What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) using immune checkpoint inhibitors such as nivolumab, pembrolizumab, and atezolizumab can cause a range of side effects. These include immune-related adverse events like pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Severe side effects may include grade 3 or higher toxicities such as pneumonia, chronic obstructive pulmonary disease, and severe immune-related reactions. Fatal adverse reactions, although rare, can occur and include conditions like pulmonary embolism, acute myocardial infarction, and sepsis. Management of these side effects often involves withholding the immunotherapy and administering immunosuppressive treatments.

What prior FDA approvals exist?

Several immunotherapy drugs have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Nivolumab, a PD-1 inhibitor, is approved for use after surgery and chemotherapy in treating patients with stage IB-IIIA NSCLC. Pembrolizumab, another PD-1 inhibitor, has shown efficacy in combination with chemotherapy for advanced squamous NSCLC, improving overall survival (OS) and progression-free survival (PFS). Atezolizumab, a PD-L1 inhibitor, is approved for front-line treatment in patients with high PD-L1 expression, demonstrating improved OS and PFS compared to chemotherapy. Cemiplimab, also a PD-1 inhibitor, has shown improved OS and PFS in patients with advanced NSCLC with high PD-L1 expression. These approvals highlight the effectiveness of immunotherapy in enhancing the immune system's ability to target and inhibit tumor growth in NSCLC.

What other types of research exist?

Promising alternatives to Nivolumab for NSCLC patients include Pembrolizumab, which can be used alone or in combination with chemotherapy, and Durvalumab, particularly when combined with Tremelimumab and chemotherapy. These alternatives have shown efficacy in clinical trials and offer different therapeutic options based on PD-L1 expression levels and patient-specific factors.

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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

No Placebo-Only Group

Pivotal Trial

Summary

This trial studies how well nivolumab works in treating patients with non-small cell lung cancer. Nivolumab is an immunotherapy drug that helps the immune system attack cancer cells. The goal is to see if it can prevent the cancer from coming back. Nivolumab has shown efficacy in treating various malignancies, including 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disease-free survival (DFS)

Overall survival (OS)

Secondary study objectives

Incidence of adverse events

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

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.

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

~11580

Positron Emission Tomography

2011

Completed Phase 2

~2200

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790

Nivolumab

2015

Completed Phase 3

~4010

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapies and chemotherapies. Immunotherapies, such as nivolumab, are monoclonal antibodies that target immune checkpoint pathways like PD-1/PD-L1. By inhibiting these pathways, nivolumab enhances the immune system's ability to recognize and attack cancer cells, thereby inhibiting tumor growth and spread. Chemotherapies, on the other hand, use cytotoxic drugs to kill rapidly dividing cancer cells, but they also affect normal cells, leading to broader side effects. The significance of these treatments for NSCLC patients lies in their ability to improve overall survival and progression-free survival, offering hope for better management of this aggressive cancer.

Comparative beneficiary effects of immunotherapy against chemotherapy in patients with advanced NSCLC: Meta-analysis and systematic review.Focus on Nivolumab in NSCLC.