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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' prior therapy in Cohort 1 must have included at least a PD-1/PD-L1 inhibitor and a platinum-based chemotherapy regimen as well as one other line of systemic therapy (except if a patient is not candidate for a platinum-based chemotherapy and/or PD-1/PD-L1 inhibitor and/or another line of systemic therapy).
Patients in Cohort 4 who are not candidates for chemotherapy as first-line treatment for the advanced or metastasized stage of NSCLC may be enrolled if presenting with PD-L1 expression: TPS ≥1% in tumor cells (as determined locally).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 48 months
Awards & highlights

LuCa-MERIT-1 Trial 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.Check my eligibility
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.See study design
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.

LuCa-MERIT-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had treatments including PD-1/PD-L1 inhibitors, platinum-based chemotherapy, and another systemic therapy.
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I have NSCLC with PD-L1 expression ≥1% and cannot have chemotherapy as my first treatment.
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My lung cancer is at Stage III and cannot be removed by surgery.
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I have been treated with both a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.
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My lung cancer can be surgically removed and I am eligible for treatment before surgery.
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My lung cancer is confirmed by lab tests and can be measured.
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I am in good physical condition and can care for myself.
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My lung cancer is at an advanced stage and cannot be surgically removed.
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My lung cancer was deemed inoperable, and I've had chemoradiotherapy.
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My cancer shows PD-L1 expression of 1% or more, and I will start cemiplimab at Cycle 3 in Cohort 1.
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My cancer has a PD-L1 score of 50% or higher.
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My NSCLC worsened on PD-1/PD-L1 therapy or within 6 months after stopping it.
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My lung cancer was initially diagnosed as Stage II or III and considered operable.
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I can receive additional anti-PD-1 therapy without having stopped it before due to side effects.

LuCa-MERIT-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 6 only: Occurrence of post-surgical adverse events (AEs) related to BNT116 and cemiplimab
Cohort 6 only: Occurrence of treatment-related delays to surgery more than 9 weeks post the last dose of neo-adjuvant treatment
Cohorts 1 to 6: Occurrence of treatment-emergent adverse events (TEAEs) reported by relationship, seriousness, and grade according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
+1 more
Secondary outcome measures
All cohorts: Overall survival (OS) defined as the time of first trial treatment until death from any cause
Cohort 5 and 6: EFS rate at 12 and 24 months defined as the number of patients without an EFS-defining event divided by the number of patients in the efficacy analysis set.
Cohort 5 and 6: Event free survival (EFS) defined as the length of time from first trial treatment to any of the following events: progression of disease, recurrence of disease or death from any cause, whichever occurs first.
+8 more

LuCa-MERIT-1 Trial Design

7Treatment groups
Experimental Treatment
Group I: 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 II: Cohort 5 - BNT116 + cemiplimab (after concurrent chemoradiotherapy [CRT])Experimental Treatment2 Interventions
Group III: Cohort 4 - BNT116 + cemiplimab (frail patients)Experimental Treatment2 Interventions
Group IV: Cohort 3 - BNT116 + docetaxelExperimental Treatment2 Interventions
Group V: Cohort 2 - BNT116 + cemiplimab (PD-1/PD-L1 inhibitor refractory/relapsed patients)Experimental Treatment2 Interventions
Group VI: Cohort 1B - BNT116 monotherapyExperimental Treatment1 Intervention
Group VII: Cohort 1A - BNT116 monotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Cemiplimab
2015
Completed Phase 3
~1340

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
63 Previous Clinical Trials
107,923 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
32 Previous Clinical Trials
8,528 Total Patients Enrolled

Media Library

BNT116 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05142189 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Cohort 1A - BNT116 monotherapy, Cohort 1B - BNT116 monotherapy, Cohort 5 - BNT116 + cemiplimab (after concurrent chemoradiotherapy [CRT]), Cohort 6 - BNT116 + cemiplimab + carboplatin + paclitaxel, Cohort 2 - BNT116 + cemiplimab (PD-1/PD-L1 inhibitor refractory/relapsed patients), Cohort 3 - BNT116 + docetaxel, Cohort 4 - BNT116 + cemiplimab (frail patients)
Non-Small Cell Lung Cancer Clinical Trial 2023: BNT116 Highlights & Side Effects. Trial Name: NCT05142189 — Phase 1
BNT116 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05142189 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being recruited for this experiment?

"According to the clinicaltrials.gov database, this medical trial is still actively searching for participants since it was initially posted on June 17th 2022 and recently updated on November 10th 2022."

Answered by AI

What experiments have been previously undertaken to research the efficacy of combining Cohort 2 - BNT116 and cemiplimab?

"At present, Cohort 2 - BNT116 + cemiplimab has 374 live studies with 130 of them at Phase 3. While most are based in São Paulo and Rio Grande Do Norte respectively, there is a total 24109 sites conducting trials for the cohort around the world."

Answered by AI

What is the maximum capacity of this research endeavor?

"Affirmative. According to clinicaltrials.gov, this study has been recruiting since June 17th 2022 and is actively searching for 80 individuals from 2 different healthcare facilities as of November 10th 2022."

Answered by AI

Has the combination of BNT116 and cemiplimab obtained FDA clearance?

"Our team has rated Cohort 2 - BNT116 + cemiplimab with a score of 1 due to limited clinical data available that supports its safety and efficacy."

Answered by AI

What is the traditional purpose of combining Cohort 2 - BNT116 and cemiplimab?

"Cohort 2 - BNT116 + cemiplimab is employed to treat metastatic cutaneous squamous cell carcinoma, but can also be beneficial for patients with head and soft tissue sarcoma (STS) or a ROS1 gene mutation."

Answered by AI
~65 spots leftby Jan 2026