Study on Maintenance Chemotherapy With or Without Local Therapy for Stage IV Non-small Cell Lung Cancer
Sponsor: NRG Oncology
ClinicalTrials ID:NCT03137771
This clinical trial is exploring whether adding local treatments like radiation or surgery to standard maintenance chemotherapy can improve outcomes for patients with stage IV non-small cell lung cancer.
Patient Parameters
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Program Overview
The study aims to find out if combining maintenance chemotherapy with local treatments, such as radiation or surgery, is more effective than chemotherapy alone for patients with stage IV non-small cell lung cancer. Maintenance chemotherapy uses drugs like docetaxel, pemetrexed, erlotinib, and gemcitabine to stop cancer cells from growing. Local treatments aim to eliminate any remaining cancer cells after initial treatment. Researchers hope that this combination will better control the cancer.
Description
The study is divided into two phases. In Phase II, researchers will see if adding local treatments to maintenance chemotherapy helps patients live longer without the cancer getting worse. In Phase III, they will check if this combination helps patients live longer overall.
Secondary goals include:
- Checking if local treatments reduce cancer returning in treated areas.
- Seeing if local treatments delay the appearance of new cancer spots.
- Evaluating any side effects from adding local treatments.
- Assessing how long patients can stay on maintenance chemotherapy.
- Understanding how local treatments affect patients' quality of life.
- Collecting blood samples to study the relationship between treatment outcomes and cancer DNA in the blood.
Patients will be randomly assigned to receive either chemotherapy alone or chemotherapy with local treatments. After treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years, and annually after that.
Eligibility Criteria
Inclusion Criteria
- Must be able to complete the study and follow-up visits.
- Women and men who are sexually active must use effective birth control during the study and for 180 days after treatment.
- Must have stage IV non-small cell lung cancer with up to 3 sites of cancer spread.
- Must have had a physical exam and imaging tests to confirm limited cancer spread and stable disease.
- Must have good overall health with a performance status of 0, 1, or 2.
- Must have adequate organ function based on blood tests.
- HIV-positive patients can participate if their viral load is undetectable.
- Women must have a negative pregnancy test before joining the study.
- Must have received initial chemotherapy and/or immunotherapy and achieved stable disease or partial response.
- Must have at least one cancer site that can be treated with local therapy.
- Previous treatments for earlier stages of lung cancer or other cancers are allowed.
- Must provide informed consent to participate.
Exclusion Criteria
- Untreated or worsening brain cancer spread after initial treatment.
- Skin cancer spread from lung cancer.
- Cancer spread to digestive organs if not treatable with surgery.
- History of other invasive cancers unless disease-free for at least one year.
- Cancer spread near previously irradiated areas if not treatable with surgery.
- Receiving targeted therapy for lung cancer in the first-line setting.
- Lung cancer with specific mutations treatable with targeted therapies.
- Cancer that has returned in areas previously treated with high-dose radiation.
- Unresolved fluid buildup in the chest after initial treatment.
- More than 3 separate cancer spread locations after initial treatment.
- Active infections requiring IV antibiotics.
- Pregnant or breastfeeding women, or those not using effective birth control.
- Participation in another cancer drug study within 4 weeks before joining.
- Use of certain medications like steroids or immunosuppressants if received in the past 2 years.
- Use of antiangiogenic therapy like bevacizumab in initial or planned maintenance treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Arizona Center for Cancer Care - Gilbert | 85297 | Gilbert | Arizona |
| Arizona Center for Cancer Care-Peoria | 85381 | Peoria | Arizona |
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| Arizona Center for Cancer Care - Scottsdale | 85258 | Scottsdale | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| University of Arizona Cancer Center-Orange Grove Campus | 85704 | Tucson | Arizona |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
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