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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04905316
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab — DRUG
    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.
  • Durvalumab — DRUG
    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 therapy — RADIATION
    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.
  • Chemotherapy — DRUG
    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 Details

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).

Key Dates

Start date
May 21, 2021
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
41 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab with Chemoradiation and Durvalumab
    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.

Primary Outcome Measure

progression-free survival [ Time Frame: 2 years ]

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

Related Studies