Recruiting NCT06712316

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

Phase II / Phase III Interventional Non-small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Pumitamig, Pembrolizumab, Carboplatin, Pemetrexed.
Who it may be relevant to: Registry conditions: Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Belgium, Brazil, Bulgaria +15
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

Drug Pumitamig
Intravenous infusion
Drug Pembrolizumab
Intravenous infusion
Drug Carboplatin
Intravenous infusion
Drug Pemetrexed
Intravenous infusion
Drug Paclitaxel
Intravenous infusion

Primary outcome measures

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 [Time frame: From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit]
Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs) [Time frame: From the first dose of IMP to the 90-day Follow-Up Visit]
Phase 2 - Objective response rate (ORR) [Time frame: Up to approximately 2 years]
Phase 2 - Best percentage change from baseline in tumor size [Time frame: Up to approximately 2 years]
Phase 3 - Progression free survival (PFS) assessed by blinded independent central review (BICR) [Time frame: Up to approximately 5 years]

Secondary outcome measures (12)

Phase 3 - Overall survival (OS) [Time frame: Up to approximately 5 years]
Phase 2 - Duration of Response (DOR) [Time frame: Up to approximately 2 years]
Phase 2 - Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
Phase 3 - PFS assessed by investigator [Time frame: Up to approximately 5 years]
Phase 3 - ORR [Time frame: Up to approximately 2 years]
Phase 3 - PFS rate as assessed by BICR [Time frame: At 6, 12, and 18 months]
Phase 3 - PFS rate as assessed by investigator [Time frame: At 6, 12, and 18 months]
Phase 3 - OS rate [Time frame: At 6, 12, 18, 24 months]
Phase 3 - Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life-score 30 Questionnaire (QLQ-C30) global health status/Quality-of-Life (QoL) score (Items 29 and 30) [Time frame: Up to approximately 5 years]
Phase 3 - Change from baseline in EORTC QLQ-C30 physical functioning [Time frame: Up to approximately 5 years]
Phase 3 - Change from baseline in coughing scale of the EORTC lung cancer-specific quality-of-life questionnaire (QLQ-LC29) [Time frame: Up to approximately 5 years]
Phase 3 - Change from baseline in shortness of breath scale of the EORTC QLQ-LC29 [Time frame: Up to approximately 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Sequential
Masking: Open label
Primary purpose: Treatment