Combination Therapy for Lung Cancer

(CHORUS Trial)

Recruiting at7 trial locations

Overseen by Narek Shaverdian, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The researchers are doing this study to find out whether canakinumab in combination with chemoradiation and durvalumab is an effective and safe treatment for people with locally advanced non-small cell lung cancer (NSCLC).

Research Team

Narek Shaverdian, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

My lung cancer was confirmed by a pathology review at MSK.

I am 18 years old or older.

My blood counts and liver/kidney functions are within the required ranges.

Exclusion Criteria

I have not received a live vaccine in the last 3 months.

I have received an organ transplant from another person.

I haven't had certain immune-targeting drugs or antibodies in the last 4 weeks.

Treatment Details

Interventions

• Canakinumab (Monoclonal Antibodies)
• Chemotherapy (Anti-cancer agent)
• Durvalumab (Checkpoint Inhibitor)
• Radiation therapy (Radiation)

Trial Overview 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.

Participant Groups

Group I: Canakinumab with Chemoradiation and Durvalumab Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Novartis Pharmaceuticals

Industry Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

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