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

NCT06712316

RecruitingPhase 2, Phase 3

Sponsor: BioNTech SE

Conditions: Non-small Cell Lung Cancer

Interventions: Pumitamig, Pembrolizumab, Carboplatin, Pemetrexed, Paclitaxel

Countries: United States, Australia, Belgium, Brazil, Bulgaria, China, France, Georgia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (261)

Birmingham, Alabama, United States
Anchorage, Alaska, United States
Concord, California, United States
La Jolla, California, United States
Clermont, Florida, United States
Orange City, Florida, United States
Stuart, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
Fort Wayne, Indiana, United States
Cedar Rapids, Iowa, United States
Iowa City, Iowa, United States
Elizabethtown, Kentucky, United States
Frederick, Maryland, United States
Columbia, Missouri, United States
Fenton, Missouri, United States
Hastings, Nebraska, United States
East Brunswick, New Jersey, United States
Florham Park, New Jersey, United States
Paramus, New Jersey, United States
Stony Brook, New York, United States
White Plains, New York, United States
Hendersonville, North Carolina, United States
Canton, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Dayton, Ohio, United States
Kettering, Ohio, United States
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