Study on Volrustomig with Other Cancer Drugs for Advanced Non-Small Cell Lung Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT06448754
This clinical trial is exploring the safety and effectiveness of a new drug, volrustomig, when used with other cancer treatments in patients with advanced non-small cell lung cancer (NSCLC) who have not received prior treatment for their condition.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how safe and effective the drug volrustomig is when combined with other cancer medications in patients with advanced non-small cell lung cancer (NSCLC). Participants in this study have not received any previous treatment for their advanced cancer. The study will compare two different treatment plans to see which works better.
Description
This study is being conducted at multiple centers around the world and involves patients with Stage IV non-squamous non-small cell lung cancer (NSQ NSCLC) who have not been treated for their advanced cancer before. Participants will be randomly assigned to one of two treatment groups, where they will receive volrustomig along with chemotherapy. The study aims to understand the safety, how the body processes the drug, and its effectiveness in fighting cancer.
Eligibility Criteria
Inclusion Criteria
- Must be in good general health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Expected to live at least 12 more weeks.
- Have good organ and bone marrow function.
- Weigh more than 35 kilograms (about 77 pounds).
- Have a confirmed diagnosis of non-squamous non-small cell lung cancer (NSQ NSCLC).
- Do not have certain genetic mutations that are typically treated with specific targeted therapies.
- Have at least one tumor that can be measured and has not been treated with radiation.
Exclusion Criteria
- Have spinal cord compression.
- Have a history of immune system disorders.
- Have active or past autoimmune or inflammatory diseases.
- Have a mix of small-cell lung cancer and non-small cell lung cancer or a sarcomatoid variant.
- Have brain metastases unless they are stable, not causing symptoms, and do not require steroids for at least 14 days before starting the study. At least 2 weeks must have passed since the end of any radiation therapy.
- Have received prior chemotherapy or other treatments for Stage IV NSCLC, unless it was more than 12 months ago and was for earlier stages of the disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 90067 | Los Angeles | California |
| Research Site | 81501 | Grand Junction | Colorado |
| Research Site | 80033 | Wheat Ridge | Colorado |
| Research Site | 21231 | Baltimore | Maryland |
| Research Site | 48202 | Detroit | Michigan |
| Research Site | 27514 | Chapel Hill | North Carolina |
| Research Site | 98405 | Tacoma | Washington |
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