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Checkpoint Inhibitor
Immunotherapy + Radiation for Lung Cancer
Phase 1
Waitlist Available
Led By Anne S Tsao
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement are eligible
No prior history of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computerized tomography (CT) scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing the side effects of a new immunotherapy treatment for lung cancer, and whether it is more effective than standard chemotherapy.
Who is the study for?
This trial is for adults with stage II-III non-small cell lung cancer that can't be removed by surgery or patients who refuse surgery. They must have a good performance status, meaning they're fairly active and able to care for themselves. People with certain stable autoimmune conditions or controlled diabetes may join. However, those with recent other cancers, severe allergies to similar drugs, untreated infections like TB or hepatitis, HIV, or on immunosuppressive therapy cannot participate.Check my eligibility
What is being tested?
The trial tests the combination of two immune system-boosting drugs (Ipilimumab and Nivolumab) with radiation therapy against lung cancer. The goal is to see if this combo helps the body's own defense system fight cancer better and makes tumor cells more sensitive to radiation compared to standard chemotherapy plus radiation.See study design
What are the potential side effects?
Possible side effects include typical reactions from immune therapies such as fatigue, skin issues like rash or itching, digestive problems like diarrhea or colitis (inflammation of the inner lining of the colon), potential hormonal gland problems (like thyroid dysfunction), and flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has an EGFR mutation or ALK rearrangement.
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I have never had lung fibrosis, pneumonitis, or organizing pneumonia.
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My lung cancer is at stage II or III and cannot be removed by surgery.
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I have never had an autoimmune disease.
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I haven't received any treatment for my current stage II or III lung cancer.
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My lung cancer diagnosis was confirmed through lab tests.
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I can take care of myself but might not be able to do heavy physical work.
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My kidney function is good, with a GFR of 50 mL/min/1.73 m^2 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Anti-tumor activity
Duration of response
Overall response rate
+4 moreOther outcome measures
Microbiome evaluation
Tumor tissue/blood biomarkers
Side effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
Alopecia
36%
Anaemia
32%
Nausea
31%
Decreased appetite
31%
Diarrhoea
30%
Fatigue
25%
Constipation
23%
Neutropenia
20%
Dyspnoea
19%
Vomiting
19%
Pyrexia
18%
Rash
17%
Asthenia
17%
Cough
16%
Pruritus
16%
Thrombocytopenia
16%
Arthralgia
15%
Peripheral sensory neuropathy
14%
Myalgia
13%
Insomnia
13%
Neuropathy peripheral
11%
Hypokalaemia
10%
Platelet count decreased
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung neoplasm malignant
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nivolumab, ipilimumab, radiation therapy)Experimental Treatment3 Interventions
CONCURRENT THERAPY: Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 30 minutes on day 1. Treatment with nivolumab repeats every 21 days for up to 8 cycles, and treatment with ipilimumab repeats every 42 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 1 day of starting nivolumab and ipilimumab, patients also undergo radiation therapy 5 days a week (Monday-Friday) over 6-7 weeks in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Ipilimumab
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,646 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,781 Total Patients Enrolled
Anne S TsaoPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
339 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had strong allergic reactions to certain types of medications made from antibodies or fusion proteins.My cancer has an EGFR mutation or ALK rearrangement.I am HIV positive.You have enough white blood cells called neutrophils.I have never had lung fibrosis, pneumonitis, or organizing pneumonia.Your creatinine levels are within a certain range set by the hospital.You have had a bone marrow or solid organ transplant from someone else in the past.I haven't had any cancer besides this one in the last 3 years.I have active, untreated tuberculosis.My lung cancer is at stage II or III and cannot be removed by surgery.I have never had an autoimmune disease.You have a low level of white blood cells.You have had allergic reactions to drugs similar to nivolumab.I haven't received any treatment for my current stage II or III lung cancer.My lung cancer diagnosis was confirmed through lab tests.Your AST and ALT levels in your blood should not be more than three times the normal limit set by the hospital.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.You can have eczema, psoriasis, lichen simplex chronicus, or vitiligo with skin symptoms only in certain situations.I have type 1 diabetes that is well-managed with a stable insulin routine.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have autoimmune hypothyroidism but am on a stable thyroid medication.I can take care of myself but might not be able to do heavy physical work.I have hepatitis that hasn't been treated.You are currently taking any experimental medications.My kidney function is good, with a GFR of 50 mL/min/1.73 m^2 or higher.I have had treatment for my advanced lung cancer that has not spread far.You must have a platelet count of at least 75,000 per microliter.I am currently on medication that weakens my immune system.Your total bilirubin level is not higher than 1.5 times the normal limit at the medical facility.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab, ipilimumab, radiation therapy)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
What therapeutic applications are associated with Ipilimumab?
"Ipilimumab is often prescribed as an anti-angiogenic therapy; this drug also offers benefits for patients with certain malignant neoplasms, melanomas which can't be surgically removed, and squamous cell carcinoma."
Answered by AI
What is the upper limit for participants in this research endeavor?
"Indeed, the information on clinicaltrials.gov indicates that this trial is currently enrolling patients. It was initially posted on September 13th 2019 and its data has been refreshed as recently as September 30th 2022. The study requires 20 participants from one medical centre."
Answered by AI
Has Ipilimumab attained regulatory approval from the FDA?
"Our organization has gauged the safety of Ipilimumab to be a 1, as this trial is currently in Phase 1. This indicates that there is limited evidence supporting both efficacy and security."
Answered by AI
Are new participants currently being added to this experiment?
"The official report on clinicaltrials.gov reveals that this research project is recruiting participants. The trial was first initiated on September 13th 2019 and the data set was recently refreshed on September 30th 2022."
Answered by AI
Have any other research projects explored the efficacy of Ipilimumab?
"Presently, 764 Ipilimumab trials are in progress worldwide. Of these, 86 have entered the third phase with most being situated near Pittsburgh, Pennsylvania. Specifically, 42752 medical facilities are conducting research on this specific medication."
Answered by AI
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