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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Cabatezo-1 Trial 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.Check my eligibility
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.See study design
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.
Cabatezo-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Cabatezo-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Drug Safety
Duration of response (DOR)
Overall survival (OS)
+1 moreCabatezo-1 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
~1080
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,540 Previous Clinical Trials
567,859 Total Patients Enrolled
Jun Zhang, MD, PhDLead Sponsor
4 Previous Clinical Trials
175 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,511 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had major surgery less than 2 weeks ago or my surgical wound has not fully healed.My advanced lung cancer has low PD-L1 levels, confirmed by a specific test.I have serious heart problems that are not under control.I have not received any live vaccines in the last 4 weeks and will not during or for 5 months after my atezolizumab treatment.I haven't had any cancer treatment in the last 4 weeks.I have previously been treated with specific immune therapies.I haven't had a severe infection in the last 2 weeks.You have at least one specific area of the body that can be measured and evaluated using a specific method.I or my legal representative can understand the study and agree to sign the consent.I am 18 years old or older.I haven't had a severe infection or been hospitalized for one in the last 4 weeks.I have healed from any major or minor surgeries before starting the study treatment.My cancer did not respond to the first line of FDA-approved targeted therapy.I am on certain blood thinners not linked to major bleeding issues.I am not pregnant and cannot become pregnant, confirmed by tests or medical history.My calcium levels are not higher than normal and I don't have symptoms of high calcium.My cancer is growing into or around major blood vessels.I agree not to father a child or donate sperm during and for 6 months after the study.I am fully active or can carry out light work.I do not need frequent procedures to remove excess fluid from my body.My side effects from previous treatments are mild or gone.My organs are working well.I do not have active hepatitis B or C, or if I do, it's being treated and under control.My brain metastases are stable, treated, and I'm not on high-dose steroids.I haven't had radiation or radionuclide treatment in the last 4-6 weeks.I have not taken antibiotics for treatment in the last 2 weeks, only for prevention.I do not have another cancer that could interfere with the study.I have or had an autoimmune disease or immune deficiency.I have been treated with cabozantinib and/or atezolizumab before.You have other serious health problems that could make it unsafe for you to be in the study.I have not failed a targeted therapy for my cancer's specific mutation.I am HIV negative or, if positive, I am stable on treatment with good immune function and undetectable viral load.My cancer has spread to the lining of my brain and spinal cord.I have pain from my cancer that isn't relieved by treatment.I haven't taken any kinase inhibitor medication in the last 2 weeks.I cannot swallow pills or receive treatments through an IV.I can provide a sample of my tumor for research, and I'm open to a biopsy if it's safe.I haven't had systemic treatment for my condition, except for local palliative radiation therapy over 4 weeks ago.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have not had significant bleeding or coughed up more than half a teaspoon of blood in the last 3 months.You have had a bad reaction to Chinese hamster ovary cell products or the study treatment in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib and Atezolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are Cabozantinib and Atezolizumab associated with any adverse effects for patients?
"While there is a certain level of clinical evidence indicating the safety of cabozantinib and atezolizumab, efficacy data is still lacking so these treatments obtained an estimate score of 2."
Answered by AI
Are any new participants being admitted to this research project?
"As per the information on clinicaltrials.gov, this particular experiment is no longer enrolling participants; its initial posting was December 1st 2023 and it has last been edited May 12th 2023. Although not actively recruiting currently, there are still 2,091 studies that require candidates to join them."
Answered by AI
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