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