Nivolumab and Ipilimumab With or Without Local Consolidation Therapy in Treating Patients With Stage IV Non-Small Cell Lung Cancer (NCT03391869)

🧪 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. Histologically or cytologically confirmed non-small cell lung cancer; if a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected lung cancer may be consented, but pathology must be confirmed prior to initiating treatment on study. Neuroendocrine carcinomas (e.g. small cell lung cancer \[SCLC\], carcinoid tumors) are not eligible. Carcinomas with neuroendocrine differentiation are eligible.
2. Stage IV (according to the American Joint Committee on Cancer \[AJCC\] 8th edition) measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
3. Signed and dated written or remote informed consent prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation.
4. For lung adenocarcinoma patients, patients must not harbor any EGFR sensitizing or ALK fusion where there are standard care therapy options available. For patients with histologies other than adenocarcinoma, EGFR and ALK status is not required. Adenocarcinoma patients may be consented prior to the EGFR and ALK status being known, but EGFR and ALK status must be determined prior to initiating therapy. EGFR and ALK status may be determined using either tumor- or plasma-based, Clinical Laboratory Improvement Amendments (CLIA)-certified assays. For patients with non-small cell lung cancer (NSCLC), not otherwise specified (NOS), EGFR/ALK testing is not required, as the frequency of alterations is exceedingly rare in this histology. Also, note that patients with ROS1/RET alterations can be enrolled, as tyrosine kinase inhibitor such as crizotinib aren't established as first line therapy for patients with these alterations.
5. One prior line of chemotherapy and/or targeted agents for metastatic disease are permitted. This chemotherapy can include maintenance therapy, as long as it was given in the front line setting. In addition, prior antiangiogenic therapy (e.g. bevacizumab) is permitted if used as frontline treatment. Patients must have organ and marrow function as defined below:
6. Performance status of 0 or 1 if using Eastern Cooperative Oncology Group (ECOG)/Zubrod.
7. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to treatment initiation
8. White blood cell (WBC ) \>= 2000/uL
9. Neutrophils \>= 1500/uL (obtained within 14 days prior to randomization/registration)
10. Platelets \>= 100 x 10\^3/uL (obtained within 14 days prior to randomization/registration)
11. Hemoglobin \> 9.0 g/dL (obtained within 14 days prior to randomization/registration)
12. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 50 mL (if using the Cockcroft-Gault formula)

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

📍 All Participating Trial Locations (5 Sites)

• MD Anderson in The Woodlands — Conroe, Texas
• M D Anderson Cancer Center — Houston, Texas
• MD Anderson West Houston — Houston, Texas
• MD Anderson League City — League City, Texas
• MD Anderson in Sugar Land — Sugar Land, Texas

📞 Contact the Study Coordinator

Phone: (877) 632-6789

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: =\< 1 cm) brain metastases are 1) eligible provided that the patient is off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior...

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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.