Dysautonomia International

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer

Purpose

This is a Phase 2/3, multisite, randomized, open-label study in participants with first-line non-small cell lung cancer (NSCLC). This study includes two substudies (substudy A and substudy B) that will recruit participants according to histological subtypes due to differences in chemotherapy choice for standard-of-care and type of NSCLC.

Condition

Non-small Cell Lung Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition. - Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion). - Eastern Cooperative Oncology Group Performance Status of 0 or 1. - Adequate organ function as defined in the protocol.

Exclusion Criteria

Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component. - Have received any of the following therapies or drugs within the noted time intervals prior to study treatment: - Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting. - Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody. - Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed. - Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment. - Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation. - Participants with significant risk of hemorrhage (per investigator clinical judgment). - Participants have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Substudy A Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Pemetrexed		Drug: Pumitamig Intravenous infusion Other names: BNT327 BMS-986545 PM8002 Drug: Carboplatin Intravenous infusion Drug: Pemetrexed Intravenous infusion
Experimental Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Pemetrexed		Drug: Pumitamig Intravenous infusion Other names: BNT327 BMS-986545 PM8002 Drug: Carboplatin Intravenous infusion Drug: Pemetrexed Intravenous infusion
Experimental Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + Pemetrexed		Drug: Pumitamig Intravenous infusion Other names: BNT327 BMS-986545 PM8002 Drug: Carboplatin Intravenous infusion Drug: Pemetrexed Intravenous infusion
Experimental Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Pemetrexed		Drug: Pumitamig Intravenous infusion Other names: BNT327 BMS-986545 PM8002 Drug: Carboplatin Intravenous infusion Drug: Pemetrexed Intravenous infusion
Active Comparator Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Pemetrexed		Drug: Pembrolizumab Intravenous infusion Drug: Carboplatin Intravenous infusion Drug: Pemetrexed Intravenous infusion
Experimental Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Paclitaxel		Drug: Pumitamig Intravenous infusion Other names: BNT327 BMS-986545 PM8002 Drug: Carboplatin Intravenous infusion Drug: Paclitaxel Intravenous infusion
Experimental Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Paclitaxel		Drug: Pumitamig Intravenous infusion Other names: BNT327 BMS-986545 PM8002 Drug: Carboplatin Intravenous infusion Drug: Paclitaxel Intravenous infusion
Experimental Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + Paclitaxel		Drug: Pumitamig Intravenous infusion Other names: BNT327 BMS-986545 PM8002 Drug: Carboplatin Intravenous infusion Drug: Paclitaxel Intravenous infusion
Experimental Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Paclitaxel		Drug: Pumitamig Intravenous infusion Other names: BNT327 BMS-986545 PM8002 Drug: Carboplatin Intravenous infusion Drug: Paclitaxel Intravenous infusion
Active Comparator Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Paclitaxel		Drug: Pembrolizumab Intravenous infusion Drug: Carboplatin Intravenous infusion Drug: Paclitaxel Intravenous infusion

Recruiting Locations

Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology
Birmingham, Alabama 35223

Alaska Oncology and Hematology, LLC
Anchorage, Alaska 99508

John Muir Clinical Research Center
Concord, California 94520

University Of California - San Diego Moores Cancer Center
La Jolla, California 92093

Clermont Oncology Center
Clermont, Florida 34711

Mid Florida Cancer Centers
Orange City, Florida 32763

Cleveland Clinic Florida - Martin North Hospital
Stuart, Florida 34994

H. Lee Moffit Cancer center and research institute
Tampa, Florida 33612

Cleveland Clinic Weston Hospital
Weston, Florida 33331

Fort Wayne Medical Oncology and Hematology, Inc.
Fort Wayne, Indiana 46845

Physicians Clinic of Iowa
Cedar Rapids, Iowa 52401-2112

Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242

Baptist Health Hardin
Elizabethtown, Kentucky 42701

Frederick Health Hospital- James M Stockman Cancer Institute
Frederick, Maryland 21704

Missouri Cancer Associates
Columbia, Missouri 65201

SSM Health Cancer Care - St. Clare
Fenton, Missouri 63026

Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC)
Hastings, Nebraska 68901-4470

Astera Cancer Care
East Brunswick, New Jersey 08816

Summit Medical Group PA
Florham Park, New Jersey 07932

The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
Paramus, New Jersey 07652

Suny-Stony Brook University Cancer Center
Stony Brook, New York 11794-9446

White Plains Hospital
White Plains, New York 10601

Fletcher Hospital, Inc. dba AdventHealth Hendersonville
Hendersonville, North Carolina 28792

Gabrail Cancer Center Research
Canton, Ohio 44718

The Christ Hospital Cancer Center
Cincinnati, Ohio 45219

University of Cincinnati Medical Center
Cincinnati, Ohio 45219

The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion
Cleveland, Ohio 44111

Cleveland Clinic
Cleveland, Ohio 44195-0001

Dayton Physicians Network
Dayton, Ohio 45415

Kettering Medical Center
Kettering, Ohio 45429

Cleveland Clinic - Hillcrest Hospital
Mayfield Heights, Ohio 44124

INTEGRIS Cancer Institute of Oklahoma
Oklahoma City, Oklahoma 73109

University of Tennessee Medical Center
Knoxville, Tennessee 37920

Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center
Nashville, Tennessee 37232

Virginia Cancer Specialists - Arlington
Arlington, Virginia 22201

Virginia Cancer Specialists
Fairfax, Virginia 22031

VCU Massey Cancer Center
Richmond, Virginia 23298

Shenandoah Oncology
Winchester, Virginia 22601

More Details

Status: Recruiting
Sponsor: BioNTech SE

Study Contact

BioNTech clinical trials patient information
+49 6131 9084
patients@biontech.de

Detailed Description

Each substudy contains a Phase 2 part followed by a Phase 3 part. In the Phase 2 part, participants will be randomized to one of two dose levels of pumitamig (also known as BNT327, BMS-986545, or PM8002) plus chemotherapy (Arm 1 and Arm 2). In the Phase 3 part, participants will be randomized to pumitamig plus chemotherapy (Arm 3) or pembrolizumab plus chemotherapy (Arm 4). In China, additional participants will be enrolled into the Phase 2 part of each substudy to receive pumitamig plus chemotherapy (Arm 1A) to further evaluate the selected Phase 3 dose. For the Phase 3 part of both substudies, an independent data monitoring committee (IDMC) and a blinded Independent Central Review (BICR) will be established. The IDMC will provide independent review of the data during the study as needed and the BICR will review all available tumor assessment scans for all treated participants and will confirm the progression of disease, if applicable. The planned study duration per study participant is up to 64 months.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.