Combination Therapy for Lung Cancer
(CHORUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination for individuals with non-small cell lung cancer (NSCLC) that cannot be surgically removed. Researchers aim to determine if adding canakinumab (Ilaris, an anti-inflammatory drug) to standard treatments like chemotherapy, radiation, and durvalumab enhances effectiveness and safety. Individuals with this specific type of lung cancer who are not candidates for surgery might be suitable for the trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot use systemic immunosuppressive medications within 14 days before starting the trial, with some exceptions like certain steroids. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that canakinumab, when combined with chemoradiation and durvalumab, is generally well-tolerated. Previous studies have examined canakinumab's role in treating non-small cell lung cancer and other conditions, without identifying major safety concerns. Although canakinumab did not improve disease-free survival in some lung cancer studies, significant serious side effects were not reported.
Durvalumab is already approved for certain lung cancers, indicating its safety is well understood. In combination therapies like this one, the primary goal is to determine if these treatments work better together without causing serious side effects. Since this trial is in Phase 2, the treatment has passed initial safety tests in earlier studies. However, as with any trial, monitoring for new or unexpected side effects remains crucial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination therapy for lung cancer because it includes canakinumab, a unique anti-inflammatory drug that targets the interleukin-1β (IL-1β) pathway, which is different from typical treatments. Standard lung cancer treatments often involve chemotherapy, radiation, and immunotherapy like durvalumab, but canakinumab adds a novel mechanism by potentially reducing inflammation that can aid tumor growth. Additionally, this treatment regime integrates both subcutaneous and intravenous administration of canakinumab alongside established therapies, which could enhance effectiveness and improve outcomes compared to standard care alone. This innovative approach has the potential to offer better control over tumor progression and improve survival rates for patients.
What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?
In this trial, participants will receive a combination of canakinumab with chemoradiation and durvalumab to treat non-small cell lung cancer (NSCLC). Research has shown that canakinumab, when combined with chemoradiation and durvalumab, may aid in treating NSCLC. Canakinumab reduces lung cancer risk and death by targeting interleukin-1 beta, a protein involved in inflammation. However, the CANOPY-A study did not find that canakinumab improved disease-free survival when used after surgery in NSCLC patients. The combination with durvalumab, a type of immunotherapy, aims to strengthen the body's immune response against cancer cells. While early results are encouraging, further research is needed to confirm the effectiveness of this combination therapy for NSCLC.23456
Who Is on the Research Team?
Narek Shaverdian, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with Stage IIIA-C non-small cell lung cancer who can't have surgery. They must be able to follow the study plan, have good organ function, and a life expectancy of at least 6 months. Pregnant or breastfeeding individuals are excluded, as well as those with certain autoimmune diseases, recent major surgeries, other cancers within 3 years, or severe illnesses.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiation
Participants receive canakinumab administered as a subcutaneous injection every 3 weeks for 3 cycles concurrent with standard of care concurrent chemoradiation
Durvalumab Treatment
Participants receive canakinumab administered intravenously every 4 weeks for up to 12 total infusions concurrent with standard of care durvalumab
Follow-up
Participants are monitored for safety and effectiveness after treatment, including survival outcomes by chart review
What Are the Treatments Tested in This Trial?
Interventions
- Canakinumab
- Chemotherapy
- Durvalumab
- Radiation therapy
Canakinumab is already approved in European Union, United States for the following indications:
- Cryopyrin-Associated Periodic Syndromes (CAPS)
- Familial Cold Autoinflammatory Syndrome (FCAS)
- Muckle-Wells Syndrome (MWS)
- Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS)
- Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
- Familial Mediterranean Fever (FMF)
- Systemic Juvenile Idiopathic Arthritis (SJIA)
- Adult-Onset Still's Disease (AOSD)
- Cryopyrin-Associated Periodic Syndromes (CAPS)
- Familial Cold Autoinflammatory Syndrome (FCAS)
- Muckle-Wells Syndrome (MWS)
- Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS)
- Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
- Familial Mediterranean Fever (FMF)
- Systemic Juvenile Idiopathic Arthritis (SJIA)
- Adult-Onset Still's Disease (AOSD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Novartis Pharmaceuticals
Industry Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD