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

RecruitingPhase 2/3

A Phase II/III, Multisite, Randomized Master Protocol for a Global Trial of BNT327 in Combination With Chemotherapy and Other Investigational Agents in First-line Non-small Cell Lung Cancer

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Key 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.

Key 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.

About the study

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.

What is being tested

Sponsor: BioNTech SE · Participants: 1,580 · Started: Jan 7, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06712316

Locations in the U.S.

AlabamaBirmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology, Birmingham
AlaskaAlaska Oncology and Hematology, LLC, Anchorage
CaliforniaJohn Muir Clinical Research Center, Concord
University Of California - San Diego Moores Cancer Center, La Jolla
ColoradoVail Health, Vail
District of ColumbiaMEDSTAR Washington Hospital Center (MedStar Health Research Institute), Washington D.C.
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH), Washington D.C.
FloridaClermont Oncology Center, Clermont
SSAK Partners, LLC., Coral Springs
Baptist Medical Center Jacksonville, Jacksonville
Mid Florida Cancer Centers, Orange City
Cleveland Clinic Florida - Martin North Hospital, Stuart
H. Lee Moffit Cancer center and research institute, Tampa
Cleveland Clinic Weston Hospital, Weston
GeorgiaNorthwest Georgia Oncology Centers, P.C., Marietta
IndianaFort Wayne Medical Oncology and Hematology, Inc., Fort Wayne
Indiana University Health University Hospital, Indianapolis
IowaPhysicians Clinic of Iowa, Cedar Rapids
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics, Iowa City
KentuckyBaptist Health Hardin, Elizabethtown
Baptist Health Lexington, Lexington
University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center), Lexington
MarylandFrederick Health Hospital- James M Stockman Cancer Institute, Frederick
MissouriMissouri Cancer Associates, Columbia
SSM Health Cancer Care - St. Clare, Fenton
NebraskaMary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC), Hastings
New JerseyAstera Cancer Care, East Brunswick
Summit Medical Group PA, Florham Park
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion, Paramus
New YorkNuvance Health, Poughkeepsie
Suny-Stony Brook University Cancer Center, Stony Brook
White Plains Hospital, White Plains
North CarolinaFletcher Hospital, Inc. dba AdventHealth Hendersonville, Hendersonville
OhioGabrail Cancer Center Research, Canton
The Christ Hospital Cancer Center, Cincinnati
University of Cincinnati Medical Center, Cincinnati
Cleveland Clinic, Cleveland
The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion, Cleveland
Dayton Physicians Network, Dayton
Kettering Medical Center, Kettering
Cleveland Clinic - Hillcrest Hospital, Mayfield Heights
OklahomaINTEGRIS Cancer Institute of Oklahoma, Oklahoma City
TennesseeUniversity of Tennessee Medical Center, Knoxville
Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville
UtahUtah Cancer Specialists, Salt Lake City
VirginiaVirginia Cancer Specialists - Arlington, Arlington
Virginia Cancer Specialists, Fairfax
VCU Massey Cancer Center, Richmond
Shenandoah Oncology, Winchester
West VirginiaWest Virginia University Hospitals - Mary Babb Randolph Cancer Center, Morgantown
WisconsinGundersen Lutheran Medical Center, La Crosse

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.