The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial 2 (SPRINT 2)
Montefiore Medical Center
Summary
This is a randomized trial evaluating the efficacy and safety of sequential dual-agent immunotherapy and risk-adapted radiotherapy for patients with locally advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score of at least 50%. Participants will be randomized between two dual-agent immunotherapy regimens: durvalumab + monalizumab versus durvalumab + oleclumab.
Description
Lung cancer is the leading cause of cancer-related death worldwide, with more than 1.5 million deaths per year. Non-small-cell lung cancer (NSCLC) represents more than 80% of lung cancers, and approximately one-third of NSCLC patients present with stage III disease. Locally advanced non-small cell lung carcinoma (LA-NSCLC) includes stage III NSCLC and unresectable stage II NSCLC. For several decades, standard treatment for patients with LA-NSCLC consisted of conventionally fractionated (1.8-2.0 Gy/day) radiotherapy to a total dose of approximately 60 Gy with concurrent chemotherapy. Based on t…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations. 2. Patient is willing and able to comply with the protocol for the duration of the study, including undergoing treatment and scheduled visits and e…
Interventions
- DrugDurvalumab
Durvalumab is a human mAb of the immunoglobulin G 1 kappa subclass that blocks the interaction of PD-L1 (but not PD-L2) with PD 1 on T cells and CD80 (B7.1) on immune cells.
- DrugMonalizumab
Monalizumab is a humanized mAb of the IgG4 subtype that specifically binds and inhibits Cluster of Differentiation 94 (CD94)/NK cell protein group 2 A(NKG2A).
- DrugOleclumab
Oleclumab is a human IgG1λ mAb that selectively binds to and inhibits the ectonucleotidase activity of CD73.
- RadiationRadiotherapy
PET based dose painted radiotherapy. If these treatment techniques are not available for some reason treatment may be delivered using a sequential boost technique (2.75 Gy x 17 to the low-risk PTV followed by 2.75 Gy x 3 to the high-risk planning target volume).
Location
- Montefiore Medical CenterThe Bronx, New York