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Monoclonal Antibodies

Combination Therapy for Lung Cancer (CHORUS Trial)

Phase 2
Waitlist Available
Led By Narek Shaverdian, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologic confirmation of NSCLC with pathological review done at MSK
Adequate normal organ and marrow function as defined below: Hemoglobin ≥9.0 g/dL, Absolute neutrophil count (ANC) 1.5 x (> 1500 per mm3), Platelet count ≥100 x 10^9/L (>100,000 per mm3), Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN) (exceptions for patients with confirmed Gilbert's syndrome), AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal, Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

CHORUS Trial Summary

This trial is testing a new combination treatment for people with NSCLC.

Who is the study for?
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.Check my eligibility
What is being tested?
The study tests if canakinumab combined with chemoradiation and durvalumab is effective for treating locally advanced non-small cell lung cancer. Participants will receive this combination therapy to see how well it works compared to current treatments.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may affect organs, infusion-related reactions from the drugs being administered into the bloodstream, fatigue from treatment stress on the body's energy levels, and increased risk of infections due to weakened immunity.

CHORUS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer was confirmed by a pathology review at MSK.
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My blood counts and liver/kidney functions are within the required ranges.
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I am 18 years old or older.
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I cannot have surgery for my condition as advised by doctors.
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I am eligible for a specific chest radiation therapy.
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My doctors agree I should have chemotherapy and radiation at the same time.
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I can sign and will follow the study's rules as explained in the consent form.
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My lung cancer is at stage IIIA-C.
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My body weight is over 30 kg.
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I am willing and able to follow the study's treatment plan and attend all visits.
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I am fully active or can carry out light work.
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I am post-menopausal or have a negative pregnancy test if pre-menopausal.

CHORUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
progression-free survival
Secondary outcome measures
Rate of grade ≥ 2 pneumonitis

CHORUS Trial Design

1Treatment groups
Experimental Treatment
Group I: Canakinumab with Chemoradiation and DurvalumabExperimental Treatment4 Interventions
Treatment will consist of canakinumab (ACZ885) administered as a subcutaneous injection every 3 weeks for 3 cycles concurrent with standard of care concurrent chemoradiation, followed by canakinumab administered intravenously every 4 weeks for up to 12 total infusions concurrent with standard of care durvalumab. Canakinumab (ACZ885) will be dosed at 200mg via subcutaneous injection every 3 weeks x 3 injections that will start with concurrent chemoradiation, followed by 200mg via intravenous infusion every 4 weeks x 12 infusions that will start with the initiation of durvalumab. Canakinumab (ACZ885) will be concurrent with thoracic chemoradiation and durvalumab therapy for up to 15 cycles, or until disease progression or unacceptable toxicity, whichever occurs first. Patients that come off treatment for progression, or have progression after completion of all protocol-related therapy, can be followed for survival outcomes by chart review based on standard of care evaluations.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
2011
Completed Phase 3
~3090
Radiation therapy
2013
Completed Phase 3
~2850
Chemotherapy
2003
Completed Phase 4
~3050
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,579 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,309 Total Patients Enrolled
Narek Shaverdian, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
221 Total Patients Enrolled

Media Library

Canakinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04905316 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Canakinumab with Chemoradiation and Durvalumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Canakinumab Highlights & Side Effects. Trial Name: NCT04905316 — Phase 2
Canakinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04905316 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research inquiry being conducted in multiple Canadian locations?

"This research is currently being conducted at 7 distinct loci, which encompasses the cities of Harrison, Middletown and Montvale in addition to four other urban centres. It may be prudent for prospective participants to choose a location that is nearby in order to reduce travel burdens."

Answered by AI

Are there any other research projects that have employed Chemotherapy?

"The origins of chemotherapy can be traced back to 2010 with the City of Hope's pioneering work. Since then, there have been 291 clinical trials completed and an additional 348 are underway; many in Harrison, New jersey."

Answered by AI

What maladies can be addressed with Chemotherapy?

"Unresectable Stage III Non-Small cell lung cancer is typically managed with chemotherapy, a therapy that has been found to effectively tackle conditions like Juvenile Idiopathic Arthritis and Neonatal-Onset Multisystem Inflammatory Disease (NOMID)."

Answered by AI

What potential hazards should be considered when using Chemotherapy?

"Although there is a dearth of evidence that chemotherapy works, data showing its safety has been collected. Therefore, it received an overall rating of 2."

Answered by AI

How many participants are currently partaking in this trial?

"Affirmative. According to the information present on clinicaltrials.gov, this trial is currently recruiting participants after it was unveiled on May 21st 2021 and updated most recently on August 15th 2022. Specifically, 32 individuals will be accepted across seven different sites."

Answered by AI

Is enrollment for this experiment open at the moment?

"Yes, the clinicaltrial.gov page shows that this trial is actively enrolling patients. It was published on May 21st 2021 and the latest update occured on August 15th 2022. 32 individuals are sought out from 7 different medical centres for participation in this study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Canakinumab With Chemotherapy, Radiation Therapy, and Durvalumab in People With Lung Cancer
2021. "A Study of Canakinumab With Chemotherapy, Radiation Therapy, and Durvalumab in People With Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04905316.
~0 spots leftby May 2024
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