Study of Durvalumab Following Radiation Therapy in Patients With Stage 3 Unresectable NSCLC Ineligible for Chemotherapy (DUART)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2023
  • participants needed
    150
  • sponsor
    AstraZeneca
Updated on 23 July 2022
durvalumab
cancer chemotherapy

Summary

This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who are deemed to be ineligible for chemotherapy per Investigator assessment. Patients will be enrolled into 2 cohorts according to radiotherapy pretreatment dose (Cohort A: standard radiation therapy [60 gray (Gy) ± 10% or hypofractionated bioequivalent dose (BED)]; Cohort B: palliative radiation therapy [40 to < 54 Gy or hypofractionated BED]).

Description

This is a Phase II open-label, single-arm, multicenter, international study to evaluate the clinical activity of durvalumab in patients with Stage III unresectable NSCLC who have an Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2 and who were treated with radiotherapy but are ineligible for chemotherapy. Patients will be enrolled into 2 cohorts according to the dose of radiotherapy received prior to study entry (Cohort A: Standard Radiotherapy [60 Gy ± 10% or hypofractionated BED]; Cohort B: Palliative Radiotherapy [40 to < 54 Gy or hypofractionated BED]). Patients must not have progressed following radiation therapy, and radiation therapy must be completed within 6 weeks (42 days) prior to first study drug administration. The last dose of radiation therapy is defined as the day of the last radiation treatment session. All patients will receive 1500 mg durvalumab via IV infusion every 4 weeks (q4w) for up to a maximum of 12 months (up to 13 doses/cycles)

Details
Condition Non-small Cell Lung Cancer
Treatment durvalumab
Clinical Study IdentifierNCT04249362
SponsorAstraZeneca
Last Modified on23 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab
Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
Participation in another clinical study with an IP administered in the last 4 weeks
Concurrent enrollment in another clinical study, unless it is an observational (noninterventional) clinical study or during the follow-up period of an interventional study
Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
Patients who refuse chemotherapy by their own decision
Involvement in the planning and/or conduct of the study
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control
Judgment by the Investigator that the patient should not participate in the study
Genetics research study (optional)
Exclusion criteria for participation in the optional genetics research component of the
study include: a) Previous allogeneic bone marrow transplant b)Nonleukocyte-depleted whole
blood transfusion within 120 days of genetic sample collection

Exclusion Criteria

Patients with locally-advanced NSCLC whose disease has progressed following radiation therapy
Mixed small cell lung cancer and NSCLC histology
History of allogeneic organ transplantation
Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
Uncontrolled intercurrent illness (e.g., ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris)
History of another primary malignancy except for (a) malignancy treated with curative intent and with no known active disease ≥ 5 years before the first study drug administration, (b) adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease, and c) treated carcinoma in situ without evidence of disease
History of leptomeningeal carcinomatosis
History of active primary immunodeficiency
Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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