Nivolumab for Small Cell Lung Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Small Cell Lung Carcinoma+7 More
Nivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination treatment for lung cancer patients who have not responded to other treatments.

Eligible Conditions
  • Small Cell Lung Carcinoma
  • Small Cell Lung Cancer (SCLC)
  • Thoracic Neoplasms
  • Non-small Cell Lung Cancer
  • Thymic Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Small Cell Lung Carcinoma

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Up to 2 years

At 1 year
Objective response rate as related to PD-L1 status measured as < 1%, 1-49%, and > 50%.
Overall survival
At 28 days
Phase II recommended combination dose per Common Terminology Criteria for Adverse Events (CTCAE) criteria version 4.03
Up to 1 year
Phase II best response
Up to 1 year.
Phase II best response per Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 2 years
Disease control rate
Progression-free survival

Trial Safety

Safety Progress

1 of 3

Other trials for Small Cell Lung Carcinoma

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

1 Treatment Group

Treatment (vorolanib, nivolumab)
1 of 1
Experimental Treatment

88 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 1 & 2

Treatment (vorolanib, nivolumab)Experimental Group · 2 Interventions: Nivolumab, VEGFR/PDGFR Dual Kinase Inhibitor X-82 · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,481 Previous Clinical Trials
3,919,784 Total Patients Enrolled
26 Trials studying Small Cell Lung Carcinoma
24,077 Patients Enrolled for Small Cell Lung Carcinoma
Xcovery Holdings, INCUNKNOWN
Vanderbilt-Ingram Cancer CenterLead Sponsor
202 Previous Clinical Trials
64,424 Total Patients Enrolled
4 Trials studying Small Cell Lung Carcinoma
111 Patients Enrolled for Small Cell Lung Carcinoma
Leora Horn, MDPrincipal InvestigatorVanderbilt-Ingram Cancer Center
3 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Small Cell Lung Carcinoma
50 Patients Enrolled for Small Cell Lung Carcinoma
Kathryn Beckermann, MDPrincipal Investigator - Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.