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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

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.Check my eligibility
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.See study design
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.
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My cancer has been tested for PD-L1.
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My cancer can be measured on scans according to specific criteria.
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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:
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I do not have untreated brain metastases.
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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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Progression-free Survival (PFS) as determined by blinded independent central review (BICR)
Secondary outcome measures
Disease related symptom improvement as measured by the Lung Cancer Symptom Score (LCSS) in all subjects
Objective response rate (ORR)

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
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%
Neutropenia
21%
Pyrexia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
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%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Hypothyroidism
9%
Abdominal pain upper
9%
Upper respiratory tract infection
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%
Chills
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Dry mouth
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Cardiac failure
2%
Malignant pleural effusion
2%
Sepsis
2%
Atrial fibrillation
2%
General physical health deterioration
2%
Adrenal insufficiency
1%
Neoplasm progression
1%
Cancer pain
1%
Confusional state
1%
Circulatory collapse
1%
Bronchial obstruction
1%
Pneumothorax
1%
Atrial flutter
1%
Ileus
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Pericardial effusion
1%
Femur fracture
1%
Pancytopenia
1%
Colitis
1%
Small intestinal obstruction
1%
Hypercalcaemia
1%
Syncope
1%
Pericardial effusion malignant
1%
Superior vena cava syndrome
1%
Gastrointestinal haemorrhage
1%
Lung cancer metastatic
1%
Performance status decreased
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

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
Ipilimumab
2014
Completed Phase 3
~2610
Cisplatin
2013
Completed Phase 3
~1940
Nivolumab
2014
Completed Phase 3
~4740
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~5250
Gemcitabine
2017
Completed Phase 3
~2070
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,652 Previous Clinical Trials
4,128,001 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
91,775 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
~25 spots leftby Aug 2024