Clinical trial · no report yet · Phase 2/Phase 3
ROSETTA Lung-02
Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)
- NCT06712316 ↗
- Recruiting
- BioNTech SE
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 4 |
The trial
ClinicalTrials.gov- 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
- Phase
- Phase 2/Phase 3
- Status
- Recruiting
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Pumitamig; Pembrolizumab; Carboplatin; Pemetrexed; Paclitaxel
- Arms
- Substudy A Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Pemetrexed · Experimental
- Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Pemetrexed · Experimental
- Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + Pemetrexed · Experimental
- Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Pemetrexed · Experimental
- Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Pemetrexed · Active comparator
- Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Paclitaxel · Experimental
- Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Paclitaxel · Experimental
- Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + Paclitaxel · Experimental
- Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Paclitaxel · Experimental
- Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Paclitaxel · Active comparator
- Enrollment
- 1,580 (estimated)
- 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
- Phase 3 - Progression free survival (PFS) assessed by BICR
- Sponsor
- BioNTech SE with Bristol-Myers Squibb
- Start
- Jan 7, 2025
- Primary completion
- Jan 2029 (estimated)
- Results posted
- No
- Registry record
- NCT06712316 · updated Oct 15, 2026