2N-16-3: A Phase 2, Fast Real-time Assessment of Combination Therapies in Immuno-Oncology Study in Subjects with Advanced Non-small Cell Lung Cancer (FRACTION-Lung)
DescriptionThe purpose of this study is to determine whether Nivolumab, in combination with other therapies, is more effective than Nivolumab by itself in patients with advanced Non-Small Cell lung cancer.
PhasePhase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.
Inclusion and Exclusion Criteria
- Advanced Non Small Cell Lung Cancer (NSCLC)
- Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1
- Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy treatment
- Must have at least 1 lesion with measurable disease
- Subjects with certain mutations that have not been treated with a targeted therapy prior to enrollment
- Subjects who need daily oxygen therapy
- People with autoimmune disease Other protocol defined inclusion/exclusion criteria could apply
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.