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BNT116 + Standard Therapy for Non-Small Cell Lung Cancer (LuCa-MERIT-1 Trial)
Phase 1
Recruiting
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients in Cohort 5 must present with unresectable Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition before receiving pre-trial chemoradiotherapy.
Patients' NSCLC in Cohort 6 must be considered technically and medically resectable. Patients must be considered eligible for neo-adjuvant treatment.
Must not have
Ongoing active systemic treatment against NSCLC.
Known history of seropositivity for human immunodeficiency virus (HIV) with CD4+ T-cell (CD4+) counts <350 cells/µL and with a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 27 months
Awards & highlights
No Placebo-Only Group
Summary
This trialtests a new drug for advanced lung cancer, to determine its safety and best dose to use alone or with other treatments.
Who is the study for?
This trial is for adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have not responded well to certain previous treatments. Specific groups include those with unresectable Stage III or metastatic Stage IV NSCLC, and some patients must have tried a PD-1/PD-L1 inhibitor therapy. Patients should be able to tolerate additional anti-PD-1 therapy and have an acceptable performance status.
What is being tested?
The trial tests BNT116 alone and in combination with cemiplimab or docetaxel for safety, tolerability, and preliminary effectiveness. It also explores BNT116 combined with chemotherapy as neo-adjuvant treatment before surgery followed by adjuvant BNT116 + cemiplimab in resectable cases.
What are the potential side effects?
Potential side effects may include typical reactions to immunotherapy such as fatigue, skin reactions, inflammation of organs, infusion-related symptoms, possible immune system overactivity affecting various body parts, and complications from combining therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is at Stage III and cannot be removed by surgery.
Select...
My lung cancer can be surgically removed and I am eligible for treatment before surgery.
Select...
My lung cancer is at an advanced stage and cannot be surgically removed.
Select...
My lung cancer was deemed inoperable, and I've had chemoradiotherapy.
Select...
My cancer shows PD-L1 expression of 1% or more, and I will start cemiplimab at Cycle 3 in Cohort 1.
Select...
My cancer has a PD-L1 score of 50% or higher.
Select...
I can receive additional anti-PD-1 therapy without having stopped it before due to side effects.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently receiving treatment for non-small cell lung cancer.
Select...
I am HIV positive with a CD4+ count below 350 and have had AIDS-related infections.
Select...
I have had my spleen removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 27 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Cohorts 1, 2, 3, 4, and 7: Overall response rate (ORR) defined as the number of patients with complete response (CR) or partial response (PR) as best overall response (BOR)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: Cohort 7 - BNT116 + CTLA4 antibodyExperimental Treatment2 Interventions
Dose finding for the combination of BNT116 with CTLA4 antibody with dose escalation of the CTLA4 antibody
Group II: Cohort 6 - BNT116 + cemiplimab + carboplatin + paclitaxelExperimental Treatment4 Interventions
BNT116 + cemiplimab + carboplatin + paclitaxel as neo-adjuvant treatment followed by surgery, thereafter adjuvant treatment with BNT116 + cemiplimab
Group III: Cohort 5 - BNT116 + cemiplimab (after concurrent chemoradiotherapy [CRT])Experimental Treatment2 Interventions
Group IV: Cohort 4 - BNT116 + cemiplimab (frail patients)Experimental Treatment2 Interventions
Group V: Cohort 3 - BNT116 + docetaxelExperimental Treatment2 Interventions
Group VI: Cohort 2 - BNT116 + cemiplimab (PD-1/PD-L1 inhibitor refractory/relapsed patients)Experimental Treatment2 Interventions
Group VII: Cohort 1B - BNT116 monotherapyExperimental Treatment1 Intervention
Group VIII: Cohort 1A - BNT116 monotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~6550
Paclitaxel
2011
Completed Phase 4
~5370
Carboplatin
2014
Completed Phase 3
~6120
Cemiplimab
2015
Completed Phase 3
~1470
Find a Location
Who is running the clinical trial?
BioNTech SELead Sponsor
71 Previous Clinical Trials
110,999 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
36 Previous Clinical Trials
9,828 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have NSCLC with PD-L1 expression ≥1% and cannot have chemotherapy as my first treatment.You have been on strong medications that weaken your immune system in the last 3 months before the trial.My lung cancer is at Stage III and cannot be removed by surgery.I have been treated with both a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.I am on low-dose steroids or only take them as hormone replacement.My lung cancer can be surgically removed and I am eligible for treatment before surgery.I am currently receiving treatment for non-small cell lung cancer.My lung cancer is confirmed by lab tests and can be measured.I have an autoimmune disease but it's controlled or is one of the exceptions listed.I have stable brain or spinal cancer and don't need steroids for it.I am HIV positive with a CD4+ count below 350 and have had AIDS-related infections.I am in good physical condition and can care for myself.My cancer has a specific mutation, but I can't receive the usual targeted therapy for it.My lung cancer is at an advanced stage and cannot be surgically removed.My lung cancer was deemed inoperable, and I've had chemoradiotherapy.My cancer shows PD-L1 expression of 1% or more, and I will start cemiplimab at Cycle 3 in Cohort 1.My cancer has a PD-L1 score of 50% or higher.My NSCLC worsened on PD-1/PD-L1 therapy or within 6 months after stopping it.My lung cancer was initially diagnosed as Stage II or III and considered operable.I can receive additional anti-PD-1 therapy without having stopped it before due to side effects.I have had treatments including PD-1/PD-L1 inhibitors, platinum-based chemotherapy, and another systemic therapy.I have had my spleen removed.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 7 - BNT116 + CTLA4 antibody
- Group 2: Cohort 6 - BNT116 + cemiplimab + carboplatin + paclitaxel
- Group 3: Cohort 5 - BNT116 + cemiplimab (after concurrent chemoradiotherapy [CRT])
- Group 4: Cohort 1B - BNT116 monotherapy
- Group 5: Cohort 1A - BNT116 monotherapy
- Group 6: Cohort 2 - BNT116 + cemiplimab (PD-1/PD-L1 inhibitor refractory/relapsed patients)
- Group 7: Cohort 3 - BNT116 + docetaxel
- Group 8: Cohort 4 - BNT116 + cemiplimab (frail patients)
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.
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