Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer

This is a Phase III, multisite, randomized, double-blinded study to investigate pumitamig (BNT327) combined with chemotherapy (etoposide/carboplatin) compared to atezolizumab combined with chemotherapy (etoposide/carboplatin) for the treatment of participants with previously untreated extensive-stage small-cell lung cancer (ES-SCLC).

Trial Details

NCT ID
NCT06712355
Phase
PHASE3
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Pumitamig
  • Atezolizumab
  • Etoposide
  • Carboplatin (or cisplatin if carboplatin is not tolerated)
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Clermont, Florida, United States|28.54944,-81.77285
  • Niles, Illinois, United States|42.01892,-87.80284
  • Fort Wayne, Indiana, United States|41.1306,-85.12886
  • Ames, Iowa, United States|42.03471,-93.61994

Key Eligibility Criteria

  • Have histologically or cytologically confirmed ES-SCLC (using the AJCC \[American Joint Committee on Cancer\] tumor node metastasis staging system …
  • Have not had prior systemic therapy for ES-SCLC. However, participants with prior chemoradiotherapy for limited-stage-SCLC must have been treated w…
  • Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablatio…
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

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