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Phase 2/3Recruiting

Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)

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

Sponsor
BioNTech SE (Industry)
Enrolment
1,580 planned
Conditions
Non-small Cell Lung Cancer
Interventions
Pumitamig; Pembrolizumab; Carboplatin; Pemetrexed; Paclitaxel
Ages
adults, older adults
Registry
NCT06712316, CTIS2024-515764-31-00

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • 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
  • Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)
  • Phase 2 - Objective response rate (ORR)
  • Phase 2 - Best percentage change from baseline in tumor size

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered