This phase 2 trial will investigate the effect of gemcitabine (Gemzar) and nivolumab (Opdivo) in patients with metastatic small-cell lung cancer (SCLC).
The main outcome will be the radiographic response rate (RRR). This trial is recruiting in North Carolina, US.
Small cell lung cancer (SCLC) is the most aggressive form of LC. It can be difficult to treat. Chemotherapy (CT) is a standard treatment for most cancers. Combining CT with new treatment strategies may improve survival in SCLC. Immunotherapy (IT) with immune checkpoint inhibitors (ICIs) is a new treatment option for advanced cancer. Combining CT and IT may improve survival. Gemcitabine is a CT drug. It stops all cells from dividing. This kills both normal cells and cancer cells.Nivolumab is an ICI that targets the PD-1 receptor. This allows the immune system to detect and kill cancer cells.
This trial will investigate the effect of gemcitabine and nivolumab combination in patients with SCLC. The main outcome will be the RRR.
Who are they looking for?
This trial will recruit 29 patients with advanced SCLC. Patients must have had previous treatment with platinum-based CT (such as cisplatin or carboplatin). Participants must have adequate bone marrow function tests. Highly effective methods of contraception must be used by women of childbearing potential.
Patients cannot take part in the trial if they have been treated withgemcitabine or nivolumab before. Allergy to either drug is another exclusion criteria. Patients with uncontrolled illnesses cannot take part in the trial. This includes heart issues or ongoing infections. Pregnant women are excluded from the trial.
How will it work
All patients will be treated with gemcitabine and nivolumab. Both drugs will be administered via an intravenous infusion. This will be done every 2 weeks. 4 courses of treatment will be administered unless the disease progresses or cannot be tolerated.
The main outcome will be the RRR at 8 weeks. Survival will also be measured up to 2 years.