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Non-small Cell Lung CancerPhase 2CHORUSNCT04905316

A Study of Canakinumab With Chemotherapy, Radiation Therapy, and Durvalumab in People With Lung Cancer

A Phase 2 study testing Canakinumab, Durvalumab and Radiation therapy in people with Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Canakinumab, Durvalumab and Radiation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
7 sitesUnited States
Study dates
21 May 2021to 6 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol- related procedures, including screening evaluations.
  • Patient age ≥ 18 at time of consent
  • Stage IIIA-C NSCLC (as per the American Joint Commission on Cancer (AJCC) 8th edition)
  • Not a candidate for surgical resection as determined by one or more of the following criteria in multidisciplinary evaluations: technically unresectable, medically inoperable, patient declines operative approach
  • Candidate for concurrent chemoradiation therapy as determined by the treating radiation and thoracic oncologist
  • Histologic confirmation of NSCLC with pathological review done at MSK
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  • ECOG Performance Status 0-1
  • Candidate for definitive thoracic radiation (defined 60Gy ± 10% in 2 Gy fractions)
  • Body weight > 30 kg
  • 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). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
  • 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 (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Must have a life expectancy of at least 6 months

Who cannot join

  • Participation in another clinical study with an investigational (non-FDA approved) product during the last 4 weeks
  • Concurrent enrollment in another clinical study for lung cancer, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
  • Previous thoracic radiation precluding definitive RT
  • Contraindication to Durvalumab
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
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  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients not on biologic therapy without active disease in the last 3 years may be included but only after consultation with the study physician
  • Patients with celiac disease controlled by diet alone
  • Prior/Current Therapies:
  • Treatment with a administered > 4 weeks earlier (intraocular bevacizumab is acceptable).monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered (i.e., ≥ Grade 1 at baseline) from adverse events due to agents
  • Patients receiving biologic drugs targeting the immune system (e.g. TNF blockers, anakinra, abatacept, tocilizumab) within 4 weeks prior to study Day 1
  • Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-Cytotoxic Tlymphocyte-associated antigen-4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Prior treatment with canakinumab
  • Current or prior use of a systemic immunosuppressive medication within 14 days before the first dose of canakinumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) ii. Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent for less than 30 days. iii. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) iv. Systemic glucocorticoid replacement for conditions such as adrenal or pituitary insufficiency.
  • Major surgical procedure (e.g. intra-cranial, intra-thoracic, intra-abdominal, or intra-pelvic) within 28 days prior to the first dose of canakinumab
  • Prior history of malignant disease, other than this NSCLC, that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include: completely resected basal cell and squamous cell skin cancers, completely resected carcinoma in situ of any type, and definitely treated Stage 0-I breast cancers on hormonal maintenance therapy or definitely treated Stage I-IIA prostate cancer.
  • History of allogenic organ transplantation.
  • Known severe concurrent illness:
  • Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Active or recurrent hepatic disorders including cirrhosis, hepatitis B and C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Active tuberculosis infection (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice)
  • Human Immunodeficiency Virus (positive HIV 1/2 antibodies).
  • Active infection requiring systemic therapy.
  • Evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Clinically significant (i.e., active) cardiovascular disease: symptomatic cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
  • Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential unless they are willing to employ a highly effective birth control from screening to 130 days after the last dose of canakinumab.
  • °Highly effective methods of contraception, defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly Note that condom use during intercourse among sexually actives males will be required. Note that some contraception methods are not considered highly effective (e.g. female cap, diaphragm, or sponge with or without spermicide; non-copper containing intrauterine device; progestogen-only oral hormonal contraceptive pills where inhibition of ovulation is not the primary mode of action [excluding Cerazette/desogestrel which is considered highly effective]; and triphasic combined oral contraceptive pills).
  • Connective tissue disorders involving the lung(s) and/or esophagus requiring active treatment or idiopathic pulmonary fibrosis
  • Known history of active primary immunodeficiency
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Receipt of live vaccination within 3 months prior to the first dose of study durg. Note that this only applies to live vaccines.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

Other trials in United States

About this study

Official title: Phase I/II Study of Canakinumab With Chemoradiation and Durvalumab for Unresected Locally-Advanced Non-Small Cell Lung Cancer (CHORUS)

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).

Being tested
Canakinumab, Durvalumab, Radiation therapy, Chemotherapy
Keywords
Locally-advanced NSCLC (stage IIIA-C), Canakinumab, Durvalumab, Chemoradiation, 21-004
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CanakinumabDrug

    Also called ACZ885

    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. Intravenous Canakinumab (ACZ885) should start no sooner than 3 weeks after the last subcutaneous Canakinumab (ACZ885) injection. 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.

  • DurvalumabDrug

    Patients will be treated with durvalumab either at a dose of 10mg per kilogram of body weight intravenously every 2 weeks or at a 1500 mg fixed dose administered every 4 weeks as consolidation therapy after completion of concurrent chemoradiation therapy, as per standard of care.

  • Radiation therapyRadiation

    Radiation therapy will be performed with external beam ionizing radiation as per standard of care in accordance with institutional practice. Intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT) will be used at the discretion of the treating radiation oncologist. Patients will be simulated in the treatment position with standard immobilization techniques for thoracic radiotherapy. The prescription dose will be 60 Gy (±10%) in 2Gy fractions to fields encompassing gross tumor and lymph nodes, as per institutional guidelines. The dose must satisfy institutional guidelines and minimize risk to adjacent organs at risk.

  • ChemotherapyDrug

    Chemotherapy will be as per standard of care in accordance with institutional practice. Patients will be treated with carboplatin or cisplatin with etoposide, paclitaxel, albumin-bound paclitaxel or pemetrexed at the discretion of the treating thoracic medical oncologist. Chemotherapy will be concurrent with radiation therapy as per standard practice, with cycle 1 day 1 of chemotherapy starting on fraction 1 of radiation ± 5 days.

Study groups in NCT04905316
Study groupRoleWhat they receive
Canakinumab with Chemoradiation and DurvalumabExperimentalTreatment 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.
Receives: Drug: Canakinumab; Drug: Durvalumab; Radiation: Radiation therapy; Drug: Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival

    Measured: 2 years

Secondary outcomes (1)

  1. Rate of grade ≥ 2 pneumonitis

    by CTCAE v. 5.0

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start21 May 2021
  3. Primary completion6 Jul 2026
  4. Study completion6 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a single-arm, prospective, phase I/II study.
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04905316
Sponsor's protocol ID
21-004
Acronym
CHORUS
Status last verified
Jul 2026
First submitted
24 May 2021
Last updated
8 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Publications

  • Shaverdian N, Offin M, Toumbacaris N, Lee J, Charalambous K, Gelblum DY, Santini FC, Shepherd AF, Gewanter R, Mueller B, Shin JY, Wu AJ, Simone CB 2nd, Rimner A, Lee NY, Ginsberg MS, Yu H, Daly B, Kris MG, Preeshagul I, Paik P, Eng J, Iqbal A, Ng K, Berger M, Shah R, Shen R, Wong P, Zhang Z, Gomez DR, Chaft JE. Canakinumab with chemoradiation and durvalumab consolidation in unresectable stage III non-small cell lung cancer: the phase I/II CHORUS trial. Nat Commun. 2026 Sep 7;17(1):10586. doi: 10.1038/s41467-026-77415-1.

    PubMed 42844242

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Canakinumab, Durvalumab and Radiation therapy in people with Non-small Cell Lung Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04905316, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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