← Back to Search

PD-L1 Inhibitor

Cabozantinib + Atezolizumab for Lung Cancer (Cabatezo-1 Trial)

Phase 2
Waitlist Available
Research Sponsored by Jun Zhang, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed advanced/metastatic NSCLC, with PD-L1<1% based on IHC using 22C3 antibody
For candidates who are qualified for upfront FDA-approved targeted therapy (e.g. having sensitizing mutations in EGFR, ALK and BRAF, etc.), treatment must have failed and received at least one line of ONLY FDA-approved targeted therapy
Must not have
Undergone major surgery within 2 weeks prior to the start of study regimen, or has not achieved complete wound healing
The participant has uncontrolled, significant cardiovascular disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial investigates if combining cabozantinib and atezolizumab can increase benefits for NSCLC patients with low PD-L1 expression, esp. <1%.

Who is the study for?
Adults with advanced/metastatic non-small cell lung cancer (NSCLC) and low PD-L1 expression (<1%) who haven't benefited from anti-PD-1/L1 therapy. They must have recovered from previous treatments, not be pregnant or breastfeeding, use contraception, and have no other cancers that could affect the trial. HIV-positive patients can join if stable on antiretroviral therapy.
What is being tested?
The study tests a combination of Cabozantinib (a drug that inhibits multiple kinases) and Atezolizumab (an immunotherapy drug) to see if they work better together for NSCLC patients with low PD-L1 expression levels than current therapies.
What are the potential side effects?
Possible side effects include liver issues, high blood pressure, hand-foot syndrome (redness and pain in hands/feet), fatigue, mouth sores, hair color changes, taste changes, digestive problems like diarrhea or nausea; also increased risk of infections due to immune system effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My advanced lung cancer has low PD-L1 levels, confirmed by a specific test.
Select...
My cancer did not respond to the first line of FDA-approved targeted therapy.
Select...
I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I had major surgery less than 2 weeks ago or my surgical wound has not fully healed.
Select...
I have serious heart problems that are not under control.
Select...
I have not received any live vaccines in the last 4 weeks and will not during or for 5 months after my atezolizumab treatment.
Select...
I have previously been treated with specific immune therapies.
Select...
I haven't had a severe infection in the last 2 weeks.
Select...
I haven't had radiation or radionuclide treatment in the last 4-6 weeks.
Select...
I haven't had a severe infection or been hospitalized for one in the last 4 weeks.
Select...
My calcium levels are not higher than normal and I don't have symptoms of high calcium.
Select...
My cancer is growing into or around major blood vessels.
Select...
I have or had an autoimmune disease or immune deficiency.
Select...
I have been treated with cabozantinib and/or atezolizumab before.
Select...
My cancer has spread to the lining of my brain and spinal cord.
Select...
I have pain from my cancer that isn't relieved by treatment.
Select...
I cannot swallow pills or receive treatments through an IV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Drug Safety
Duration of response (DOR)
Overall survival (OS)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cabozantinib and AtezolizumabExperimental Treatment2 Interventions
Cabozantinib 40mg po daily + Atezolizumab 1200mg iv on day 1; 1 cycle = 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~1760
Atezolizumab
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,556 Previous Clinical Trials
569,353 Total Patients Enrolled
Jun Zhang, MD, PhDLead Sponsor
4 Previous Clinical Trials
175 Total Patients Enrolled
ExelixisIndustry Sponsor
120 Previous Clinical Trials
20,090 Total Patients Enrolled

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05859217 — Phase 2
Lung Cancer Research Study Groups: Cabozantinib and Atezolizumab
Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05859217 — Phase 2
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05859217 — Phase 2
~27 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top