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Recruiting Phase 2/3

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

NCT06712316 · tracked via the Priya Life Science Italy tracker
Phase
Phase 2/3
Started
2025-01-07
Last updated
2026-09-22

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Pumitamig →Pembrolizumab →Carboplatin →Pemetrexed →Paclitaxel →

Pumitamig: Intravenous infusion

Pembrolizumab: Intravenous infusion

Carboplatin: Intravenous infusion

Pemetrexed: Intravenous infusion

Paclitaxel: Intravenous infusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Phase 2 - Occurrence of treatment-emergent adverse events (TEAE) (including Grade ≥3), adverse events of special interest (AESIs), treatment-related TEAEs, treatment-emergent serious adverse events (SAE), and treatment-related treatment emergent SAEs — From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit
    For substudies A and B. AEs graded according to Common Terminology Criteria for Adverse Events (CTCAE v5.0) in the combination treatment regimen.
  • Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs) — From the first dose of IMP to the 90-day Follow-Up Visit
    For substudies A and B.
  • Phase 2 - Objective response rate (ORR) — Up to approximately 2 years
    For substudies A and B. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or confirmed partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\] based on the investigator's assessment) is observed as best overall response.
  • Phase 2 - Best percentage change from baseline in tumor size — Up to approximately 2 years
    For substudies A and B. Based on investigator's tumor assessment according to RECIST v1.1.
  • Phase 3 - Progression free survival (PFS) assessed by BICR — Up to approximately 5 years
    For substudies A and B. PFS defined as the time from randomization to first documented tumor progression (progressive disease per RECIST v1.1), or death from any cause, whichever occurs first.

Trial sites (365)

FacilityCityRegionStatus
Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology Birmingham Alabama Recruiting
Alaska Oncology and Hematology, LLC Anchorage Alaska Recruiting
John Muir Clinical Research Center Concord California Recruiting
University Of California - San Diego Moores Cancer Center La Jolla California Recruiting
Vail Health Vail Colorado Recruiting
MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH) Washington D.C. District of Columbia Recruiting
MEDSTAR Washington Hospital Center (MedStar Health Research Institute) Washington D.C. District of Columbia Recruiting
Clermont Oncology Center Clermont Florida Recruiting
SSAK Partners, LLC. Coral Springs Florida Recruiting
Baptist Medical Center Jacksonville Jacksonville Florida Recruiting
Mid Florida Cancer Centers Orange City Florida Recruiting
Cleveland Clinic Florida - Martin North Hospital Stuart Florida Recruiting
H. Lee Moffit Cancer center and research institute Tampa Florida Recruiting
Cleveland Clinic Weston Hospital Weston Florida Recruiting
Northwest Georgia Oncology Centers, P.C. Marietta Georgia Recruiting
Fort Wayne Medical Oncology and Hematology, Inc. Fort Wayne Indiana Recruiting
Indiana University Health University Hospital Indianapolis Indiana Recruiting
Physicians Clinic of Iowa Cedar Rapids Iowa Recruiting
Holden Comprehensive Cancer Center, University of Iowa Hospitals and Clinics Iowa City Iowa Recruiting
Baptist Health Hardin Elizabethtown Kentucky Recruiting
Baptist Health Lexington Lexington Kentucky Recruiting
University of Kentucky Chandler Medical Center (UKCMC) - Markey Cancer Center (Lucille P. Markey Cancer Center) Lexington Kentucky Recruiting
Frederick Health Hospital- James M Stockman Cancer Institute Frederick Maryland Recruiting
Missouri Cancer Associates Columbia Missouri Recruiting
SSM Health Cancer Care - St. Clare Fenton Missouri Recruiting
Mary Lanning Healthcare (MLH) - Morrison Cancer Center (MCC) Hastings Nebraska Recruiting
Astera Cancer Care East Brunswick New Jersey Recruiting
Summit Medical Group PA Florham Park New Jersey Recruiting
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion Paramus New Jersey Recruiting
Nuvance Health Poughkeepsie New York Recruiting
Suny-Stony Brook University Cancer Center Stony Brook New York Recruiting
White Plains Hospital White Plains New York Recruiting
Fletcher Hospital, Inc. dba AdventHealth Hendersonville Hendersonville North Carolina Recruiting
Gabrail Cancer Center Research Canton Ohio Recruiting
The Christ Hospital Cancer Center Cincinnati Ohio Recruiting
University of Cincinnati Medical Center Cincinnati Ohio Recruiting
The Cleveland Clinic Cancer Center At Fairview Hospital, Moll Pavilion Cleveland Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Dayton Physicians Network Dayton Ohio Recruiting
Kettering Medical Center Kettering Ohio Recruiting

+ 325 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06712316 on ClinicalTrials.gov ↗ ← All trials in Italy