Study on Durvalumab and Tremelimumab with Chemotherapy or Chemotherapy Alone for Lung Cancer Patients (POSEIDON)
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03164616
This clinical trial is testing different combinations of treatments for patients with advanced non-small cell lung cancer (NSCLC) to see which is most effective. The study compares the use of durvalumab and tremelimumab with chemotherapy, durvalumab with chemotherapy, and chemotherapy alone.
Patient Parameters
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Program Overview
The purpose of this study is to find out how well different treatment combinations work for patients with advanced non-small cell lung cancer (NSCLC) that does not have certain genetic changes (EGFR mutations and ALK fusions). The study will compare three groups: one receiving durvalumab and tremelimumab with chemotherapy, another receiving durvalumab with chemotherapy, and the last receiving only chemotherapy. Patients will have regular scans to check the cancer's response to treatment, and their health will be monitored throughout the study.
Description
This study involves adult patients with advanced non-small cell lung cancer (NSCLC) that has spread to other parts of the body. To participate, patients must have tumors without specific genetic changes known as EGFR mutations and ALK fusions. Participants will be randomly assigned to one of three treatment groups: one group will receive a combination of durvalumab and tremelimumab with standard chemotherapy, another group will receive durvalumab with standard chemotherapy, and the third group will receive only standard chemotherapy. The effectiveness of these treatments will be assessed through regular scans to monitor the cancer's progression. Patients will continue to be monitored for their overall health and survival throughout the study. An independent committee of experts will review the safety and effectiveness of the treatments.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have advanced non-small cell lung cancer (NSCLC) confirmed by lab tests.
- Tumors must not have specific genetic changes (EGFR mutations and ALK fusions).
- Must not have received any previous chemotherapy or systemic therapy for advanced NSCLC.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must not have had previous immune-based cancer treatments, except for cancer vaccines.
Exclusion Criteria
- Have a mix of small-cell lung cancer and NSCLC, or a sarcomatoid variant.
- Have active or previously diagnosed autoimmune or inflammatory disorders.
- Have brain metastases or spinal cord compression unless stable and not requiring steroids.
- Have active infections such as tuberculosis, hepatitis B, hepatitis C, or HIV.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85054 | Phoenix | Arizona |
| Research Site | 93309 | Bakersfield | California |
| Research Site | 90404 | Santa Monica | California |
| Research Site | 33901 | Fort Myers | Florida |
| Research Site | 32224 | Jacksonville | Florida |
| Research Site | 33705 | St. Petersburg | Florida |
| Research Site | 33401 | West Palm Beach | Florida |
| Research Site | 40202 | Louisville | Kentucky |
| Research Site | 64132 | Kansas City | Missouri |
| Research Site | 44710 | Canton | Ohio |
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