About this trial
A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.
Eligibility criteria
Qualifiers
Have confirmed locally advanced or metastatic NSCLC
Thyroid-stimulating hormone (TSH) within normal limits
Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
Disqualifiers
Cohort A only: Participants with Grade 3 or higher toxic effects to manage adverse events from previous treatment with immunotherapy
Cohort B only: Prior therapy with an immune checkpoint inhibitor.
Have known EGFR or ALK mutations
Have had prior treatment with recombinant interleukin-12 (IL-12)
Trial design
Treatments tested in this trial
- tolododekin alfa
- Cetrelimab