Study on Nivolumab With or Without Ipilimumab for Treating Recurrent Stage IV Squamous Cell Lung Cancer
Sponsor: SWOG Cancer Research Network
ClinicalTrials ID:NCT02785952
This clinical trial is comparing two treatments for patients with stage IV squamous cell lung cancer that has returned after previous treatment. The study aims to find out if nivolumab works better alone or when combined with ipilimumab.
Patient Parameters
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Program Overview
This study is testing two different treatments for patients with stage IV squamous cell lung cancer that has come back after treatment. The treatments involve using drugs called monoclonal antibodies, specifically nivolumab and ipilimumab, which may help shrink tumors. The study will compare the effectiveness of nivolumab alone versus nivolumab combined with ipilimumab to see which works better for these patients.
Description
The main goal of this study is to compare the overall survival of patients with advanced squamous cell lung cancer who receive either nivolumab alone or nivolumab with ipilimumab. Researchers will also look at how long patients live without the cancer getting worse and how well the tumors respond to the treatments. Additionally, the study will monitor any side effects from the treatments and evaluate patient-reported outcomes.
Participants will be randomly assigned to one of two groups. One group will receive nivolumab and ipilimumab, while the other group will receive nivolumab alone. Treatments are given through an IV every two weeks, with ipilimumab added every six weeks for the combination group. Patients will continue treatment as long as it is effective and side effects are manageable.
After finishing the study treatment, patients will have regular follow-up visits to monitor their health and any changes in their cancer. These visits will occur every three months for the first year, then every six months for up to three years. If the cancer progresses, follow-up visits will continue every six months for two years and at the end of the third year.
Eligibility Criteria
Inclusion Criteria
- Must meet all eligibility criteria for the Lung-MAP study for previously treated squamous cell lung cancer.
- Must be assigned to this specific sub-study (S1400I).
- Must not have had previous treatment with certain immune-targeting drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies.
- Must not have active autoimmune diseases, except for certain conditions like vitiligo, type I diabetes, or hypothyroidism that only require hormone replacement.
- Must not have allergies to components of nivolumab or ipilimumab.
- Must not have used systemic corticosteroids or other immunosuppressive medications recently, except for certain low-dose or topical steroids.
- Must not have active hepatitis B or C infections, or HIV/AIDS.
- Must not have symptomatic interstitial lung disease.
- Must agree to provide samples for future research.
- Must have certain lab tests done within seven days before starting the study.
- Must not have severe heart disease or recent heart attacks.
- Must be able to complete patient questionnaires in English, if enrolled after September 1, 2016.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| 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 Regional Hospital | 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 |
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