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Checkpoint Inhibitor
BNT411 + Chemotherapy for Small Cell Lung Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system) who received no prior chemotherapy for extensive stage disease.
For Part 1A: Histologically confirmed solid tumor that is metastatic or unresectable with no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that uses a protein to help the immune system kill cancer cells.
Who is the study for?
This trial is for adults with ES-SCLC who haven't had chemo for it yet, or those with solid tumors without standard treatment options. Participants must be over 18, have a certain level of physical fitness (ECOG 0-1), and not have specific health issues like interstitial lung disease. They should also agree to use birth control if necessary and provide tissue samples.Check my eligibility
What is being tested?
The trial tests BNT411 alone and combined with Atezolizumab, Carboplatin, and Etoposide in cancer patients. It's the first time this drug—a TLR7 agonist expected to boost immune responses—is being used in humans to find a safe dosage.See study design
What are the potential side effects?
Potential side effects include typical reactions from immune therapies such as inflammation in various organs, infusion-related symptoms, fatigue, digestive problems, blood disorders, increased risk of infections and possibly others related to the novel nature of BNT411.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My small cell lung cancer is in the extensive stage and I haven't had chemotherapy for it.
Select...
My cancer has spread, can't be surgically removed, and I can't be treated with standard therapies.
Select...
I do not have lung diseases like interstitial lung disease or pneumonitis.
Select...
My cancer is advanced, cannot be surgically removed, and has no standard treatment options.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 and 2: Incidence of IMP treatment discontinuations due to toxicity
Part 1 and 2: Incidence of TEAEs
Part 1 and 2: Incidence of dose-limiting toxicities (DLTs)
+3 moreSecondary outcome measures
Part 1 and 2: PK assessments: Area under the concentration time curve (AUC)
Part 1 and 2: PK assessments: Clearance (CL)
Part 1 and 2: PK assessments: Maximum Plasma Concentration (Cmax)
+7 moreOther outcome measures
Part 2 only: Overall Survival (OS) time
Part 2 only: Progression Free Survival (PFS) time
Part 2 only: immune Disease Control Rate (iDCR)
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Part 2 - expansion cohortsExperimental Treatment4 Interventions
BNT411 either as monotherapy or in combination with with atezolizumab, carboplatin, and etoposide
Group II: Part 1B - combination dose escalationExperimental Treatment4 Interventions
BNT411 in combination with atezolizumab, carboplatin, and etoposide
Group III: Part 1A - monotherapy dose escalationExperimental Treatment1 Intervention
BNT411 monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Etoposide
2010
Completed Phase 3
~2440
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
BioNTech SELead Sponsor
64 Previous Clinical Trials
109,126 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
33 Previous Clinical Trials
9,701 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a history of seizures, stroke, fluid drainage needs, eye issues, recent fever, or autoimmune diseases.I am 18 years old or older.I can provide a sample of my tumor preserved in paraffin.This applies to both Part 1A and Part 1B of the study.I have not had major surgery in the last 4 weeks.Your disease can be measured using a specific method called RECIST 1.1.My blood, liver, and kidney functions are all within normal ranges.My side effects from previous treatments are mild.I am a man who can father a child and will use protection during sex.I can attend all required trial visits.My small cell lung cancer is in the extensive stage and I haven't had chemotherapy for it.I am not allergic or unable to take atezolizumab, carboplatin, or etoposide.I have extensive-stage small cell lung cancer with no prior chemo for this stage and no lung conditions.I am currently being treated for hepatitis B or have an active hepatitis C infection.Women who could become pregnant must have a negative pregnancy test at screening.I have another cancer that has not been in remission for 2 years.You are allergic to BNT411 or similar drugs.Your albumin level is 30 g/L or higher during screening.I am HIV positive with low CD4+ counts and have had AIDS-related infections.I haven't had chemo or radiotherapy for small-cell lung cancer in the last 6 months.My cancer has spread, can't be surgically removed, and I can't be treated with standard therapies.I do not have lung diseases like interstitial lung disease or pneumonitis.My cancer is advanced, cannot be surgically removed, and has no standard treatment options.I have an infection treated with IV drugs less than 2 weeks ago.I have been treated with a TLR7 agonist before.I am taking more than 10 mg of prednisone or its equivalent daily for another health issue.I am fully active or can carry out light work.You have recently developed new or growing tumors in your brain or spinal cord.I am not taking strong drugs that affect liver enzymes.You have abnormal heart test results that are important for your health.I have been following my treatment plan within the given timelines.
Research Study Groups:
This trial has the following groups:- Group 1: Part 2 - expansion cohorts
- Group 2: Part 1A - monotherapy dose escalation
- Group 3: Part 1B - combination dose escalation
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.
What primary conditions is BNT411 prescribed to treat?
"BNT411 is a viable therapy for recurrent, advanced directives, and advanced cervical cancer."
Answered by AI
Are participants currently being enrolled in this trial?
"According to information found on clinicaltrials.gov, enrollment is ongoing for this medical trial which was initially posted June 19th 2020 and last revised November 30th 2022."
Answered by AI
How many participants are actively taking part in this clinical research?
"This medical trial calls for 60 qualified individuals to partake. Potential participants can find a participating centre in either Chicago, Illinois or Los Angeles, California; Northwestern Medical Faculty Foundation and Cedars-Sinai Medical Center respectively."
Answered by AI
What precedent has been established with regards to BNT411 research?
"Currently, 1175 investigations into BNT411 are underway. 318 of these experiments have reached Phase 3 status and span 68,059 different sites across the world, with a concentration in Shanghai."
Answered by AI
Who else is applying?
What state do they live in?
South Carolina
How old are they?
65+
What site did they apply to?
Cedars-Sinai Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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