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NCT06712316Recruiting

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

Official recordSimplified version

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.

Inclusion criteria

• Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition. • Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion). • Eastern Cooperative Oncology Group Performance Status of 0 or 1. • Adequate organ function as defined in the protocol.

Exclusion criteria

• Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component. • Have received any of the following therapies or drugs within the noted time intervals prior to study treatment: • Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting. • Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody. • Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed. • Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment. • Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation. • Participants with significant risk of hemorrhage (per investigator clinical judgment). • Participants have superior vena cava syndrome or symptoms of spinal cord compression. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 2 · Phase 3
Study type
Interventional
Countries
Switzerland, France, Germany, Italy, United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Chile, China, Georgia, Hungary, Japan, Poland, Romania, South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom
Sponsor
BioNTech SE(Industry)
Protocol no.
BNT327-06
Conditions
Non-small Cell Lung Cancer
Interventions
Drug

Treatments studied

  • Pumitamig
  • Pembrolizumab
  • Carboplatin
  • Pemetrexed
  • Paclitaxel

Collaborators

Bristol-Myers Squibb

Locations · 359

  • Baden, SwitzerlandKantonspital BadenRecruiting at this site
  • Lausanne, SwitzerlandCentre Hospitalier Universitaire Vaudois Lausanne (CHUV) - Centre de transplantation d'organes (CTO)Recruiting at this site
  • Münsterlingen, SwitzerlandKantonsspital MünsterlingenRecruiting at this site
  • Angers, FranceInstitut de Cancerologie de l'Ouest Paul PapinRecruiting at this site
  • Angers, FranceCentre Hospitalier Universitaire d'Angers (CHU Angers)Recruiting at this site
  • Bayonne, FranceCentre Hospitalier de la Cote BasqueRecruiting at this site
  • Bordeaux, FranceCentre Hospitalier Universitaire de Bordeaux - Hopital Saint - AndreRecruiting at this site
  • Bordeaux, FranceInstitut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud OuestRecruiting at this site
  • Bron, FranceHospices Civils de Lyon - Hopital Louis PradelRecruiting at this site
  • Caen, FranceCHU Caen NormandieRecruiting at this site
  • Caen, FranceCentre Francois BaclesseRecruiting at this site
  • Clermont-Ferrand, FranceCentre Hospitalier Universitaire de Clermont Ferrand - Gabriel MontpiedRecruiting at this site
  • Créteil, FranceCentre Hospitalier Intercommunal de Creteil (CHIC) - Centre de ressources et de competences pour la mucoviscidose (C.R.C.M.)Recruiting at this site
  • La Tronche, FranceCentre Hospitalier Universitaire De Grenoble- Hopital Albert MichallonRecruiting at this site
  • Limoges, FranceCentre Hospitalier Universitaire (CHU) De Limoges Hopital DupuytrenRecruiting at this site
  • Lyon, FranceHospices Civils de Lyon (HCL) - Hopital de la Croix-RousseRecruiting at this site
  • Marseille, FranceInstitut Paoli-CalmettesRecruiting at this site
  • Mulhouse, FranceGHRMSA Hopital Emile MullerRecruiting at this site
  • Paris, FranceInstitut Curie - Centre de RechercheRecruiting at this site
  • Paris, FranceGroupe Hospitalier Pitie-SalpetriereRecruiting at this site
  • Paris, FranceCIC Cochin Pasteur, Hopital CochinRecruiting at this site
  • Pierre-Bénite, FranceHopital Lyon SudRecruiting at this site
  • Rennes, FranceCHU de Rennes, Hopital de PontchaillouRecruiting at this site
  • Saint-Herblain, FranceInstitut de Cancerologie de l'Ouest (ICO)- CRLCC Rene GauducheauRecruiting at this site
  • Strasbourg, FranceCentre Regional Lutte Contre Le Cancer Paul StraussRecruiting at this site
  • Suresnes, FranceHopital FochRecruiting at this site
  • Toulon, FranceCentre Hospitalier Intercommunal Toulon La Seyne Sur Mer (C.H.I.T.S) - Hospital Font-PreRecruiting at this site
  • Villejuif, FranceInstitut Gustave Roussy-Gustave Roussy Cancer Center -DITEPRecruiting at this site
  • Aachen, GermanyUniklinik RWTH Aachen Medizinische Klinik IVRecruiting at this site
  • Berlin, GermanyEvangelische Lungenklinik BerlinRecruiting at this site

In total, worldwide, 359 of the 365 sites listed in the registry are recruiting; the other 6 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 15, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 329 more locations

Other identifiers

  • 2024-515764-31-00 · CTIS number

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.