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

NCT04905316 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-06-17

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Canakinumab

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.

DRUG

Durvalumab

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

Radiation therapy

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.

DRUG

Chemotherapy

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.

Sponsors & Collaborators

Principal Investigators

  • Narek Shaverdian, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04905316 on ClinicalTrials.gov