{"preliminary_commentary":{"by_channel":{"x_thread":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"ROSETTA Lung-02","nct_id":"NCT06712316","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=rosetta-lung-02-nct06712316. The price is an estimate of verified HCP statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified HCP statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":null,"label":"Substudy A Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Pemetrexed","type":"EXPERIMENTAL"},{"description":null,"label":"Substudy A Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Pemetrexed","type":"EXPERIMENTAL"},{"description":null,"label":"Substudy A Phase 2 (Arm 1A - China only) - Pumitamig Dose 3 + Carboplatin + Pemetrexed","type":"EXPERIMENTAL"},{"description":null,"label":"Substudy A Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Pemetrexed","type":"EXPERIMENTAL"},{"description":null,"label":"Substudy A Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Pemetrexed","type":"ACTIVE_COMPARATOR"},{"description":null,"label":"Substudy B Phase 2 (Arm 1) - Pumitamig Dose 1 + Carboplatin + Paclitaxel","type":"EXPERIMENTAL"},{"description":null,"label":"Substudy B Phase 2 (Arm 2) - Pumitamig Dose 2 + Carboplatin + Paclitaxel","type":"EXPERIMENTAL"},{"description":null,"label":"Substudy B Phase 2 (Arm 1A, China only) - Pumitamig Dose 3 + Carboplatin + Paclitaxel","type":"EXPERIMENTAL"},{"description":null,"label":"Substudy B Phase 3 (Arm 3) - Pumitamig Dose 3 + Carboplatin + Paclitaxel","type":"EXPERIMENTAL"},{"description":null,"label":"Substudy B Phase 3 (Arm 4) - Pembrolizumab + Carboplatin + Paclitaxel","type":"ACTIVE_COMPARATOR"}],"collaborators":["Bristol-Myers Squibb"],"completion_date":{"date":"2031-12","type":"ESTIMATED"},"conditions":["Non-small Cell Lung Cancer"],"enrollment":{"count":1580,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Pumitamig","otherNames":["BNT327","BMS-986545","PM8002"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":[],"type":"DRUG"},{"name":"Carboplatin","otherNames":[],"type":"DRUG"},{"name":"Pemetrexed","otherNames":[],"type":"DRUG"},{"name":"Paclitaxel","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-15","lead_sponsor":"BioNTech SE","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","overall_status":"RECRUITING","phases":["PHASE2","PHASE3"],"primary_completion_date":{"date":"2029-01","type":"ESTIMATED"},"primary_outcomes":[{"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","timeFrame":"From the first dose of the investigational medicinal product (IMP) to the 90-day Follow-Up Visit"},{"measure":"Phase 2 - Occurrence of dose interruption, reduction, and discontinuation of IMP due to TEAEs (including related TEAEs)","timeFrame":"From the first dose of IMP to the 90-day Follow-Up Visit"},{"measure":"Phase 2 - Objective response rate (ORR)","timeFrame":"Up to approximately 2 years"},{"measure":"Phase 2 - Best percentage change from baseline in tumor size","timeFrame":"Up to approximately 2 years"},{"measure":"Phase 3 - Progression free survival (PFS) assessed by BICR","timeFrame":"Up to approximately 5 years"}],"references":[],"start_date":{"date":"2025-01-07","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Safety, Efficacy, and Pharmacokinetics of BNT327 in Combination With Chemotherapy and Other Investigational Agents for Lung Cancer (ROSETTA Lung-02)","url":"https://clinicaltrials.gov/study/NCT06712316"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/rosetta-lung-02-nct06712316"}