Study on Durvalumab with Olaparib or Alone After Initial Treatment in Lung Cancer Patients (ORION)
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03775486
This clinical trial is testing whether combining Durvalumab with Olaparib is more effective than using Durvalumab alone as a follow-up treatment for patients with advanced non-small cell lung cancer (NSCLC) who have already received initial chemotherapy and Durvalumab.
Patient Parameters
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Program Overview
The study aims to find out if adding Olaparib to Durvalumab can better maintain cancer control in patients with Stage IV non-small cell lung cancer (NSCLC) who have already been treated with Durvalumab and chemotherapy. This trial is for patients whose cancer does not have specific genetic changes (EGFR mutations or ALK fusions) and who have not seen their cancer progress after initial treatment.
Description
This study involves patients with advanced non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation. To participate, patients must have tumors without certain genetic changes (EGFR mutations or ALK fusions). Initially, patients will receive Durvalumab along with a choice of chemotherapy drugs based on their type of NSCLC. After completing four cycles of this initial treatment, patients whose cancer has not progressed will be randomly assigned to receive either Durvalumab with a placebo or Durvalumab with Olaparib as ongoing maintenance therapy. This maintenance treatment will continue until the cancer progresses, side effects become unacceptable, or the patient chooses to stop. Regular scans will be conducted to monitor the cancer's status, and all patients will be followed for survival throughout the study.
Eligibility Criteria
Inclusion Criteria
- Have Stage IV non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
- Tumors must not have specific genetic changes (EGFR mutations or ALK fusions).
- Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have not received prior chemotherapy or systemic therapy for Stage IV NSCLC.
- Have good organ and bone marrow function without recent blood transfusions.
- Have at least one measurable tumor that has not been treated with radiation.
Key criteria for continuing to maintenance treatment:
- Show stable disease or improvement after initial chemotherapy.
- Have adequate kidney function.
- Be able to swallow pills.
- Provide a tumor sample for testing, either newly collected or from the past three years.
Exclusion Criteria
- Have a type of lung cancer that includes small-cell or sarcomatoid features.
- Have previously received chemotherapy, PARP inhibitors, or immune therapies for cancer.
- Have active or past autoimmune or inflammatory diseases.
- Be receiving other cancer treatments or immunosuppressive medications recently.
- Have untreated brain metastases or cancer in the brain lining.
- Have an active infection.
Exclusion criteria for maintenance treatment:
- Unable to complete initial chemotherapy cycles or had to stop Durvalumab during initial treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 34135 | Bonita Springs | Florida |
| Research Site | 33705 | St. Petersburg | Florida |
| Research Site | 32308-5304 | Tallahassee | Florida |
| Research Site | 33401 | West Palm Beach | Florida |
| Research Site | 64132 | Kansas City | Missouri |
| Research Site | 18015 | Bethlehem | Pennsylvania |
| Research Site | 37404 | Chattanooga | Tennessee |
| Research Site | 37203 | Nashville | Tennessee |
| Research Site | 77090 | Houston | Texas |
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