A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)
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- STATUS
- Recruiting
Summary
This is an open-label, randomized (1:1), multicenter, Phase 3 clinical trial evaluating the safety and efficacy of nivolumab in combination with investigational agent sitravatinib compared to docetaxel in patients with advanced non-squamous NSCLC who have previously experienced radiographic disease progression on or after treatment with platinum-based chemotherapy in combination with CIT.
Description
Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs, including the TAM family (TYRO3, AXL and MERTK), VEGFR2, KIT and MET.
Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response.
RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy.
Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.
Details
| Condition | Lung Cancer, Non-Small Cell Lung Cancer |
|---|---|
| Clinical Study Identifier | TX223045 |
| Last Modified on | 4 May 2022 |
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