Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 127 |
| Updated: | 2/20/2019 |
| Start Date: | January 2, 2017 |
| End Date: | December 31, 2020 |
A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer
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
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
Patients will be randomized in a 1:1 ratio to 2 treatment arms (durvalumab or SOC therapy).
The primary objective of this study is to assess the efficacy of durvalumab compared to SoC
in terms of OS (Overall Survival) in patients with NSCLC
The primary objective of this study is to assess the efficacy of durvalumab compared to SoC
in terms of OS (Overall Survival) in patients with NSCLC
Inclusion Criteria
- Aged at least 18 years
- Documented evidence of Stage IV NSCLC
- No sensitizing EGFR mutation and ALK rearrangement
- PD-L1 expression positive
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- 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]
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