A Study of Combining Cabozantinib and Atezolizumab for Advanced/Metastatic NSCLC (Cabatezo-1)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJun Zhang, MD, PhD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Simultaneously enrolled in any therapeutic clinical trial
Current or anticipating use of other investigational agents while participating in this study
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
Trial design
Design model
Single group
Treatments tested in this trial
Cabozantinib
DrugOral once per day, Days 1 - 21 every 21 days
Atezolizumab
DrugIntravenous (IV) once every 21 days
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Cabozantinib and AtezolizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
From baseline to End of Treatment (EOT) due to disease progression using RECIST criteria 1.1
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Duration of response (DOR)
The response to the study drugs will be determined using RECIST criteria 1.1
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months2
Progression-free survival (PFS)
The lack of progression will be dertermined using RECIST criteria 1.1
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months3
Overall survival (OS)
Medical Record will be followed to watch survival status
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months4
Drug Safety
Safety of drugs will be determined by documenting adverse events and the severity of adverse events will be documented using CTCAE Version 5.0
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jun Zhang, MD, PhD
Lead sponsor
University of Kansas Medical Center
Sponsor institution
Exelixis
Collaborator
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: