft
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-CTLA4 monoclonal antibody)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
ANVIL Trial Summary
This trial is studying how well nivolumab works in treating patients with early-stage non-small cell lung cancer.
Who is the study for?
Adults who've had surgery for stage IB-IIIA non-small cell lung cancer and are done with any chemotherapy. They must not be pregnant, breastfeeding, or have certain viral infections. Their liver and kidney functions should be normal, they can't have autoimmune diseases except some like type I diabetes or controlled hypothyroidism, and no prior immune checkpoint inhibitor treatments.Check my eligibility
What is being tested?
The trial is testing if nivolumab (an immunotherapy drug) given after surgery and chemotherapy can help treat non-small cell lung cancer by boosting the body's immune response to attack cancer cells. It involves monitoring through scans like CT and PET, blood tests, and collecting biospecimens.See study design
What are the potential side effects?
Nivolumab may cause side effects such as fatigue, skin reactions, issues with hormone glands (like thyroid), inflammation in organs like lungs or intestines which might show up as breathing problems or diarrhea respectively.
ANVIL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I have never been treated with immune checkpoint inhibitors.
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I do not have untreated or active HIV, hepatitis B, or hepatitis C.
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I do not have lung conditions that could affect treatment side effects.
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My non-squamous tumor does not have specific EGFR or ALK genetic changes.
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I am 18 years old or older.
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I do not have any serious ongoing illnesses that would stop me from following the study's requirements.
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My lung cancer was surgically removed with clear margins.
ANVIL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-free survival (DFS)
Overall survival (OS)
Secondary outcome measures
Incidence of adverse events
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
ANVIL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (nivolumab)Experimental Treatment5 Interventions
Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET/CT throughout the trial and blood sample collection during screening and follow-up. Patients may undergo an ECHO as clinically indicated on study.
Group II: Arm II (observation)Active Control5 Interventions
Patients are followed serially with CT and/or PET/CT imaging for up to 1 year and then during follow-up. Patients also undergo blood sample collection during screening and follow-up. Patients may undergo an ECHO as clinically indicated on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Echocardiography
2013
Completed Phase 4
~11670
Positron Emission Tomography
2008
Completed Phase 2
~2240
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,250 Total Patients Enrolled
Jamie E ChaftPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had a chest CT scan within the last month showing no signs of disease spread.I am fully active or can carry out light work.You have not had allergic reactions to drugs similar to nivolumab.I am a woman who can have children and have tested negative for pregnancy recently.It has been at least 4 weeks since my surgery.I have never been treated with immune checkpoint inhibitors.I do not have an autoimmune disease, except for type I diabetes, hypothyroidism needing hormones, or skin issues not needing systemic treatment.Your liver function tests must be within a certain range.Your white blood cell count is at least 2000 cells per microliter within 2 weeks before the study starts.I do not have untreated or active HIV, hepatitis B, or hepatitis C.I do not have lung conditions that could affect treatment side effects.Your liver enzymes (AST and ALT) are not more than 2.5 times the normal limit.I have recovered from lung surgery and any cancer treatments I've had.My surgery and study enrollment happened close together.It's been over 10 months since I completed chemotherapy and radiation.My EGFR test is negative, and my ALK status is considered negative or untested, but I may still qualify for the trial based on other criteria.My non-squamous tumor does not have specific EGFR or ALK genetic changes.I am 18 years old or older.I had a chest CT scan within the last month showing no signs of disease spread.My non-squamous tumor does not have specific EGFR mutations or ALK rearrangement.My tumor's PD-L1 status has been tested as part of the ALCHEMIST-SCREEN protocol.I do not have any serious ongoing illnesses that would stop me from following the study's requirements.I have recovered from previous cancer treatments, except for hair loss, hearing issues, or nerve pain.I am not on high doses of steroids or other drugs that weaken my immune system.It's been 8 months since my last chemotherapy.Your hemoglobin level is at least 8 grams per deciliter within 2 weeks before starting the trial.Your platelet count is at least 100,000 per microliter within 2 weeks before starting the study.Your neutrophil count must be at least 1000 per microliter of blood within 2 weeks before starting the study.Your bilirubin levels must be within a certain range, unless you have a condition called Gilbert syndrome.My lung cancer was surgically removed with clear margins.I finished my chemotherapy more than 2 weeks ago, or 6 weeks for specific drugs, and 4 weeks for radiation.I haven't received chemotherapy in the last 3 months.Your kidney function, as measured by a blood test called serum creatinine, is within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (nivolumab)
- Group 2: Arm II (observation)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
For what medical conditions is Nivolumab generally prescribed?
"Malignant neoplasms are often treated with Nivolumab. Nivolumab can also help patients with unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma manage their condition."
Answered by AI
Are there any other experiments that have been done that are similar to this one involving Nivolumab?
"As of now, there are 752 Nivolumab trials in progress, 83 of which are in Phase 3. Most of these trials are situated in Ciudad de Mexico and Maryland, but Nivolumab trials are being conducted at 40,541 locations worldwide."
Answered by AI
Can you tell me how many hospitals are currently participating in this trial?
"This large-scale trial is currently underway at 100 hospitals, some of which include Spectrum Health Reed City Hospital, Saint James Community Hospital, and NEA Baptist Memorial Hospital."
Answered by AI
Are we still able to ask people to participate in this research project?
"No, this particular clinical trial is not recruiting patients at this time. Although the last update to the posting on clinicaltrials.gov was on September 23rd, 2022, the study is not presently looking for volunteers. There are, however, 4,511 other trials that are currently recruiting patients."
Answered by AI
Is this an innovative or cutting-edge study?
"There are 752 different ongoing clinical trials that are testing the effectiveness of nivolumab in 50 different countries. These trials began in 2010 and, to date, have involved over 24,000 patients."
Answered by AI
What have been the most serious side effects that have been reported with Nivolumab?
"There is already clinical evidence backing the safety of Nivolumab, which is why it received a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
What site did they apply to?
Loma Linda University Medical Center
Mercy Oncology Center
Cleveland Clinic Cancer Center Independence
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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