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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights
CheckMate 227 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.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.
CheckMate 227 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
CheckMate 227 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
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 • 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
CheckMate 227 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
~2670
Cisplatin
2013
Completed Phase 3
~1940
Nivolumab
2014
Completed Phase 3
~4750
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
2,638 Previous Clinical Trials
4,125,766 Total Patients Enrolled
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
91,775 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for hepatitis B, hepatitis C, or HIV.My lung cancer is advanced or has come back and I haven't had any cancer treatment before.My cancer has been tested for PD-L1.I do not have untreated brain metastases.My cancer can be measured on scans according to specific criteria.I do not have an active autoimmune disease.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Nivolumab
- Group 2: Arm B: Nivolumab + Ipilimumab
- Group 3: Arm D: Platinum doublet chemotherapy
- Group 4: Arm C: Nivolumab + Platinum doublet chemotherapy
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.
What are some of the most common conditions that Nivolumab is used to treat?
"Nivolumab can be used to fight three different types of cancer: metastatic bladder cancer, small cell lung cancer, and advanced testicular cancer."
Answered by AI
What harmful effects has Nivolumab been known to cause in people?
"There is some data to support the efficacy of Nivolumab, as this is a Phase 3 trial. Furthermore, there have been multiple rounds of data supporting safety, thus our team has given it a score of 3."
Answered by AI
Is this trial active in a number of locations across Canada?
"In total, this trial is running at 31 different institutions, three of which are Local Institution - 0103 in Edmonton, Alberta, Local Institution - 0011 in Salt Lake City, Utah, and Local Institution - 0302 in Quebec, Pennsylvania."
Answered by AI
Are people with the required health qualifications able to sign up for this research project at this time?
"Unfortunately, this trial is no longer recruiting. The posting date was 8/5/2015, and the most recent update was on 10/25/2022. However, there are 2079 trials for patients with lung cancer and 2479 trials for Nivolumab that are actively recruiting."
Answered by AI
Can you please list other studies that have used Nivolumab?
"Nivolumab was first studied in 1997 and, since then, 3172 clinical trials have been completed. There are 2479 ongoing studies, many of which are based in Edmonton, Alberta."
Answered by AI
How many people total have signed up for this clinical trial?
"This study is not looking for any more participants at the moment. The trial was first posted on August 5th, 2015 and was last updated on October 25th, 2022. If you're interested in other trials, there are 2079 clinical trials for lung cancer and 2479 trials for Nivolumab that are currently recruiting patients."
Answered by AI
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