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Nivolumab for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-Small Cell Lung Cancer+1 MoreNivolumab - Drug
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

Study Summary

This trial's response rate was 36%.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Epigenetic Therapy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
PRO1184
1
Vamorolone
1
PQ912

Study Objectives

1 Primary Β· 4 Secondary Β· Reporting Duration: 2 years

2 years
Objective Response
Overall survival
Progression free survival
Safety and tolerability as assessed by number of participants with adverse events
Time to Progression

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
PRO1184
2
Vamorolone
2
PQ912

Side Effects for

NIVOLUMAB 3 mg/kg
38%Fatigue
29%Nausea
28%Decreased appetite
25%Cough
25%Diarrhoea
24%Dyspnoea
20%Vomiting
19%Constipation
14%Anaemia
14%Weight decreased
13%Malignant neoplasm progression
13%Aspartate aminotransferase increased
13%Arthralgia
13%Back pain
13%Pruritus
12%Pyrexia
12%Rash
11%Oedema peripheral
10%Dizziness
10%Myalgia
10%Productive cough
10%Abdominal pain
9%Non-cardiac chest pain
9%Alanine aminotransferase increased
9%Hypoalbuminaemia
9%Hyponatraemia
9%Headache
8%Asthenia
7%Hypothyroidism
7%Upper respiratory tract infection
7%Hypokalaemia
7%Musculoskeletal pain
6%Insomnia
6%Chills
6%Nasopharyngitis
6%Lymphocyte count decreased
6%Blood alkaline phosphatase increased
6%Hyperglycaemia
6%Musculoskeletal chest pain
6%Pain in extremity
6%Haemoptysis
6%Dry skin
6%Dyspepsia
5%Dysgeusia
5%Hypomagnesaemia
5%Rash maculo-papular
4%Pneumonia
4%Blood creatinine increased
4%Muscular weakness
3%Stomatitis
3%Chest pain
3%Hypophosphataemia
3%Dysphonia
3%Pneumonitis
2%Pleural effusion
2%Pulmonary embolism
2%Mucosal inflammation
2%Peripheral sensory neuropathy
2%Alopecia
2%Lung infection
2%Pericardial effusion malignant
2%Epistaxis
1%Acute coronary syndrome
1%Adrenal insufficiency
1%General physical health deterioration
1%Hypersensitivity
1%Urinary tract infection
1%Hip fracture
1%Infusion related reaction
1%Gamma-glutamyltransferase increased
1%Dehydration
1%Hypercalcaemia
1%Pathological fracture
1%Malignant pleural effusion
1%Cancer pain
1%Lung neoplasm malignant
1%Cerebrovascular accident
1%Confusional state
1%Metastases to spine
1%Syncope
1%Chronic obstructive pulmonary disease
1%Renal failure
1%Pneumothorax
1%Respiratory failure
1%Pulmonary haemorrhage
1%Deep vein thrombosis
1%Lacrimation increased
1%Neutropenia
1%Thrombocytopenia
1%Platelet count decreased
1%Neutrophil count decreased
1%Colitis
1%Cholecystitis acute
1%Sepsis
1%Lower respiratory tract infection
1%Metastases to central nervous system
1%Tumour pain
1%Seizure
1%White blood cell count decreased
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the NIVOLUMAB 3 mg/kg ARM group. Side effects include: Fatigue with 38%, Nausea with 29%, Decreased appetite with 28%, Cough with 25%, Diarrhoea with 25%.

Trial Design

4 Treatment Groups

Arm D
1 of 4
Arm C
1 of 4
Arm E
1 of 4
Arm F
1 of 4

Experimental Treatment

101 Total Participants Β· 4 Treatment Groups

Primary Treatment: Nivolumab Β· No Placebo Group Β· Phase 2

Arm DExperimental Group Β· 3 Interventions: Azacitidine, Entinostat, Nivolumab Β· Intervention Types: Drug, Drug, Drug
Arm C
Drug
Experimental Group Β· 1 Intervention: Nivolumab Β· Intervention Types: Drug
Arm EExperimental Group Β· 3 Interventions: Azacitidine, Entinostat, Nivolumab Β· Intervention Types: Drug, Drug, Drug
Arm FExperimental Group Β· 3 Interventions: Azacitidine, Entinostat, Nivolumab Β· Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Entinostat
Not yet FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Syndax PharmaceuticalsIndustry Sponsor
40 Previous Clinical Trials
2,283 Total Patients Enrolled
Rhone-Poulenc RorerIndustry Sponsor
5 Previous Clinical Trials
149 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,501 Previous Clinical Trials
3,928,075 Total Patients Enrolled
CelgeneIndustry Sponsor
625 Previous Clinical Trials
173,048 Total Patients Enrolled
Stand Up To CancerOTHER
45 Previous Clinical Trials
33,201 Total Patients Enrolled
Rising Tide FoundationOTHER
10 Previous Clinical Trials
1,828 Total Patients Enrolled
Syndax Pharmaceuticals, Inc.UNKNOWN
4 Previous Clinical Trials
74 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
537 Previous Clinical Trials
31,200 Total Patients Enrolled
Julie Brahmer, MDPrincipal InvestigatorJohns Hopkins University
4 Previous Clinical Trials
227 Total Patients Enrolled

Eligibility Criteria

Age 18 - 100 Β· All Participants Β· 10 Total Inclusion Criteria

Mark β€œYes” if the following statements are true for you:
Children and adolescents under 18 years of age are excluded from this study.
You are able to understand the nature and purpose of the study and the risks and benefits of participating in the study.
You have a good performance status.
Patients with EGFR or ALK wild type tumors are eligible if they have received no more than two prior chemotherapy-based lines of therapy for advanced or metastatic NSCLC.
References

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