Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative (NCT04929041)

🧪 Interventions in This Study

• Ipilimumab (BIOLOGICAL)
• Nivolumab (BIOLOGICAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Histologic or cytologic diagnosis of stage IV NSCLC using version American Joint Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease). Patients with stage IIIB and IIIC disease are eligible if they are not a candidate for combined chemotherapy and radiation
2. PD-L1 expression tumor proportion score (TPS) \< 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed patients are not eligible. The assay must have been performed locally by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory. The type of assay will be recorded
3. For non-squamous patients only (adenocarcinoma or adenosquamous): EGFR, ALK and ROS1 testing must be done locally. No patients with known actionable EGFR mutations (except exon 20 insertion), ALK or ROS1 mutations that can be treated with oral tyrosine inhibitors
4. Measurable disease based on RECIST 1.1, including at least two cancerous deposits. At least one deposit must be RECIST measurable (and not to be irradiated) while at least one OTHER deposit (measurable or non-measurable) must meet criteria for three 8 gray (Gy) doses of radiation
5. Age \>= 18 years
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
7. No more than three weeks of treatment with systemic chemotherapy or immunotherapy for advanced NSCLC
8. No more than three weeks of treatment with checkpoint inhibitors for metastatic lung cancer
9. No treatment with chemotherapy or immunotherapy for non-metastatic disease (e.g., adjuvant therapy) within 6 months prior to registration
10. No systemic immunostimulatory or immunosuppressive drugs, including \> 10 mg prednisone equivalent per day, within 2 weeks or 5 half-live of the drug, whichever is shorter. Steroid premedication per local standard is allowed
11. \>= 1 week prior to registration since palliative (including central nervous system \[CNS\]) radiotherapy to any tumor site
12. No prior allogeneic tissue/solid organ transplant

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (169 Sites)

Showing the first 25 of 169 sites.

• Mayo Clinic Hospital in Arizona — Phoenix, Arizona
• University of Arkansas for Medical Sciences — Little Rock, Arkansas
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California
• City of Hope Comprehensive Cancer Center — Duarte, California
• City of Hope at Irvine Lennar — Irvine, California
• City of Hope Antelope Valley — Lancaster, California
• Fremont - Rideout Cancer Center — Marysville, California
• Memorial Medical Center — Modesto, California
• Providence Queen of The Valley — Napa, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• City of Hope South Pasadena — South Pasadena, California
• Gene Upshaw Memorial Tahoe Forest Cancer Center — Truckee, California
• City of Hope Upland — Upland, California
• UCHealth Memorial Hospital Central — Colorado Springs, Colorado
• Memorial Hospital North — Colorado Springs, Colorado
• Poudre Valley Hospital — Fort Collins, Colorado
• Cancer Care and Hematology-Fort Collins — Fort Collins, Colorado
• UCHealth Greeley Hospital — Greeley, Colorado
• Medical Center of the Rockies — Loveland, Colorado
• Beebe South Coastal Health Campus — Millville, Delaware
• Helen F Graham Cancer Center — Newark, Delaware
• Medical Oncology Hematology Consultants PA — Newark, Delaware
• Beebe Health Campus — Rehoboth Beach, Delaware
• MedStar Washington Hospital Center — Washington D.C., District of Columbia
• UM Sylvester Comprehensive Cancer Center at Aventura — Aventura, Florida

📞 Contact the Study Coordinator

Phone: (800) 664-4580

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity or patients may receive standard of care systemic immunotherapy.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.