Study on Adding an Antibody to Standard Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04092283
This clinical trial is exploring whether adding the antibody durvalumab to standard chemotherapy and radiation therapy can improve treatment outcomes for patients with stage III non-small cell lung cancer that cannot be removed by surgery.
Patient Parameters
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Program Overview
This study is testing if the antibody durvalumab, when combined with chemotherapy and radiation therapy, can help the immune system better attack stage III non-small cell lung cancer that cannot be surgically removed. The goal is to see if this combination can extend patients' lives and prevent the cancer from returning, compared to the usual treatment of chemotherapy and radiation followed by durvalumab alone.
Description
The main goal of this study is to see if adding durvalumab to chemotherapy and radiation therapy can improve overall survival for patients with stage III non-small cell lung cancer. Researchers will also look at how well the cancer responds to this treatment, how long patients live without the cancer getting worse, and if the cancer comes back less often. They will also check for any side effects from the treatment.
In the first part of the study, patients will be randomly assigned to one of two groups. One group will receive durvalumab along with chemotherapy and radiation, while the other group will receive only chemotherapy and radiation. After this initial treatment, all patients will receive durvalumab for one year.
Patients will be monitored regularly after treatment to check their health and see how well the treatment is working. Follow-up visits will occur every three months for the first two years, every six months for the next three years, and then once a year for up to ten years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have stage III non-small cell lung cancer that cannot be removed by surgery, or have had a recurrence of cancer in the lymph nodes after surgery.
- Be in good overall health with an ECOG performance status of 0 or 1.
- Weigh more than 30 kg.
- Have not lost more than 10% of body weight unintentionally in the last 30 days.
- Have a recent ECG and imaging tests showing measurable disease.
- Have adequate blood cell counts and organ function based on specific lab tests.
- Have good lung function and be expected to have a safe level of lung exposure to radiation.
- Not have received prior chemotherapy or radiation for this cancer, except under specific conditions.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after treatment.
- Men must agree to use effective contraception during and after treatment.
Exclusion Criteria
- Have active autoimmune diseases or certain neuromuscular disorders.
- Have a history of hepatitis B or C, tuberculosis, or severe infections.
- Have had recent treatment with certain immune-stimulating or investigational drugs.
- Have severe allergies to antibodies or fusion proteins.
- Have had a bone marrow or organ transplant.
- Have certain lung diseases or have had prior treatment with specific immune therapies.
- Have significant heart disease or other serious health conditions.
- Have received a live vaccine recently.
- Have had prior radiation to the current treatment site.
- Must not donate blood or sperm during the study.
- Must not receive other cancer treatments during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Banner MD Anderson Cancer Center | 85234 | Gilbert | Arizona |
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