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

Conditions

• Non-small Cell Lung Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pumitamig — DRUG
  Intravenous infusion
• Pembrolizumab — DRUG
  Intravenous infusion
• Carboplatin — DRUG
  Intravenous infusion
• Pemetrexed — DRUG
  Intravenous infusion
• Paclitaxel — DRUG
  Intravenous infusion

Study Details

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.

Key Dates

Start date

Jan 7, 2025

Status verified

May 2026

Primary completion

Feb 28, 2029

Completion

Mar 31, 2030

Study Design

Enrollment

1,260 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Substudy A Phase 2 - Pumitamig Dose 1 + Carboplatin + Pemetrexed
• Experimental: Substudy A Phase 2 - Pumitamig Dose 2 + Carboplatin + Pemetrexed
• Experimental: Substudy A Phase 3 - Pumitamig + Carboplatin + Pemetrexed
  Pumitamig dose 3 for Phase 3
• Active Comparator: Substudy A Phase 3 - Pembrolizumab + Carboplatin + Pemetrexed
• Experimental: Substudy B Phase 2 - Pumitamig Dose 1 + Carboplatin + Paclitaxel
• Experimental: Substudy B Phase 2 - Pumitamig Dose 2 + Carboplatin + Paclitaxel
• Experimental: Substudy B Phase 3 - Pumitamig + Carboplatin + Paclitaxel
  Pumitamig dose 3 for Phase 3
• Active Comparator: Substudy B Phase 3 - Pembrolizumab + Carboplatin + Paclitaxel

Primary Outcome Measure

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 ]

Central Contacts

• BioNTech clinical trials patient information
  +49 6131 9084
  [email protected]

Locations (36)

Find similar trials in Anchorage, AK

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