Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
BioNTech SE
View at source ↗Clinical trial
Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.
Brief summary
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.
Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.
Trial details
- status
- RECRUITING
- phase
- PHASE2, PHASE3
- study type
- INTERVENTIONAL
- enrollment
- 1580
- sponsor
- BioNTech SE
- conditions
- Non-small Cell Lung Cancer
- interventions
- DRUG: Pumitamig; DRUG: Pembrolizumab; DRUG: Carboplatin; DRUG: Pemetrexed; DRUG: Paclitaxel
- start date
- 2025-01-07
- start date type
- ACTUAL
- primary completion date
- 2029-01-01
- has results
- false
- data source
- ClinicalTrials.gov
- data processed
- 2026-10-29T09:00:05
- modifications
- selected fields only; whitespace normalized; brief summary truncated to 2,000 characters
Record
- Archive ID
- nct:NCT06712316
- Published
- Dec 2, 2024
- Updated
- Oct 15, 2026
- Venue
- ClinicalTrials.gov
- ClinicalTrials.gov
- NCT06712316
- Categories
- Non-small Cell Lung Cancer
- License
- ClinicalTrials.gov terms (attribution, processing date, modifications noted)
- Provenance
- clinicaltrials