Your session is about to expire
← Back to Search
PD-L1 Inhibitor
Atezolizumab + Cobimetinib for Lung Cancer
Phase 2
Waitlist Available
Led By Stephen V Liu
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer (any histology is permitted)
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest x-ray or as >= 10 mm (>= 1 cm) with CT scan, MRI, or calipers by clinical exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights
Study Summary
This trial is studying a combination of atezolizumab and cobimetinib to treat patients with non-small cell lung cancer.
Who is the study for?
Adults with metastatic, recurrent, or treatment-resistant non-small cell lung cancer who have previously not responded well to anti-PD-1/PD-L1 therapy. Participants must be over 18, have measurable disease, and acceptable organ function. Those with certain gene mutations may join specific cohorts. Pregnant women and individuals with uncontrolled diseases or recent significant adverse events from cancer therapies are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of atezolizumab (an immunotherapy drug) and cobimetinib (a kinase inhibitor for cancers with a mutated BRAF gene) in patients whose lung cancer has spread or resisted previous treatments. The study aims to see if this drug combo is more effective than current standard care.See study design
What are the potential side effects?
Potential side effects include immune-related reactions that can affect organs, fatigue, liver issues, digestive problems like diarrhea and nausea, skin rash, hormonal gland problems leading to hormone imbalances, muscle pain or weakness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to be metastatic or recurrent through testing.
Select...
I have a tumor that can be measured with imaging or physical exam.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I am 18 years old or older.
Select...
My kidneys are working well enough (creatinine clearance >= 30).
Select...
I am willing to have a biopsy for research purposes.
Select...
My cancer does not have a KRAS mutation.
Select...
My cancer has a KRAS mutation as confirmed by a specific test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Biomarker analysis
Duration of response
Grade 3 and 4 toxicities
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (atezolizumab, cobimetinib)Experimental Treatment6 Interventions
Patients receive atezolizumab IV over 30-60 minutes on days 1, and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. Patients also undergo a CT scan, MRI, biopsy, and collection of blood throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~850
Biospecimen Collection
2004
Completed Phase 2
~1730
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Atezolizumab
2017
Completed Phase 3
~5860
Cobimetinib
2017
Completed Phase 3
~2660
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,619 Total Patients Enrolled
Stephen V LiuPrincipal InvestigatorJHU Sidney Kimmel Comprehensive Cancer Center LAO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to drugs similar to atezolizumab or cobimetinib.I do not have another cancer that needs treatment within 2 years, except for certain low-risk types.My lung cancer is confirmed to be metastatic or recurrent through testing.Your hemoglobin level is at least 8 grams per deciliter.I frequently need procedures to remove fluid from my chest or abdomen.I have not had a stroke or mini-stroke in the last 6 months.I am not taking any strong medications that affect liver enzymes.I have a significant liver condition, such as hepatitis or cirrhosis.I have never had lung conditions like pulmonary fibrosis or pneumonitis, except for fibrosis from radiation.You are not able or willing to swallow pills.I have had treatments other than anti-PD-1 or anti-PD-L1 before joining this study.My cancer progressed or I couldn't tolerate treatment for my EGFR, ALK, or ROS1 mutation.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I agree to use birth control during and for 5 months after the study due to risks to a fetus.I do not have a history of long QT syndrome and my heart's QT interval is normal.Your heart's pumping function is not within the normal range, as shown by a recent heart scan.I have not had a serious infection needing treatment in the last 2 weeks.I have a tumor that can be measured with imaging or physical exam.My cancer worsened within 6 months of starting PD-1/PD-L1 inhibitor treatment.I can take care of myself but might not be able to do heavy physical work.You have a low level of white blood cells.You have enough infection-fighting white blood cells in your body.Your platelet count is at least 100,000 per microliter.I haven't taken any immune-weakening medications in the last 2 weeks.I do not have symptoms from cancer spread to my brain.I have not had severe bleeding in the last 4 weeks.I do not have any serious illnesses that would stop me from following the study's requirements.I am 18 years old or older.Your bilirubin levels must be within a certain range, unless you have a condition called Gilbert disease, in which case slightly higher levels are allowed.My blood clotting tests are within normal limits, or I am on a stable dose of blood thinners.I have a history of serious eye conditions that could affect my retina.Your liver enzymes (AST and ALT) should not be more than 3 times the upper limit of normal, or 5 times the upper limit of normal if you have liver involvement.My kidneys are working well enough (creatinine clearance >= 30).I have recovered from side effects of previous cancer treatments, except for hair loss.You are allergic to Chinese hamster ovary cell products or other man-made antibodies.I am willing to have a biopsy for research purposes.I have or am at risk for an autoimmune disease.I haven't had major surgery in the last 28 days and don't expect to need one during the study.I have a condition that affects how my body absorbs food.Your alkaline phosphatase levels are not too high, unless you have liver or bone issues, in which case they can be a bit higher.I am not pregnant or breastfeeding.My cancer does not have a KRAS mutation.My cancer has a KRAS mutation as confirmed by a specific test.I have not received a live vaccine in the last 4 weeks and won't need one during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (atezolizumab, cobimetinib)
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.
Has the FDA granted authorization for Atezolizumab?
"There is existing clinical data that attests to the safety of Atezolizumab, so it was accorded a score of 2."
Answered by AI
How many facilities are involved in the administration of this experiment?
"The clinical trial is recruiting from the University of Oklahoma Health Sciences Center in Oklahoma City, Wake Forest University at Clemmons in North carolina and Moffitt Cancer Centre in Tampa Bay. Additionally, there are an additional 9 medical sites participating."
Answered by AI
How many individuals are receiving treatment as part of this clinical experiment?
"Affirmative. According to information stored on clinicaltrials.gov, this medical trial is actively accepting enrolment. Originally posted in July of 2018 and last updated on November of 2022, the research requires 24 individuals across 9 sites."
Answered by AI
What disease processes can be treated with Atezolizumab?
"Atezolizumab is a commonly prescribed medication to combat certain cases of small cell lung cancer. It may also be used as treatment for metastatic melanoma, unresectable melanoma and other malignant neoplasms."
Answered by AI
Is recruitment still underway for this experiment?
"Based on the clinicaltrials.gov website, this medical trial is still recruiting patients and was initially posted in July 2018 before being updated last November."
Answered by AI
Has there been previous research conducted on Atezolizumab?
"In 2008, the first trials of atezolizumab began taking place in SCRI Tennessee Oncology Chattanooga. At this time, there have been 101 completed studies and 374 ongoing ones across different locations - particularly Oklahoma City, Oklahoma."
Answered by AI
Is this a pioneering endeavor in clinical trials?
"Since 2008, Atezolizumab has been the subject of various medical studies. After its initial Phase 1 trial funded by Hoffmann-La Roche in 2008 involving 720 participants, it received approval for a Phase 2 drug trial and is now being researched across 74 countries with 374 active clinical trials occurring in 1651 cities."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger