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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 below

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My lung cancer is at Stage III and cannot be removed by surgery.

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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 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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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:

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I am currently receiving treatment for non-small cell lung cancer.

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I am HIV positive with a CD4+ count below 350 and have had AIDS-related infections.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

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

~5450

Carboplatin

2014

Completed Phase 3

~6120

Cemiplimab

2015

Completed Phase 3

~1470

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor

75 Previous Clinical Trials

114,209 Total Patients Enrolled

BioNTech Responsible PersonStudy DirectorBioNTech SE

36 Previous Clinical Trials

9,835 Total Patients Enrolled

Media Library

BNT116 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05142189 — Phase 1

$Non-Small Cell Lung Cancer Research Study Groups: Cohort 7 - BNT116 + CTLA4 antibody, Cohort 6 - BNT116 + cemiplimab + carboplatin + paclitaxel, Cohort 5 - BNT116 + cemiplimab (after concurrent chemoradiotherapy [CRT]), Cohort 1B - BNT116 monotherapy, Cohort 1A - BNT116 monotherapy, Cohort 2 - BNT116 + cemiplimab (PD-1/PD-L1 inhibitor refractory/relapsed patients), Cohort 3 - BNT116 + docetaxel, Cohort 4 - BNT116 + cemiplimab (frail patients)$