Vanderbilt Clinical Trials

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.

Exclusion Criteria

Have histologically or cytologically confirmed NSCLC with small-cell lung cancer histologic or neuroendocrine 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 neo-adjuvant/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). - Have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria may 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 - Pumitamig Dose 1 + Carboplatin + Pemetrexed		Drug: Pumitamig Intravenous infusion Other names: BNT327 Drug: Carboplatin Intravenous infusion Drug: Pemetrexed Intravenous infusion
Experimental Substudy A Phase 2 - Pumitamig Dose 2 + Carboplatin + Pemetrexed		Drug: Pumitamig Intravenous infusion Other names: BNT327 Drug: Carboplatin Intravenous infusion Drug: Pemetrexed Intravenous infusion
Experimental Substudy A Phase 3 - Pumitamig + Carboplatin + Pemetrexed	Pumitamig dose 3 for Phase 3	Drug: Pumitamig Intravenous infusion Other names: BNT327 Drug: Carboplatin Intravenous infusion Drug: Pemetrexed Intravenous infusion
Active Comparator Substudy A Phase 3 - Pembrolizumab + Carboplatin + Pemetrexed		Drug: Pembrolizumab Intravenous infusion Drug: Carboplatin Intravenous infusion Drug: Pemetrexed Intravenous infusion
Experimental Substudy B Phase 2 - Pumitamig Dose 1 + Carboplatin + Paclitaxel		Drug: Pumitamig Intravenous infusion Other names: BNT327 Drug: Carboplatin Intravenous infusion Drug: Paclitaxel Intravenous infusion
Experimental Substudy B Phase 2 - Pumitamig Dose 2 + Carboplatin + Paclitaxel		Drug: Pumitamig Intravenous infusion Other names: BNT327 Drug: Carboplatin Intravenous infusion Drug: Paclitaxel Intravenous infusion
Experimental Substudy B Phase 3 - Pumitamig + Carboplatin + Paclitaxel	Pumitamig dose 3 for Phase 3	Drug: Pumitamig Intravenous infusion Other names: BNT327 Drug: Carboplatin Intravenous infusion Drug: Paclitaxel Intravenous infusion
Active Comparator Substudy B Phase 3 - Pembrolizumab + Carboplatin + Paclitaxel		Drug: Pembrolizumab Intravenous infusion Drug: Carboplatin Intravenous infusion Drug: Paclitaxel Intravenous infusion

Recruiting Locations

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

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. Participants will be randomized to one of two dose levels of pumitamig (BNT327) plus chemotherapy for the Phase 2 part of each substudy. 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. 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.