An official website of the United States government
Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers
Trial Status: active
This is a phase 1/2, multicenter, open-label study. The phase 1 portion is a dose
escalation and expansion study of STK-012 as monotherapy and in combination therapy in
patients with selected advanced solid tumors. The phase 2 portion is a randomized study
of STK-012 in combination with standard of care (SoC) pembrolizumab, pemetrexed, and
carboplatin versus SoC, in patients with first line, PD-L1 negative or STK11 mutated,
non-squamous, non-small cell lung cancer.
Inclusion Criteria
Phase 1: Selected advanced solid tumors
Phase 2:
Diagnosis of non-small cell lung cancer (NSCLC).
Stage IV or Stage IIIB/IIIC and not a candidate for definitive treatment.
Non-squamous (NSQ) cell histology.
No prior systemic therapy for advanced/metastatic NSQ NSCLC.
Must have a tumor that meets at least one of the following criteria on local testing:
PD-L1 negative (TPS <1%), OR;
STK11 mutated on tumor tissue or ctDNA
No known actionable EGFR, ALK, ROS1, or other actionable genomic aberrations for which there is a local standard of care available as front line therapy. Selected
