A Study of Canakinumab With Chemotherapy, Radiation Therapy, and Durvalumab in People With Lung C… (NCT04905316) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Canakinumab With Chemotherapy, Radiation Therapy, and Durvalumab in People With Lung Cancer
United States41 participantsStarted 2021-05-21
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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 hemolysi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2, which means it's still building evidence — can you help me understand how much is currently known about the safety and effectiveness of combining canakinumab with chemotherapy, radiation, and durvalumab specifically for non-small cell lung cancer?
2The trial is no longer enrolling new patients — does that mean I can't participate, or are there related studies or similar combination approaches I should be looking into instead?
3Since this study is measuring progression-free survival as its main goal, what does that mean in practical terms, and how might the results compare to what I could expect from a standard treatment approach for my stage of non-small cell lung cancer?
4Canakinumab is an anti-inflammatory drug not typically used in lung cancer treatment — what is the thinking behind adding it to chemotherapy, radiation, and an immunotherapy like durvalumab, and are there any particular risks I should know about from combining all four?
5Given that this trial combines multiple treatments at once, how demanding would a regimen like this typically be on a patient's daily life, and is that something worth discussing with my care team when weighing my options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.