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

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

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.

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