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Chemotherapy

Immunotherapy + Chemotherapy for Lung Cancer (CheckMate 816 Trial)

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Lung function capacity capable of tolerating the proposed lung surgery
Available tissue of primary lung tumor
Must not have
Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
Presence of locally advanced, inoperable or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to a median of 30 months after randomization.
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing a new way to treat lung cancer that may be more effective and have fewer side effects than the current standard of care.

Who is the study for?
This trial is for people with early-stage IB-IIIA operable non-small cell lung cancer (NSCLC) who have good lung function and can handle surgery. They should be relatively healthy, which means having an ECOG Performance Status of 0-1. Those with advanced inoperable or metastatic disease, autoimmune diseases, or previous treatments targeting T cell pathways cannot join.
What is being tested?
The study tests the safety and effectiveness of adding Nivolumab to chemotherapy before surgery compared to just chemotherapy alone. It also examines how safe and effective it is to combine Nivolumab with Ipilimumab versus the standard treatment for resectable NSCLC.
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), fatigue, nausea, breathing difficulties, and potential infusion reactions during administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lungs are strong enough for surgery.
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I have a sample of my lung tumor available.
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I am fully active or can carry out light work.
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My lung cancer is in early stage IB-IIIA and can be operated on.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with drugs that boost the immune system.
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My cancer cannot be removed by surgery and may have spread.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to a median of 30 months after randomization.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to a median of 30 months after randomization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-Free Survival (EFS)
Pathologic Complete Response (pCR) Rate
Secondary study objectives
Major Pathologic Response (MPR) Rate
Overall Survival (OS)
Time to Death or Distant Metastases (TTDM)

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%
0%
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

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab plus platinum doublet chemotherapyExperimental Treatment6 Interventions
Specified dose on specified days
Group II: Nivolumab plus IpilimumabExperimental Treatment2 Interventions
Specified dose on specified days
Group III: Platinum doublet chemotherapyActive Control7 Interventions
Specified dose on specified days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5450
Ipilimumab
2015
Completed Phase 3
~3420
Nivolumab
2015
Completed Phase 3
~4010
Cisplatin
2013
Completed Phase 3
~3120
Gemcitabine
2017
Completed Phase 3
~1920
Pemetrexed
2014
Completed Phase 3
~5550
Carboplatin
2014
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

Ono Pharmaceutical Co. LtdIndustry Sponsor
174 Previous Clinical Trials
95,433 Total Patients Enrolled
Bristol-Myers SquibbLead Sponsor
2,691 Previous Clinical Trials
4,097,083 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02998528 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Platinum doublet chemotherapy, Nivolumab plus platinum doublet chemotherapy, Nivolumab plus Ipilimumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02998528 — Phase 3
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02998528 — Phase 3
~58 spots leftby Dec 2025
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