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CC-90011 + Nivolumab for Advanced Lung Cancer
Study Summary
This trial is testing a new drug combination to see if it is more effective than standard of care for lung cancer patients who have progressed after 1 or 2 lines of therapies. The primary objective is to evaluate the overall response rate in three cohorts of patients.
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Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- This is for people with a type of lung cancer called small cell lung cancer who have not yet received immune checkpoint inhibitors.This criterion is for patients with small cell lung cancer (SCLC) who have previously received immunotherapy and their disease has progressed.You have any of the following heart-related conditions:Your blood pressure is very high and not under control.You have received immunotherapy as one of your previous treatments.You have received at least one treatment that included a specific type of chemotherapy called platinum-based doublet.You have not responded well to the most recent treatment you received.You have had serious allergic reactions to other types of drugs similar to monoclonal antibodies.You have ulcers in your stomach or intestines that are causing symptoms or are not under control.You have experienced a heart attack or unstable chest pain within the past 6 months.You had a stroke or mini-stroke (also known as TIA) within the past 6 months.You have a history of conditions that increase the risk of a certain type of irregular heart rhythm called Torsades de pointes (TdP). This includes things like heart failure, low potassium levels, or a family history of Long QT Syndrome.You have a history of lung disease called interstitial lung disease.This criterion applies to individuals with advanced squamous non-small cell lung cancer who have experienced disease progression while receiving immunotherapy treatment.You have already received treatments for LSD1 in the past.You have brain tumors that are causing symptoms and have not been treated or are unstable.You have ongoing severe diarrhea caused by a condition that affects how your body absorbs nutrients, like celiac disease or inflammatory bowel disease. Or, you have any other major gastrointestinal disorder that could affect how your body absorbs the study medications.
- Group 1: Cohort B: SCLC in ICI progressor subjects
- Group 2: Cohort C: sqNSCLC in ICI progressor subjects
- Group 3: Arm A: SCLC in ICI naïve subjects
- 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
Are there any additional investigations which have employed CC-90011?
"CC-90011 was first studied 8 years ago at Local Institution. After 253 trials, the drug is being actively tested in 718 separate studies, primarily centered around Pittsburgh, Pennsylvania."
To what end is the drug CC-90011 typically utilized?
"CC-90011 is the standard treatment for malignant neoplasms and can also be employed to tackle other medical issues such as metastatic esophageal adenocarcinoma, squamous cell carcinoma, and unresectable melanoma."
Is registration for this experiment currently available?
"This research endeavour is no longer enrolling participants. The study was initially published on July 14th 2020, and the information was last updated November 8th 2022. For those interested in alternative studies related to cancer, there are 2374 active trials and 718 specifically involving CC-90011 currently searching for volunteers."
How many participants have joined this experiment up to now?
"Unfortunately, recruitment for this trial has concluded. It was initially posted on July 14th 2020 and last updated November 8th 2022. For those looking for other clinical trials involving cancer, there are 2374 studies recruiting patients; alternatively, 718 studies are in need of volunteers to test the efficacy of CC-90011."
Is this experiment being administered in multiple healthcare facilities across the state?
"19 sites are presently participating in this clinical trial. These include Local Institution - 109 of Pittsburgh, Local Institution - 107 based in Fort Sam Houston, and Local Institution - 111 located in Fairfax among other centres."
What potential risks might be associated with CC-90011 treatment?
"Although there is evidence that CC-90011 is safe, it has yet to be established as effective, so our team at Power assigned this medication a score of 2."
Is this an inaugural attempt at a trial of this kind?
"Currently, 2354 cities and 49 countries are hosting 718 active trials involving CC-90011. The inaugural research experiment took place in 2012 courtesy of Ono Pharmaceutical Co. Ltd., which enrolled 659 participants to complete the initial two phases of drug approval testing. Since its inception eight years ago, an additional 253 studies have been conducted worldwide."
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