A Multi-center Phase II Study of Combining Cabozantinib and Atezolizumab as the 1st Line Therapy for PD-L1 Negative Advanced/Metastatic NSCLC (Cabatezo-1)
Jun Zhang, MD, PhD
Summary
NSCLC patients with low expression level of PD-L1, esp. those with its level less than 1%, do not derive much benefit from anti-PD-1/L1 therapy (e.g. atezoilzumab). In this study, investigators hypothesize that the combination of cabozantinib (a multi-kinase inhibitor) and atezolizumab will result in better therapeutic value.
Description
For metastatic/advanced non-small cell (NSCLC) patients who do not have targetable mutations, the combination of chemotherapy with immunotherapy targeting the programmed death-1 and its ligand (PD-1/L1) is now a standard of care. In addition, recent studies also demonstrated that immunotherapy doublet using anti-PD-1 agent nivolumab and anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) agent ipilimumab could be another valid option. However, largely due to the immunosuppressive tumor microenvironment, the therapeutic response remains suboptimal in NSCLC patients with PD-L1 tumor propor…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA: * Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent * Males and females age ≥ 18 years * ECOG Performance Status 0 - 1 * Pathologically confirmed advanced/metastatic NSCLC, with PD-L1\<1% based on IHC using 22C3 antibody * At least one target lesion that can be assessed by RECIST 1.1 * For candidates who are not qualified for upfront FDA-approved targeted therapy, must be systemic treatment naïve (local palliative RT more than 4 weeks prior is allowed) * For cand…
Interventions
- DrugCabozantinib
Oral once per day, Days 1 - 21 every 21 days
- DrugAtezolizumab
Intravenous (IV) once every 21 days
Locations (4)
- The University of Kansas Cancer Center - WestwoodKansas City, Kansas
- The University of Kansas Cancer Center - Indian CreekOverland Park, Kansas
- The University of Kansas Cancer Center - NorthKansas City, Missouri
- The University of Kansas Cancer Center - Lee's SummitLee's Summit, Missouri