Global Study on Durvalumab with Oleclumab or Monalizumab After Chemoradiation for Stage III Unresectable Non-Small Cell Lung Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT05221840
This international clinical trial is testing the safety and effectiveness of combining durvalumab with either oleclumab or monalizumab in patients with Stage III non-small cell lung cancer (NSCLC) that cannot be removed by surgery and has not worsened after initial treatment with chemotherapy and radiation.
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Program Overview
This study is exploring whether adding oleclumab or monalizumab to durvalumab can improve treatment outcomes for adults with locally advanced, Stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed. Participants must have already received chemotherapy and radiation therapy and shown no progression of their cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of non-small cell lung cancer (NSCLC) that is locally advanced and cannot be surgically removed.
- Have completed chemotherapy and radiation therapy for Stage III NSCLC without the cancer getting worse.
- Provide a tumor tissue sample taken before starting chemoradiation therapy.
- Have specific tumor markers, including PD-L1, EGFR, and ALK, as determined by lab tests.
- Have received at least two cycles of platinum-based chemotherapy along with radiation therapy.
- Have received a specific dose of radiation (between 54 Gy and 66 Gy) using preferred techniques.
- 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 cancer, unless it was treated successfully and has been inactive for at least 5 years, or is a non-threatening type like certain skin cancers.
- Have a mix of small cell and non-small cell lung cancer.
- Have received a different sequence of chemoradiation therapy than specified.
- Have cancer that worsened during initial chemoradiation therapy.
- Have unresolved side effects from previous treatment, except for hair loss.
- Have had significant lung inflammation or other lung conditions, such as pneumonitis or fibrosis, recently or in the past.
- Have active or past autoimmune or inflammatory disorders, with some exceptions.
- Have used immunosuppressive medications within 14 days before starting durvalumab.
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