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Chemotherapy

Immunotherapy for Lung Cancer (CheckMate 227 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
Subjects with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy
Subjects must have programmed death-ligand 1 (PD -L1) immunohistochemical (IHC) testing, with results, performed by the central lab during the Screening period
Must not have
Subjects with untreated Central nervous system (CNS) metastases are excluded
Subjects with an active, known or suspected autoimmune disease are excluded
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether Nivolumab, or a combination of Nivolumab and Ipilimumab, or Nivolumab and Platinum-Doublet Chemotherapy can help people with advanced lung cancer live longer without their disease getting worse, or improve overall survival.

Who is the study for?
This trial is for adults with Stage IV or recurrent non-small cell lung cancer (NSCLC) who haven't had prior systemic anticancer therapy. They must have a specific protein (PD-L1) on their tumor cells and be in good physical condition, able to perform daily activities with minimal assistance. People with untreated brain metastases, active autoimmune diseases, or acute/chronic hepatitis B/C or HIV are not eligible.
What is being tested?
The study tests if Nivolumab alone, combined with Ipilimumab, or along with Platinum-Doublet Chemotherapy (like Cisplatin or Carboplatin), can extend the time patients live without disease progression compared to standard chemotherapy drugs like Pemetrexed and Gemcitabine.
What are the potential side effects?
Nivolumab and Ipilimumab may cause immune-related side effects such as inflammation of organs, skin rash, hormone gland problems; while chemotherapies can lead to nausea, hair loss, fatigue and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is advanced or has come back and I haven't had any cancer treatment before.
Select...
My cancer has been tested for PD-L1.
Select...
My cancer can be measured on scans according to specific criteria.
Select...
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have untreated brain metastases.
Select...
I do not have an active autoimmune disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects
Objective response rate (ORR)

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

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

4Treatment groups
Experimental Treatment
Group I: Arm D: Platinum doublet chemotherapyExperimental Treatment5 Interventions
Chemotherapy administered on specified days of IV chemotherapy
Group II: Arm C: Nivolumab + Platinum doublet chemotherapyExperimental Treatment6 Interventions
Nivolumab + Platinum doublet chemotherapy (IV) dose as specified
Group III: Arm B: Nivolumab + IpilimumabExperimental Treatment2 Interventions
Nivolumab + Ipilimumab IV as specified
Group IV: Arm A: NivolumabExperimental Treatment1 Intervention
Nivolumab intravenously (IV) as specified
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5810
Nivolumab
2014
Completed Phase 3
~5220
Ipilimumab
2014
Completed Phase 3
~3140
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~3120
Gemcitabine
2017
Completed Phase 3
~1920
Pemetrexed
2014
Completed Phase 3
~5550

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,680 Previous Clinical Trials
4,122,155 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
171 Previous Clinical Trials
92,956 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT02477826 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm A: Nivolumab, Arm B: Nivolumab + Ipilimumab, Arm D: Platinum doublet chemotherapy, Arm C: Nivolumab + Platinum doublet chemotherapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02477826 — Phase 3
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02477826 — Phase 3
~270 spots leftby Oct 2025
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