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Monoclonal Antibodies
Atezolizumab + Cabozantinib for Non-Small Cell Lung Cancer (CONTACT-01 Trial)
Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Known PD-L1 status or availability of tumor tissue for central PD-L1 testing
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm
Must not have
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (more frequently than once monthly)
Ongoing Grade >= 2 sensory or motor neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is testing a new combination cancer treatment to see if it is more effective and has fewer side effects than current standard treatment.
Who is the study for?
This trial is for adults with metastatic Non-Small Cell Lung Cancer (NSCLC) who have already been treated with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibodies. Participants must be in good physical condition, not have HIV or hepatitis, and agree to use contraception. They cannot join if they've had certain other treatments recently, have severe organ problems, uncontrolled infections or diseases that could interfere with the study.
What is being tested?
The study compares Atezolizumab combined with Cabozantinib against Docetaxel alone in patients whose NSCLC has worsened after previous treatments. It's a Phase III trial where participants are randomly assigned to either treatment group to assess effectiveness and safety.
What are the potential side effects?
Possible side effects include liver issues, high blood pressure, bleeding problems, fatigue, allergic reactions to medication components like polysorbate 80 or Chinese hamster ovary cell products. There may also be risks of infection due to immune system effects from the drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer's PD-L1 status is known or can be tested.
Select...
I agree to not have sex or use birth control, and not donate sperm.
Select...
My cancer progressed after treatment with specific chemotherapy and immunotherapy for advanced lung cancer.
Select...
I am fully active or can carry out light work.
Select...
My lung cancer has spread and was confirmed by a lab test.
Select...
My cancer can be measured by scans and my PD-L1 status is known or can be tested.
Select...
I do not have active hepatitis B.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not need frequent procedures for fluid buildup in my chest or abdomen.
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I have ongoing nerve issues affecting my senses or movement.
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I haven't had significant bleeding or blood clotting issues in the last 3 months.
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I have severe liver problems.
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I have had a previous transplant of stem cells or an organ.
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My high blood pressure is not controlled even with medication.
Select...
My cancer has specific genetic changes that can be treated with approved drugs.
Select...
I have high calcium levels in my blood that are causing symptoms.
Select...
My cancer has not caused any major digestive system issues.
Select...
I have active tuberculosis.
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I cannot swallow pills.
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I am currently taking blood thinners like warfarin, dabigatran, betrixaban, or platelet inhibitors.
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I haven't had a live vaccine in the last 4 weeks and don't plan to during or within 5 months after treatment.
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I have untreated, symptomatic underactive thyroid.
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I have lung lesions with cavities or disease in my airways.
Select...
I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.
Select...
I have pain from my cancer that isn't relieved by medication.
Select...
I am allergic to ingredients in the cabozantinib medication.
Select...
I haven't had major heart problems or unstable heart conditions in the last 3 months.
Select...
I have previously been treated with specific drugs for non-small cell lung cancer.
Select...
I have had leptomeningeal disease.
Select...
I have risk factors for a rare heart rhythm condition.
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I have a serious wound, ulcer, or bone fracture that isn't healing.
Select...
My cancer has a specific genetic change known to respond to certain treatments.
Select...
I have a condition that prevents my body from absorbing nutrients properly.
Select...
I require dialysis.
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I haven't had a stroke, heart attack, or similar event in the last 6 months.
Select...
My cancer has spread to the large blood vessels of my lungs.
Select...
I am currently on medication for hepatitis B.
Select...
I have had lung conditions like pulmonary fibrosis or pneumonitis, or my CT scan shows active pneumonitis.
Select...
I have brain metastases that are untreated or getting worse.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival (OS)
Secondary study objectives
Confirmed Objective Response Rate (ORR) as Determined by Investigator
Duration of Response (DOR) as Determined by Investigator
OS Rates
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Atezolizumab + CabozantinibExperimental Treatment2 Interventions
Participants received atezolizumab on Day 1 of each 21-day cycle and cabozantinib orally once daily on Days 1-21 of each cycle.
Group II: DocetaxelActive Control1 Intervention
Participants received docetaxel on Day 1 of each 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860
Cabozantinib
2020
Completed Phase 2
~1760
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,456 Previous Clinical Trials
1,097,246 Total Patients Enrolled
ExelixisIndustry Sponsor
120 Previous Clinical Trials
19,764 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,225 Previous Clinical Trials
895,994 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not need frequent procedures for fluid buildup in my chest or abdomen.I have ongoing nerve issues affecting my senses or movement.I haven't had any major abdominal issues like fistulas or obstructions in the last 6 months.I have recovered from previous cancer treatment side effects, or they are stable and not serious.My cancer's PD-L1 status is known or can be tested.I haven't had significant bleeding or blood clotting issues in the last 3 months.I have severe liver problems.I agree to not have sex or use birth control, and not donate sperm.You are pregnant, breastfeeding, planning to get pregnant, or will have a baby within a few months after the study treatment ends.I have had a previous transplant of stem cells or an organ.Your heart's electrical activity, as measured by an ECG, is abnormal.I do not have an active or history of severe autoimmune disease, but controlled thyroid issues, Type 1 diabetes, or mild skin conditions are okay.I haven't taken strong immune system medications recently, except for certain low-dose or specific conditions.I have not had a severe infection or been hospitalized for one in the last 4 weeks.I have no other active cancers or any diagnosed in the last 3 years needing treatment, except for certain skin, prostate, cervix, or breast cancers.I have not taken any antibiotics by mouth or IV in the last 2 weeks.My high blood pressure is not controlled even with medication.My cancer progressed after treatment with specific chemotherapy and immunotherapy for advanced lung cancer.My cancer has specific genetic changes that can be treated with approved drugs.I have high calcium levels in my blood that are causing symptoms.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.My cancer has not caused any major digestive system issues.I have active tuberculosis.I cannot swallow pills.I am currently taking blood thinners like warfarin, dabigatran, betrixaban, or platelet inhibitors.I haven't had a live vaccine in the last 4 weeks and don't plan to during or within 5 months after treatment.I have untreated, symptomatic underactive thyroid.My blood and organs are functioning well.I have lung lesions with cavities or disease in my airways.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.You have rare inherited conditions that affect how your body processes galactose or glucose.I am fully active or can carry out light work.I have pain from my cancer that isn't relieved by medication.I am allergic to ingredients in the cabozantinib medication.I haven't had major heart problems or unstable heart conditions in the last 3 months.I have previously been treated with specific drugs for non-small cell lung cancer.I have had leptomeningeal disease.I have risk factors for a rare heart rhythm condition.I have a serious wound, ulcer, or bone fracture that isn't healing.Your disease can be measured by the doctor using specific guidelines.You have had a bad reaction to docetaxel or other drugs containing polysorbate 80.My cancer has a specific genetic change known to respond to certain treatments.I have a condition that prevents my body from absorbing nutrients properly.I require dialysis.My lung cancer has spread and was confirmed by a lab test.My cancer can be measured by scans and my PD-L1 status is known or can be tested.You are allergic to Chinese hamster ovary cell products or any part of the atezolizumab medication.I haven't had a stroke, heart attack, or similar event in the last 6 months.I have recovered from major side effects of previous treatments, or they are stable and not serious.My cancer has spread to the large blood vessels of my lungs.You have had serious allergic reactions to certain types of medications made from human or animal proteins.I am currently on medication for hepatitis B.I have not had major blood vessel problems in the last 6 months.You tested negative for hepatitis B surface antigen (HBsAg) during screening.I do not have active hepatitis B.You have tested negative for HIV during the screening process.I have had lung conditions like pulmonary fibrosis or pneumonitis, or my CT scan shows active pneumonitis.I have brain metastases that are untreated or getting worse.You need to have a negative test for hepatitis C virus (HCV) or a positive test followed by a negative viral RNA test.
Research Study Groups:
This trial has the following groups:- Group 1: Docetaxel
- Group 2: Atezolizumab + Cabozantinib
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
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