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The Dareon™-5 Trial

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A clinical trial for patients with relapsed/refractory small-cell lung cancer or other relapsed/refractory neuroendocrine carcinomas

The DareonTM-5 trial is now enrolling patients who have relapsed/refractory small-cell lung cancer (SCLC) or relapsed/refractory neuroendocrine carcinomas (NECs). This is a phase 2, open label, dose-selection study of the investigational DLL3/CD3 T-cell engager, BI 764532.

Patients may be eligible to participate if they:

  • Are 18 years of age or older
  • Have relapsed/refractory SCLC, after ≥2 prior lines of therapy including at least one platinum-based regimen, or have relapsed/refractory extra-pulmonary NECs (excluding Merkel cell carcinoma, medullary thyroid cancer, and neuroendocrine prostate cancer) or large cell NEC of the lung, after ≥1 prior line of therapy including at least one platinum-based regimen
  • Have at least one measurable lesion within 21 days prior to the first dose of BI 764532
  • Meet additional criteria

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Study information available in clinicaltrials.gov: NCT05882058

Pipeline compound(s) are under pre-clinical and/or clinical investigation and have not been approved by regulatory authorities for commercial use in patients. Efficacy and safety have not been established and there is no guarantee that they will become commercially available for the use(s) under investigation.