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Checkpoint Inhibitor
Combination Immunotherapy + Thoracic Radiotherapy for Small Cell Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Bradford A. Perez, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is studying a combination of ipilimumab and nivolumab with thoracic radiation therapy to see how well it works in treating patients with stage III-IV non-small cell lung cancer.
Eligible Conditions
- Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase I: Confirmation of Recommended Phase II Dose
Phase II: Progression Free Survival (PFS)
Secondary outcome measures
Overall Survival (OS)
Side effects data
From 2023 Phase 1 & 2 trial • 21 Patients • NCT0304359948%
Esophagitis
48%
Cough
38%
Fever
33%
Diarrhea
33%
Nausea
33%
Neoplasms benign, malignant and unspecified -Other
33%
Dizziness
33%
Anorexia
29%
Lung Infection
29%
Fatigue
29%
Vomiting
29%
Dyspnea
29%
Dry Mouth
29%
Generalized Muscle Weakness
24%
Thromboembolic event
24%
Dysphagia
24%
Pruritus
24%
Death
24%
Pneumonitis
24%
Abdominal Pain
24%
Insomnia
24%
Pain
24%
Arthralgia
24%
Dehydration
19%
Edema Limbs
19%
Constipation
19%
Headache
19%
Hypoxia
19%
Hyponatremia
19%
Back Pain
19%
Anxiety
19%
Depression
14%
Anemia
14%
Hypothyroidism
14%
Cognitive Disturbance
14%
Productive Cough
10%
Platelet count decreased
10%
Memory impairment
10%
Peripheral sensory neuropathy
10%
Nasal congestion
10%
Colitis
10%
Infections and Investigations- Other
10%
Chills
10%
Acute kidney injury
10%
Gastroesophageal reflux disease
10%
Myalgia
10%
Sinus tachycardia
10%
Urinary retention
10%
Blood bilirubin increased
10%
Cognitive disturbance
10%
Confusion
10%
COPD Exacerbation
10%
Urinary Tract Infection
10%
Hypotension
10%
Flu like symptoms
10%
Rash, erythematous
5%
Arthritis
5%
Toothache
5%
Stroke
5%
Dysarthria
5%
Pericardial effusion
5%
Esophageal infection
5%
Bronchial infection
5%
Gastrointestinal disorders - Other
5%
Infusion related reaction
5%
Sinus bradycardia
5%
Urinary frequency
5%
Paresthesia
5%
Muscle weakness lower limb
5%
Gynecomastia
5%
Neck Pain
5%
Muscle weakness - lower limb
5%
Gait Disturbance
5%
Dermatitis Radiation
5%
Hearing impaired
5%
Vertigo
5%
Breast Pain
5%
Eye Disorders - Other
5%
Urosepsis
5%
Sepsis
5%
Alanine aminotransferase increased
5%
Aspartate aminotransferase
5%
Weight Loss
5%
SIADH
5%
Hypertension
5%
Chest Wall Pain
5%
Allergic Reaction
5%
Pleural effusion
5%
Hypomagnesemia
5%
Abdominal distension
5%
Hypokalemia
5%
Hoarseness
5%
Erythema
5%
Metabolism and Nutrition disorders - Other
5%
Metabolism and nutrition disorders -Other
5%
Generalized muscle weakness
5%
Dysgeusia
5%
Aspartate aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy
Trial Design
1Treatment groups
Experimental Treatment
Group I: Combination TherapyExperimental Treatment3 Interventions
Consolidative Ipilimumab and Nivolumab with Thoracic Radiotherapy after Platinum Based Chemotherapy. Radiotherapy, followed by a 14 to 21 day break between radiotherapy and the beginning of study drug treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thoracic Radiation Therapy
2017
Completed Phase 2
~30
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,471 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,493 Total Patients Enrolled
Bradford A. Perez, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a lung disease that causes symptoms or may make it difficult to detect or treat potential side effects of the study drug.You need to use extra oxygen to help you breathe.You have received treatment with certain types of medications that help your immune system fight cancer.You have had an allergic reaction or are very sensitive to any of the study drugs or their ingredients.You have a buildup of fluid around your lungs that cannot be controlled with treatment.You were diagnosed with advanced-stage cancer when it had already spread extensively in your body.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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