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Immunotherapy
Docetaxel + Bintrafusp Alfa for Lung Cancer
Phase 2
Waitlist Available
Led By Konstantinos Leventakos, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing docetaxel with or without bintrafusp alfa to see if it is more effective in treating patients with non-small cell lung cancer that has spread.
Who is the study for?
Adults with advanced non-small cell lung cancer who have previously received anti-PD1/PD-L1 and chemotherapy. Participants must be over 18, not pregnant or nursing, willing to use contraception, and able to provide consent. They should have adequate organ function as indicated by specific blood tests and no severe allergies or conditions that would interfere with the trial.Check my eligibility
What is being tested?
The trial is testing the effectiveness of docetaxel chemotherapy with or without bintrafusp alfa (an immunotherapy drug) in treating advanced non-small cell lung cancer. It's a phase II study where patients are randomly assigned to receive either both drugs together or just docetaxel alone.See study design
What are the potential side effects?
Docetaxel can cause side effects like fatigue, hair loss, nausea, and low blood cell counts leading to increased infection risk. Bintrafusp alfa may lead to immune-related side effects such as inflammation in various organs, skin reactions, hormonal gland problems, and infusion-related reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival (PFS) of bintrafusp alfa in combination with docetaxel versus (vs) docetaxel alone
Secondary outcome measures
Confirmed response rates
Duration of response
Incidence of adverse events
+1 moreOther outcome measures
Mutation types and numbers in plasma or in tumor tissue
Potential predictive biomarker analysis of genes or gene signatures
Predicative marker potential of PD-L1 and TGFbeta
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (docetaxel, bintrafusp alfa)Experimental Treatment2 Interventions
Patients receive docetaxel IV over 1 hour and bintrafusp alfa IV over 60 minutes on day 1. Treatment repeats every 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bintrafusp alfa IV over 60 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (docetaxel)Active Control1 Intervention
Patients receive docetaxel IV over 1 hour on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression may crossover to Arm I and receive bintrafusp alfa alone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp Alfa
2021
Completed Phase 2
~40
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,143 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,774 Total Patients Enrolled
Konstantinos Leventakos, M.D.Principal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to docetaxel or polysorbate 80.Your blood platelet count is at least 100,000 per cubic millimeter in the past 14 days.Your white blood cell count is at least 1500 per cubic millimeter.You had a heart attack or serious heart failure in the past 6 months and are taking medication for life-threatening heart rhythm problems.You have HIV and are not taking medication for it, or your viral load is detectable and your CD4+ count is less than 500/ml.You cannot participate if you have a brain tumor or symptoms from the spread of cancer to the brain, except under certain conditions. If you have cancer in the brain but no symptoms, you may be enrolled if you meet specific criteria. If you have been treated for cancer in the brain and meet certain criteria, you may also be enrolled.You are taking a high dose of prednisone or a similar medication by mouth.You have had serious allergic reactions to certain types of medications made from proteins.You have a history of significant bleeding events in the past month.You have a significant liver disease or a history of hepatitis B or C, except if the hepatitis B infection is resolved.You have a history of certain autoimmune diseases, but if you have hypothyroidism or type 1 diabetes that is well controlled, you may still be eligible.You have already received a specific type of immunotherapy as your first treatment for advanced cancer.You have received a specific type of treatment called anti-PD1/PD-L1 combined with platinum-based chemotherapy before.Your alkaline phosphatase level in the blood should not be more than 2.5 times the normal upper limit.You have a disease that can be measured or detected.Your kidneys are working well enough, as measured by a test called creatinine clearance, which was done within the last 14 days.You have had another type of cancer within the last 5 years, except for non-melanoma skin cancer or early cervix cancer. If you had cancer before, you should not be receiving treatment for it currently.You have not had chemotherapy within 4 weeks before joining the study.You have a history of certain lung conditions or have active lung inflammation shown on a chest CT scan.You have been diagnosed with advanced non-small cell lung cancer.Women who can have children must have a recent negative pregnancy test before joining the study.Your liver enzymes (ALT and AST) are not more than 1.5 times the upper limit of normal.Your blood clotting time is within the normal range, or if you are taking medication to prevent blood clots, your blood clotting time is within the target range for that medication.Your total bilirubin level must be within the normal range, as checked within 14 days before enrolling in the study.Your hemoglobin level should be at least 9.0 grams per deciliter.You have had moderate or severe peripheral neuropathy in the past.You have had a serious infection in the last 4 weeks that required hospitalization or was very severe.You are able to perform daily activities and self-care with little to no assistance.Patients with certain skin conditions like eczema, psoriasis, or vitiligo are allowed if their skin issues meet specific conditions, like covering less than 10% of their body and being well controlled with low potency topical steroids.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (docetaxel, bintrafusp alfa)
- Group 2: Arm II (docetaxel)
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.
Does Docetaxel have a lot of negative side effects?
"Docetaxel's safety was rated a 2 because, while there is evidence of its safety, none of the clinical data collected thus far has shown that it is an effective medication."
Answered by AI
Is there previous data on Docetaxel's effects?
"There are a total of 357 clinical trials studying Docetaxel. Out of those, 134 are in Phase 3 and currently recruiting patients. The many trials for Docetaxel tend to be based in Fuzhou, Fujian; however, there are 23348 locations running studies for this treatment globally."
Answered by AI
For what common illnesses is Docetaxel prescribed?
"Docetaxel is an effective treatment for malignant neoplasms, sarcoma, and patients that have issued advance directives."
Answered by AI
Are new participants still being enrolled in this experiment?
"Presently, this clinical trial is not recruiting patients. The most recent update to the study was on November 9th, 2022 and it was first posted on October 23rd, 2020. There are other active trials you may be eligible for: 1959 involving malignant neoplasms and 357 studies concerning Docetaxel specifically are currently looking for participants."
Answered by AI
To-date, how many individuals have opted into this research project?
"Candidates are no longer being accepted for this particular study. Although, there are currently 1959 trials actively searching for patients with malignant neoplasms and357 studies for Docetaxel that have open positions."
Answered by AI
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