Global Study on Durvalumab and Domvanalimab After Chemoradiation for Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT05211895

This international clinical trial is testing the effectiveness and safety of combining durvalumab and domvanalimab compared to durvalumab with a placebo in adults with Stage III NSCLC that cannot be removed by surgery and has not worsened after chemoradiation treatment.

Patient Parameters

Program Overview

This study is exploring whether a combination of two drugs, durvalumab and domvanalimab, can help treat adults with Stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed. The trial is for patients whose cancer has not progressed after receiving a specific type of chemotherapy and radiation treatment. Participants will be randomly assigned to receive either the drug combination or durvalumab with a placebo, and the study will assess the safety and effectiveness of these treatments.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) and have received chemoradiation for locally advanced, unresectable Stage III disease.
  • Provide a tumor tissue sample taken before chemoradiation treatment.
  • Tumor must have a PD-L1 status of 1% or higher.
  • Must not have specific genetic mutations (EGFR and ALK wild-type).
  • Cancer must not have worsened after receiving platinum-based chemoradiation.
  • Must have completed at least 2 cycles of platinum-based chemotherapy with radiation.
  • Must have received a specific dose of radiation (54 Gy to 66 Gy) during treatment.
  • Have a WHO performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ and bone marrow function.

Exclusion Criteria

  • Have a history of another primary cancer, except for certain types that have been treated and are not active.
  • Have a mix of small cell and non-small cell lung cancer.
  • Received a different sequence of chemoradiation therapy for Stage III NSCLC.
  • Cancer has worsened during platinum-based chemoradiation.
  • Have unresolved side effects from previous treatment, except for hair loss.
  • Have had significant lung inflammation (pneumonitis) from previous treatment.
  • Have certain lung conditions like pulmonary fibrosis or active pneumonia.
  • Have active or past autoimmune or inflammatory disorders, with some exceptions.
  • Have an active Epstein-Barr virus (EBV) infection.
  • Have used immunosuppressive medication within 14 days before starting durvalumab.

Locations

FACILITYZIPCITYSTATE
Research Site85224ChandlerArizona
Research Site85054PhoenixArizona
Research Site92708Fountain ValleyCalifornia
Research Site95403Santa RosaCalifornia
Research Site20016WashingtonDistrict of Columbia
Research Site32224JacksonvilleFlorida
Research Site32804OrlandoFlorida
Research Site32086Saint AugustineFlorida
Research Site31217MaconGeorgia
Research Site60126ElmhurstIllinois

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