Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer

This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal products and/or in combination with investigational medicinal products (IMPs) including, but not limited to, cemiplimab, docetaxel, carboplatin, paclitaxel, osimertinib, anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs), rearranged during transfection (RET) TKIs, BNT316 (an anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\] antibody), an anti-B7-H3 antibody conjugated to a topoisomerase I in

Trial Details

NCT ID
NCT05142189
Phase
PHASE1
Sponsor
BioNTech SE
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • BNT116
  • Cemiplimab
  • Docetaxel
  • Carboplatin
  • Paclitaxel
  • BNT316
Locations (sample)
  • Lexington, Kentucky, United States|37.98869,-84.47772
  • Louisville, Kentucky, United States|38.25424,-85.75941
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Houston, Texas, United States|29.76328,-95.36327
  • Fairfax, Virginia, United States|38.84622,-77.30637

Key Eligibility Criteria

  • Participants must have histologically confirmed NSCLC and measurable disease by RECIST v1.1. Note: Participants in Cohorts 1, 5 and 11 do not have …
  • Participants must present with unresectable Stage III or metastatic Stage IV NSCLC by American Joint Commission on Cancer (AJCC) Cancer Staging Man…
  • Participants in Cohorts 5 and 11 must present with unresectable Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition before receiving pre-…
  • Participants in Cohort 6 with the initial diagnosis of resectable Stage II and Stage III NSCLC by AJCC Cancer Staging Manual, Eighth Edition.

For full eligibility, visit ClinicalTrials.gov.

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