Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Docetaxel

Vaccines

Albumin-Bound Paclitaxel

Cemiplimab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

BNT116 + cemiplimab + carboplatin + paclitaxel as neo-adjuvant treatment followed by surgery, thereafter adjuvant treatment with BNT116 + cemiplimab

BNT116

BioNTech clinical trials patient information

BioNTech Responsible Person

This First-in-human (FIH) trial for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with cemiplimab or docetaxel in patients with advanced or metastasized non-small cell lung cancer (NSCLC) and unresectable NSCLC after chemoradiotherapy (CRT). Furthermore, the trial aims to establish the safety and feasibility of BNT116 in combination with cemiplimab and chemotherapy (carboplatin+paclitaxel) as neo-adjuvant treatment in resectable NSCLC followed by surgery and adjuvant BNT116 + cemiplimab. The trial will comprise several cohorts for dose confirmation in monotherapy as well as in combinations of BNT116 as mentioned above.

Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

LuCa-MERIT-1: First-in-human, Open Label, Phase I Dose Confirmation Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

according to response evaluation criteria in solid tumors (RECIST) v1.1 divided by the number of patients in the efficacy analysis set

BioNTech SE

Symptoms and General Pathology

Death

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Arm A: Cemiplimab is administered by IV infusion Q3W

Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.

Cemiplimab is administered Q3W by IV infusion

Clinical Trials Administrator

Clinical Trial Management

This study is researching an investigational drug, called BNT116, in combination with cemiplimab. BNT116 and cemiplimab will each be called a "study drug", and together be called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC).

The aims of this study are to see how safe and tolerable BNT116 is in combination with cemiplimab and to see how effective BNT116 in combination with cemiplimab is compared to cemiplimab by itself at treating cancer.

The study is looking at several other research questions, including:

* What side effects may happen from receiving the study drugs
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects)

A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)

A Phase 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination With BNT116 (FixVac Lung) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)

Proportion of patients with a best overall response of confirmed CR or PR

The time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR

The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier

The time from enrollment to the date of death due to any cause

A TEAE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.

An SAE is any untoward medical occurrence that at any dose:

* Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger)
* Is life-threatening
* Requires in-patient hospitalization or prolongation of existing hospitalization
* Results in persistent or significant disability/incapacity
* Is a congenital anomaly/birth defect
* Is an important medical event

According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Causality grading system (≥ Grade 3 or higher)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer	NCT05142189	Non-Small Cell ...	BNT116 Cemiplimab Docetaxel Carboplatin Paclitaxel	18 Years -	BioNTech SE
A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)	NCT05557591	Advanced Non-Sm...	BNT116 Cemiplimab	18 Years -	Regeneron Pharmaceuticals
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer	NCT05142189	Non-Small Cell ...	BNT116 Cemiplimab Docetaxel Carboplatin Paclitaxel	18 Years -	BioNTech SE

Spots Global Cancer Trial Database for bnt116

Every month we try and update this database with for bnt116 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bnt116

Every month we try and update this database with for bnt116 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bnt116 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.