Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Clinical summary
Summary
This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type and with PD-L1-high expression
Conditions
This trial is treating people with Non-Small Cell (NSC) Lung Cancer (EGFR and ALK)
Eligibility
Inclusion
- Aged at least 18 years
- Documented evidence of Stage IV NSCLC
- No sensitizing EGFR mutation and ALK rearrangement
- PD-L1 high expression
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion
- Prior chemotherapy or any other systemic therapy for advanced NSCLC
- Prior exposure to immune-mediated therapy, including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
- Brain metastases or spinal cord compression unless the patient is stable and off steroids for at least 14 days prior to start of study treatment
- Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
- Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or Crohn's disease]
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
AstraZeneca
Scientific Title
A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab Versus Standard of Care Platinum-Based Chemotherapy as First Line Treatment in Patients with PD-L1-High Expression Advanced Non-Small-Cell Lung Cancer (NSCLC)
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