Study on Durvalumab or Chemotherapy for Advanced Non-Small Cell Lung Cancer (PEARL)
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03003962
This clinical trial is comparing the effectiveness and safety of the drug durvalumab against standard chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have high levels of a protein called PD-L1 and do not have certain genetic mutations.
Patient Parameters
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Program Overview
The study aims to find out if durvalumab, an immunotherapy drug, is more effective than the usual chemotherapy treatment for patients with advanced non-small cell lung cancer (NSCLC). It focuses on patients whose cancer does not have specific genetic changes (EGFR and ALK) and who have high PD-L1 expression. Participants will be randomly assigned to receive either durvalumab or standard chemotherapy to see which treatment helps them live longer.
Description
In this study, patients with stage IV non-small cell lung cancer (NSCLC) will be randomly divided into two groups. One group will receive the immunotherapy drug durvalumab, while the other group will receive the standard chemotherapy treatment. The main goals are to compare how long patients live with each treatment and to see if durvalumab is more effective for those at lower risk of early death. The study will help determine if durvalumab can be a better first-line treatment option for patients with advanced NSCLC.
Eligibility Criteria
Exclusion Criteria
- Have received chemotherapy or other treatments for advanced NSCLC before.
- Have been treated with immune-based therapies like CTLA-4, PD-1, PD-L1, or PD-L2 antibodies, except for cancer vaccines.
- Have brain metastases or spinal cord compression unless stable and off steroids for at least 14 days before starting the study.
- Have a mix of small-cell lung cancer and NSCLC, or a sarcomatoid variant.
- Have active or previously documented autoimmune or inflammatory disorders, such as colitis or Crohn's disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 92801 | Anaheim | California |
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