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Immunotherapy + Local Consolidation Therapy for Lung Cancer
Study Summary
This trial is testing whether adding immunotherapy to standard local consolidation therapy can improve outcomes for patients with stage IV non-small cell lung cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My lung cancer does not have common EGFR or ALK mutations, or if it does, there's no standard treatment for them.I do not have an active autoimmune disease, except for allowed conditions like vitiligo or type I diabetes.Things like family, emotions, where you live, or other social factors may make it hard for you to follow the study plan and schedule.I haven't taken steroids for pneumonitis in the last 60 days.I haven't had cancer treatment in the last 3 weeks, except hormone therapy or contraceptives.I am receiving immunotherapy for advanced lung cancer.My lung cancer is confirmed and not small cell or carcinoid type.I am a man, sexually active with a woman capable of bearing children, and will use effective contraception.I have had cancer in the past 2 years, but it was a type that could be cured with local treatment.I am not on high-dose steroids or strong immune system medications.I am aware of the liver risks with my cancer treatment and will be cautious with certain medications.Your liver function test results should be within a certain range before you can join the study.My brain metastases are treated, I'm neurologically stable, and not on high steroids.I may have had radiation for cancer spread but still have at least one untreated spot.I have signed and understand the consent form according to the study's rules.I've had one round of treatment for my cancer after it spread, including drugs to stop new blood vessels from forming.My kidney function tests are within the normal range.I am using or willing to use birth control as required if I can have children.My cancer is stage IV and can be measured for changes.Your hemoglobin level is higher than 9.0 grams per deciliter within the 14 days before starting the study.Your blood platelet count is at least 100,000 per microliter.Your white blood cell count is lower than 2000 cells per microliter.You have had a strong allergic reaction to any monoclonal antibody in the past.Your neutrophil count is at least 1500 per microliter within 14 days before starting the study.I do not have hepatitis B or C.I have taken a pregnancy test within the last 48 hours and it was negative.You are required by law to stay in a hospital for treatment of a mental illness or infectious disease.I am fully active or restricted in physically strenuous activity but can do light work.Your bilirubin level needs to be within a certain range, but if you have Gilbert syndrome, it can be a little higher.
- Group 1: Arm B (ipilimumab, nivolumab, LCT)
- Group 2: Arm A (ipilimumab, nivolumab)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What disease is Local Consolidation Therapy most effective in treating?
"Local Consolidation Therapy is a type of treatment that is often used after anti-angiogenic therapy. It can also be effective in treating malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Are we still able to enroll patients in this research project?
"This trial is still enrolling patients, according to the information available on clinicaltrials.gov. The listing for this study was first created on December 29th, 2017 and was most recently edited on November 8th, 2020."
How many places are coordinating this clinical trial?
"There are six enrolling patients for this clinical trial. Three of those locations are MD Anderson in Sugar Land, MD Anderson League City and M D Anderson Cancer Center in Conroe. The other 6 sites are _____."
What are the most recent findings from research on Local Consolidation Therapy?
"At the moment, there are 796 active clinical trials researching Local Consolidation Therapy. 86 of those trials have progressed to Phase 3. The majority of these Local Consolidation Therapy trials originate in Pittsburgh, Pennsylvania; however, 43289 different locations across the world are trialing this treatment."
What are the risks associated with Local Consolidation Therapy?
"Local Consolidation Therapy has some efficacy data supporting it and multiple rounds of safety testing, so it received a score of 3."
How many people fit the screening criteria for this experiment?
"That is correct, the most recent update on clinicaltrials.gov confirms that 360 patients are needed for this study that was originally posted on December 29th, 2017. The study is looking for volunteers at six different locations."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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